Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-03-02 @ 8:03 PM
Study NCT ID:
NCT00960505
Status:
COMPLETED
Last Update Posted:
2020-07-21
First Post:
2009-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Alternate Day Fasting for Weight Loss, Weight Maintenance and Cardio-protection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D031204', 'term': 'Caloric Restriction'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002149', 'term': 'Energy Intake'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'varady@uic.edu', 'phone': '3129967897', 'title': 'Krista Varady, PhD, Associate Professor', 'organization': 'University of Illinois Chicago'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '1. The duration of the maintenance phase was short (6 months).\n2. The dropout rate was higher than anticipated.\n3. We enrolled predominantly metabolically healthy obese individuals.'}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Alternate Day Fasting (ADF)', 'description': 'Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)\n\nAlternate day fasting', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Calorie Restriction (CR)', 'description': '75% energy intake every day\n\nCalorie restriction', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control', 'description': 'Usual diet\n\nControl diet', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Alternate Day Fasting (ADF)', 'description': 'Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)\n\nAlternate day fasting'}, {'id': 'OG001', 'title': 'Calorie Restriction (CR)', 'description': '75% energy intake every day\n\nCalorie restriction'}, {'id': 'OG002', 'title': 'Control', 'description': 'Usual diet'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to month 12', 'description': 'Change in body weight from baseline to month 12', 'unitOfMeasure': 'Percent change at month 12', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in HDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Alternate Day Fasting (ADF)', 'description': 'Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)\n\nAlternate day fasting'}, {'id': 'OG001', 'title': 'Calorie Restriction (CR)', 'description': '75% energy intake every day\n\nCalorie restriction'}, {'id': 'OG002', 'title': 'Control', 'description': 'Usual diet'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '-3.4', 'spread': '3.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 month interval', 'description': 'Change in HDL cholesterol from baseline to month 12', 'unitOfMeasure': 'Percent change from baseline to month 12', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Alternate Day Fasting (ADF)', 'description': 'Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)\n\nAlternate day fasting'}, {'id': 'OG001', 'title': 'Calorie Restriction (CR)', 'description': '75% energy intake every day\n\nCalorie restriction'}, {'id': 'OG002', 'title': 'Control', 'description': 'Usual diet'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.5', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '4.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 month interval', 'description': 'Change in systolic blood pressure from baseline to month 12', 'unitOfMeasure': 'Percent change from baseline to month 12', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Alternate Day Fasting (ADF)', 'description': 'Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)\n\nAlternate day fasting'}, {'id': 'OG001', 'title': 'Calorie Restriction (CR)', 'description': '75% energy intake every day\n\nCalorie restriction'}, {'id': 'OG002', 'title': 'Control', 'description': 'Usual diet'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '10.7', 'spread': '3.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 month interval', 'description': 'Change in fasting glucose from baseline to month 12', 'unitOfMeasure': 'Percent change from baseline to month 12', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Alternate Day Fasting (ADF)', 'description': 'Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)\n\nAlternate day fasting'}, {'id': 'OG001', 'title': 'Calorie Restriction (CR)', 'description': '75% energy intake every day\n\nCalorie restriction'}, {'id': 'OG002', 'title': 'Control', 'description': 'Usual diet'}], 'classes': [{'categories': [{'measurements': [{'value': '-35', 'spread': '11', 'groupId': 'OG000'}, {'value': '-28', 'spread': '9', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 month interval', 'description': 'Change in fasting insulin from baseline to month 12', 'unitOfMeasure': 'Percent change from baseline to month 12', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Insulin Resistance Measured by HOMA-IR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Alternate Day Fasting (ADF)', 'description': 'Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)\n\nAlternate day fasting'}, {'id': 'OG001', 'title': 'Calorie Restriction (CR)', 'description': '75% energy intake every day\n\nCalorie restriction'}, {'id': 'OG002', 'title': 'Control', 'description': 'Usual diet'}], 'classes': [{'categories': [{'measurements': [{'value': '-36', 'spread': '13', 'groupId': 'OG000'}, {'value': '-34', 'spread': '12', 'groupId': 'OG001'}, {'value': '12', 'spread': '16', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 month interval', 'description': 'Change in insulin resistance measured by HOMA-IR from baseline to month 12', 'unitOfMeasure': 'Percent change from baseline to month 12', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Plasma C-reactive Protein Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Alternate Day Fasting (ADF)', 'description': 'Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)\n\nAlternate day fasting'}, {'id': 'OG001', 'title': 'Calorie Restriction (CR)', 'description': '75% energy intake every day\n\nCalorie restriction'}, {'id': 'OG002', 'title': 'Control', 'description': 'Usual diet'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.9', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '-6.2', 'spread': '8.1', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '16.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 month interval', 'description': 'Change in plasma C-reactive protein concentrations from baseline to month 12', 'unitOfMeasure': 'Percent change from baseline to month 12', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Plasma Homocysteine Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Alternate Day Fasting (ADF)', 'description': 'Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)\n\nAlternate day fasting'}, {'id': 'OG001', 'title': 'Calorie Restriction (CR)', 'description': '75% energy intake every day\n\nCalorie restriction'}, {'id': 'OG002', 'title': 'Control', 'description': 'Usual diet'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '3.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 month interval', 'description': 'Change in plasma Homocysteine concentrations from baseline to month 12', 'unitOfMeasure': 'Percent change from baseline to month 12', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alternate Day Fasting (ADF)', 'description': 'Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)\n\nAlternate day fasting'}, {'id': 'FG001', 'title': 'Calorie Restriction (CR)', 'description': '75% energy intake every day\n\nCalorie restriction'}, {'id': 'FG002', 'title': 'Control', 'description': 'Usual diet\n\nControl diet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Alternate Day Fasting (ADF)', 'description': 'Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)\n\nAlternate day fasting'}, {'id': 'BG001', 'title': 'Calorie Restriction (CR)', 'description': '75% energy intake every day\n\nCalorie restriction'}, {'id': 'BG002', 'title': 'Control', 'description': 'Usual diet\n\nControl diet'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '10', 'groupId': 'BG000'}, {'value': '43', 'spread': '12', 'groupId': 'BG001'}, {'value': '44', 'spread': '11', 'groupId': 'BG002'}, {'value': '44', 'spread': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-08', 'studyFirstSubmitDate': '2009-08-14', 'resultsFirstSubmitDate': '2017-05-22', 'studyFirstSubmitQcDate': '2009-08-14', 'lastUpdatePostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-24', 'studyFirstPostDateStruct': {'date': '2009-08-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Weight', 'timeFrame': 'Baseline to month 12', 'description': 'Change in body weight from baseline to month 12'}], 'secondaryOutcomes': [{'measure': 'Change in HDL Cholesterol', 'timeFrame': '12 month interval', 'description': 'Change in HDL cholesterol from baseline to month 12'}, {'measure': 'Change in Systolic Blood Pressure', 'timeFrame': '12 month interval', 'description': 'Change in systolic blood pressure from baseline to month 12'}, {'measure': 'Change in Fasting Glucose', 'timeFrame': '12 month interval', 'description': 'Change in fasting glucose from baseline to month 12'}, {'measure': 'Change in Fasting Insulin', 'timeFrame': '12 month interval', 'description': 'Change in fasting insulin from baseline to month 12'}, {'measure': 'Change in Insulin Resistance Measured by HOMA-IR', 'timeFrame': '12 month interval', 'description': 'Change in insulin resistance measured by HOMA-IR from baseline to month 12'}, {'measure': 'Change in Plasma C-reactive Protein Concentrations', 'timeFrame': '12 month interval', 'description': 'Change in plasma C-reactive protein concentrations from baseline to month 12'}, {'measure': 'Change in Plasma Homocysteine Concentrations', 'timeFrame': '12 month interval', 'description': 'Change in plasma Homocysteine concentrations from baseline to month 12'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diet', 'Coronary heart disease', 'Obesity', 'Weight loss', 'Weight maintenance'], 'conditions': ['Coronary Heart Disease', 'Obesity', 'Weight Loss']}, 'referencesModule': {'references': [{'pmid': '33512717', 'type': 'DERIVED', 'citation': 'Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.'}, {'pmid': '33358713', 'type': 'DERIVED', 'citation': 'Lin S, Lima Oliveira M, Gabel K, Kalam F, Cienfuegos S, Ezpeleta M, Bhutani S, Varady KA. Does the weight loss efficacy of alternate day fasting differ according to sex and menopausal status? Nutr Metab Cardiovasc Dis. 2021 Feb 8;31(2):641-649. doi: 10.1016/j.numecd.2020.10.018. Epub 2020 Oct 31.'}, {'pmid': '31328895', 'type': 'DERIVED', 'citation': 'Gabel K, Kroeger CM, Trepanowski JF, Hoddy KK, Cienfuegos S, Kalam F, Varady KA. Differential Effects of Alternate-Day Fasting Versus Daily Calorie Restriction on Insulin Resistance. Obesity (Silver Spring). 2019 Sep;27(9):1443-1450. doi: 10.1002/oby.22564. Epub 2019 Jul 22.'}, {'pmid': '30297199', 'type': 'DERIVED', 'citation': 'Miranda ER, Fuller KNZ, Perkins RK, Kroeger CM, Trepanowski JF, Varady KA, Haus JM. Endogenous secretory RAGE increases with improvements in body composition and is associated with markers of adipocyte health. Nutr Metab Cardiovasc Dis. 2018 Nov;28(11):1155-1165. doi: 10.1016/j.numecd.2018.07.009. Epub 2018 Aug 2.'}, {'pmid': '29258678', 'type': 'DERIVED', 'citation': 'Trepanowski JF, Kroeger CM, Barnosky A, Klempel M, Bhutani S, Hoddy KK, Rood J, Ravussin E, Varady KA. Effects of alternate-day fasting or daily calorie restriction on body composition, fat distribution, and circulating adipokines: Secondary analysis of a randomized controlled trial. Clin Nutr. 2018 Dec;37(6 Pt A):1871-1878. doi: 10.1016/j.clnu.2017.11.018. Epub 2017 Dec 5.'}, {'pmid': '28459931', 'type': 'DERIVED', 'citation': 'Trepanowski JF, Kroeger CM, Barnosky A, Klempel MC, Bhutani S, Hoddy KK, Gabel K, Freels S, Rigdon J, Rood J, Ravussin E, Varady KA. Effect of Alternate-Day Fasting on Weight Loss, Weight Maintenance, and Cardioprotection Among Metabolically Healthy Obese Adults: A Randomized Clinical Trial. JAMA Intern Med. 2017 Jul 1;177(7):930-938. doi: 10.1001/jamainternmed.2017.0936.'}]}, 'descriptionModule': {'briefSummary': 'The proposed research will demonstrate that alternate day modified fasting (ADMF) is a suitable alternative to daily calorie restriction (CR) for weight loss, weight maintenance, and heart disease prevention. Since many overweight and obese individuals find it difficult to adhere to daily CR, this diet option may improve adherence with these dietary restriction protocols. This, in turn, will allow a greater percent of the overweight and obese population to lose weight, maintain weight loss, and prevent future occurrences of coronary heart disease.', 'detailedDescription': 'Overweight and obese individuals are at increased risk for coronary heart disease (CHD). Losing weight by means of dietary restriction greatly reduces vascular disease risk. The majority of studies examiningmost common dietary restriction protocol s implemented is daily calorie restriction (CR). Another dietary restriction regimen employed, although far less commonly, is alternate day modified fasting (ADMF). ADMF involves a "feed day" where food is consumed ad-libitum, alternated with a "fast day", where food intake is partially reduced. Previous reports show that adherence to ADMF exceeds that of CR after 8 weeks of treatment. This increased adherence to ADMF results in greater weight loss, which produces more pronounced improvements in CHD risk. What has yet to be determined is whether adherence to ADMF remains near maximal for longer treatment durations (24 weeks), and if this improved adherence results in greater reductions in body weight and CHD risk, versus CR. Once weight loss is achieved, weight maintenance is extremely important as CHD risk can increase if weight is regained. Whether ADMF is an effective strategy for weight maintenance remains unknown. Accordingly, the aims of this proposal are: Aim 1: To establish that adherence to ADMF is greater than that of CR during a 24-week intervention period and to determine if increased adherence to ADMF results in greater weight loss; Aim 2: To establish that greater reductions in body weight by ADMF over a 24-week period will result in greater improvements in traditional CHD risk parameters (blood pressure, plasma lipid levels, cholesterol synthesis rate, LDL particle size, and CRP) and emerging CHD risk parameters (fat cell-derived hormones, body fat distribution, and fat cell size) in comparison to CR; and Aim 3: To establish that ADMF is an effective diet therapy to maintain weight loss and sustain improvements in CHD risk indicators, and to compare changes in cognitive and behavioral components of eating between ADMF and CR subjects. A 52-week randomized, controlled, parallel-arm feeding trial will be implemented to test these objectives. The trial will be divided into 3 consecutive intervention periods: (1) 4-week baseline; (2) 24-week weight loss with food provided; and (3) 24-week weight maintenance with no food provided. Overweight and obese subjects (n = 90) will be randomized to 1 of 3 groups: (1) ADMF, 75% energy restriction on the "fast day" and ad libitum fed on the "feed day"; (2) CR, 25% restriction everyday; or 3) control, 100% energy intake everyday. During the weight maintenance phase, ADMF subjects will consume 25% of their energy needs on the "fast day" and 175% of their needs on the "feed day", while CR and control subjects will consume 100% of their needs everyday. Our findings will show that ADMF can be implemented as an alternative to CR to help overweight and obese individuals lose weight, maintain weight loss, and sustain reductions in CHD risk. This study will also generate insights into the specific behavioral changes that occur with ADMF that explain why ADMF is a successful diet strategy for weight maintenance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria. Adult subjects meeting the following criteria will be eligible to participate:\n\n* Age between 18 to 65 years old\n* BMI between 25.0 and 39.9 kg/m2\n* Previously sedentary (\\<60 minutes/week of light activity corresponding to 2.5 to 4.0 metabolic equivalents (METs) for the 3 months prior to the study)\n\nExclusion criteria. Subjects excluded from participating in the study include those who:\n\n* Have a history cardiovascular disease (prior angina, myocardial infarction or stroke)\n* Are diabetic (fasting blood glucose \\> 126 mg/dl)\n* Have a history of psychiatric disorders and/or eating disorders\n* Are taking anti-depressant or anti-anxiety medications\n* Are taking drugs that affect study outcomes (weight loss, lipid-lowering, or blood pressure drugs)\n* Are not weight stable for 3 months prior to the beginning of study (weight gain or loss \\> 4 kg)\n* Are not able to keep a food diary or activity log for 7 consecutive days during screening\n* Are perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days)\n* Are claustrophobic or have implanted electrical devices (cardiac pacemaker or a neurostimulator)\n* Are pregnant, or trying to become pregnant\n* Are smokers'}, 'identificationModule': {'nctId': 'NCT00960505', 'briefTitle': 'Alternate Day Fasting for Weight Loss, Weight Maintenance and Cardio-protection', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Alternate Day Fasting for Weight Loss, Weight Maintenance and Cardio-protection', 'orgStudyIdInfo': {'id': '2010-0118'}, 'secondaryIdInfos': [{'id': 'R01HL106228', 'link': 'https://reporter.nih.gov/quickSearch/R01HL106228', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alternate day fasting (ADF)', 'description': 'Fast day diet: 25% energy intake, Feast day diet: Ad libitum energy intake (alternating days)', 'interventionNames': ['Other: Alternate day fasting']}, {'type': 'EXPERIMENTAL', 'label': 'Calorie restriction (CR)', 'description': '75% energy intake every day', 'interventionNames': ['Other: Calorie restriction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Usual diet', 'interventionNames': ['Other: Control diet']}], 'interventions': [{'name': 'Alternate day fasting', 'type': 'OTHER', 'armGroupLabels': ['Alternate day fasting (ADF)']}, {'name': 'Calorie restriction', 'type': 'OTHER', 'armGroupLabels': ['Calorie restriction (CR)']}, {'name': 'Control diet', 'type': 'OTHER', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60622', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois, Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Krista Varady, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Krista Varady', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}