Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-29 @ 9:04 AM
Study NCT ID:
NCT03937960
Status:
COMPLETED
Last Update Posted:
2022-12-22
First Post:
2019-04-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Low Carbohydrate Versus Low Fat Diet in the Treatment of Dyslipidemia in Obese Children With Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dr.bhuvana.s@gmail.com', 'phone': '2056389107', 'title': 'Dr. Bhuvana Sunil', 'organization': 'University of Alabama at Birmingham'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Each participant was assessed for adverse events during the duration of their participation for 8 weeks and additionally, for 8 weeks after their completion in the study for a total duration of 16 weeks from the time of enrollment in the study', 'eventGroups': [{'id': 'EG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dyslipidemia Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '2', 'groupId': 'OG000'}, {'value': '32', 'spread': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Baseline concentration of serum High-density Lipoprotein level in mg/dL', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dyslipidemia Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Change in concentration of serum High density Lipoprotein in mg/dL', 'unitOfMeasure': 'mg/dL increase', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dyslipidemia Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '160', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '163', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Baseline concentration of serum Triglyceride level in mg/dL', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dyslipidemia Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.7', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '-8.5', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Change in concentration of serum Triglyceride level in mg/dL', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dyslipidemia Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '822', 'spread': '125.6', 'groupId': 'OG000'}, {'value': '821.6', 'spread': '120.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Baseline concentration of serum lipoprotein particle number', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dyslipidemia Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.052', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '-0.036', 'spread': '0.016', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Change in concentration of serum lipoprotein particle number in percentage', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dyslipidemia Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '76.2', 'spread': '8.36', 'groupId': 'OG000'}, {'value': '77.1', 'spread': '9.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Baseline concentration of serum lipoprotein particle concentration', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dyslipidemia Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.062', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '-0.0617', 'spread': '0.003', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Change in concentration of serum lipoprotein particle concentration in percentage', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dyslipidemia Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '30.5', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '30.62', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Baseline total serum high density lipoprotein particle number', 'unitOfMeasure': 'micromol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dyslipidemia Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '02.76', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '02.80', 'spread': '0.051', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8 weeks', 'description': 'percentage Change in concentration of serum high density lipoprotein particle', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dyslipidemia Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '413.6', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '418.2', 'spread': '19.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Baseline concentration of serum small low-density lipoprotein particle concentration', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dyslipidemia Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.6', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '-8.15', 'spread': '0.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Percentage change in concentration of serum small low density lipoprotein particle', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dyslipidemia Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '21.62', 'spread': '1.87', 'groupId': 'OG000'}, {'value': '21.72', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Baseline serum low-density lipoprotein size', 'unitOfMeasure': 'nm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dyslipidemia Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '1.65', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '1.68', 'spread': '0.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Percentage change in concentration of serum small low-density lipoprotein size', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Insulin Resistance Indices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.87', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '-7.65', 'spread': '1.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Percentage change in Serum measure of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)\n\nHOMA\\_IR is a scale where a higher number means worse outcome', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Insulin Resistance Indices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '2.15', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '2.21', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)\n\nHOMA\\_IR is a scale where a higher number means worse outcome', 'unitOfMeasure': 'index score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Composition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '43.2', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '45.6', 'spread': '4.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Dual-energy X-ray absorptiometry (DXA) - measure of body fat', 'unitOfMeasure': '% of total body weight', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Composition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.7', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '-8.84', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Percent Change in Dual-energy X-ray absorptiometry (DXA) body fat', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Surrogate Markers of Vascular Endothelial Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'spread': '1', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Baseline Pulse wave velocity', 'unitOfMeasure': 'm/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Surrogate Markers of Vascular Endothelial Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '-2', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-2', 'spread': '1.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Percentage Change in Pulse wave velocity', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '81.8', 'spread': '7.98', 'groupId': 'OG000'}, {'value': '88.7', 'spread': '8.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The Augmentation Index a measure of peripheral arterial stiffness', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'OG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'classes': [{'categories': [{'measurements': [{'value': '-27', 'spread': '1', 'groupId': 'OG000'}, {'value': '-28.6', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8 weeks', 'description': 'The Augmentation Index a measure of peripheral arterial stiffness', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'FG001', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Carbohydrate Restricted Group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.\n\nCarbohydrate restricted group: Prescribed low carbohydrate diet with set recipes'}, {'id': 'BG001', 'title': 'Standard/Low Fat Diet Group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.\n\nStandard low fat diet: Diet with less than 20% total calorie intake from dietary fats'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12', 'spread': '1', 'groupId': 'BG000'}, {'value': '12', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '12', 'spread': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-06', 'size': 161933, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-06T19:59', 'hasProtocol': True}, {'date': '2022-10-06', 'size': 78282, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-06T19:59', 'hasProtocol': False}, {'date': '2019-01-15', 'size': 276206, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-10-06T20:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-29', 'studyFirstSubmitDate': '2019-04-24', 'resultsFirstSubmitDate': '2022-08-04', 'studyFirstSubmitQcDate': '2019-05-01', 'lastUpdatePostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-29', 'studyFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dyslipidemia Measures', 'timeFrame': 'Baseline', 'description': 'Baseline concentration of serum High-density Lipoprotein level in mg/dL'}, {'measure': 'Dyslipidemia Measures', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Change in concentration of serum High density Lipoprotein in mg/dL'}, {'measure': 'Dyslipidemia Measures', 'timeFrame': 'Baseline', 'description': 'Baseline concentration of serum Triglyceride level in mg/dL'}, {'measure': 'Dyslipidemia Measures', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Change in concentration of serum Triglyceride level in mg/dL'}, {'measure': 'Dyslipidemia Measures', 'timeFrame': 'Baseline', 'description': 'Baseline concentration of serum lipoprotein particle number'}, {'measure': 'Dyslipidemia Measures', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Change in concentration of serum lipoprotein particle number in percentage'}, {'measure': 'Dyslipidemia Measures', 'timeFrame': 'Baseline', 'description': 'Baseline concentration of serum lipoprotein particle concentration'}, {'measure': 'Dyslipidemia Measures', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Change in concentration of serum lipoprotein particle concentration in percentage'}, {'measure': 'Dyslipidemia Measures', 'timeFrame': 'Baseline', 'description': 'Baseline total serum high density lipoprotein particle number'}, {'measure': 'Dyslipidemia Measures', 'timeFrame': 'Baseline to 8 weeks', 'description': 'percentage Change in concentration of serum high density lipoprotein particle'}, {'measure': 'Dyslipidemia Measures', 'timeFrame': 'Baseline', 'description': 'Baseline concentration of serum small low-density lipoprotein particle concentration'}, {'measure': 'Dyslipidemia Measures', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Percentage change in concentration of serum small low density lipoprotein particle'}, {'measure': 'Dyslipidemia Measures', 'timeFrame': 'Baseline', 'description': 'Baseline serum low-density lipoprotein size'}, {'measure': 'Dyslipidemia Measures', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Percentage change in concentration of serum small low-density lipoprotein size'}, {'measure': 'Insulin Resistance Indices', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Percentage change in Serum measure of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)\n\nHOMA\\_IR is a scale where a higher number means worse outcome'}], 'secondaryOutcomes': [{'measure': 'Insulin Resistance Indices', 'timeFrame': 'Baseline', 'description': 'Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)\n\nHOMA\\_IR is a scale where a higher number means worse outcome'}, {'measure': 'Body Composition', 'timeFrame': 'Baseline', 'description': 'Dual-energy X-ray absorptiometry (DXA) - measure of body fat'}, {'measure': 'Body Composition', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Percent Change in Dual-energy X-ray absorptiometry (DXA) body fat'}, {'measure': 'Surrogate Markers of Vascular Endothelial Function', 'timeFrame': 'Baseline', 'description': 'Baseline Pulse wave velocity'}, {'measure': 'Surrogate Markers of Vascular Endothelial Function', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Percentage Change in Pulse wave velocity'}, {'measure': 'Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index', 'timeFrame': 'Baseline', 'description': 'The Augmentation Index a measure of peripheral arterial stiffness'}, {'measure': 'Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index', 'timeFrame': 'Baseline to 8 weeks', 'description': 'The Augmentation Index a measure of peripheral arterial stiffness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dietary intervention', 'Anthropometric measure', 'Lipid profile', 'Augmentation Index', 'Flow mediated dilation', 'DXA scan', 'Nuclear magnetic resonance lipid profile'], 'conditions': ['Metabolic Syndrome', 'Obesity', 'Dyslipidemias']}, 'descriptionModule': {'briefSummary': 'Two-arm, parallel design with children between the ages of 10 - 18 with obesity and metabolic syndrome randomized (15 per group) to reduced-carbohydrate diet or a reduced-fat diet for 8 weeks.', 'detailedDescription': 'Two-arm, parallel design with participants randomized (15 per group) to reduced-carbohydrate diet or a reduced-fat diet for 8 weeks. Anthropometric evaluations, lab work for lipid levels, insulin and C peptide levels, resting energy expenditure evaluation, DXA scan and cardiovascular markers will occur at baseline during the initial clinic visit. Individual dietary counseling will be provided at baseline and as well as weekly diet-specific support will be provided with a phone call from the PI. Dietary intake will be assessed with weekly food records (weeks 1-8). The return visit on week 8 will include a visit identical to the initial visit except the resting energy expenditure will not be revaluated, and the participants will be asked to answer a questionnaire about the diet they were consuming.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: 3 out of 5 of the following criteria\n\n* Metabolic syndrome with dyslipidemia\n* (HDL \\<40mg/dL\n* Triglyceride (TG) TG\\>150mg/dL)\n* Glucose intolerance (fasting blood sugar \\>100mg/dL)\n* Central adiposity (Waist circumference ≥90th percentile or adult cutoff if lower)\n* Systolic BP ≥130 mm Hg or diastolic BP ≥85 mm Hg or treatment of previously diagnosed hypertension\n\nExclusion Criteria:\n\n* Patient on medications known to induce dyslipidemia (systemic steroids, immunosuppressants)\n* Pregnancy\n* Untreated thyroid disease, heart disease, cancer, kidney disease\n* Children on statin/fibrate treatments or other lipid-lowering medications\n* Prior surgical procedure for weight control or current weight loss medication'}, 'identificationModule': {'nctId': 'NCT03937960', 'briefTitle': 'Effect of Low Carbohydrate Versus Low Fat Diet in the Treatment of Dyslipidemia in Obese Children With Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Effect of Carbohydrate Restricted Versus Standard Low Fat Diet in the Treatment of Dyslipidemia in Children With Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'IRB-300002816'}, 'secondaryIdInfos': [{'id': 'P30DK056336', 'link': 'https://reporter.nih.gov/quickSearch/P30DK056336', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Carbohydrate restricted group', 'description': 'This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.', 'interventionNames': ['Other: Carbohydrate restricted group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard/Low fat diet group', 'description': 'The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.', 'interventionNames': ['Other: Standard low fat diet']}], 'interventions': [{'name': 'Carbohydrate restricted group', 'type': 'OTHER', 'description': 'Prescribed low carbohydrate diet with set recipes', 'armGroupLabels': ['Carbohydrate restricted group']}, {'name': 'Standard low fat diet', 'type': 'OTHER', 'description': 'Diet with less than 20% total calorie intake from dietary fats', 'armGroupLabels': ['Standard/Low fat diet group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Bhuvana Sunil', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Bhuvana Sunil, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Bhuvana Sunil', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}