Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-30 @ 5:17 PM
Study NCT ID:
NCT04061369
Status:
TERMINATED
Last Update Posted:
2023-05-15
First Post:
2019-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Energy Expenditure and Substrate Oxidation in a Whole Room Calorimeter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Both the investigator and the participant will be aware of the group assignment. The persons handling the data and statistics will not be aware of the group assignment.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will be a randomized design that includes a volunteer receiving one of four test meals.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'After Covid-19 pandemic, room calorimeter not functional', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2019-07-22', 'studyFirstSubmitQcDate': '2019-08-16', 'lastUpdatePostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline level and change in rate of oxygen consumption', 'timeFrame': 'Measured continuously from baseline up to 600 minutes post-meal', 'description': 'Oxygen consumption rate (VO2/min) measured by gas analyzer while inside whole room calorimeter'}, {'measure': 'Baseline level and change in rate of carbon dioxide production', 'timeFrame': 'Measured continuously from baseline up to 600 minutes post-meal', 'description': 'Carbon dioxide production rate (VCO2/min) measured by gas analyzer while inside whole room calorimeter'}, {'measure': 'Baseline level and change in respiratory exchange ratio (RER)', 'timeFrame': 'Measured continuously from baseline up to 600 minutes post-meal', 'description': 'RER is expressed as the ratio of VCO2 to VO2'}, {'measure': 'Baseline level and change in urinary nitrogen excretion', 'timeFrame': 'Measured from discrete specimens and a pooled urine sample collected up to 600 minutes post-meal while in the room calorimeter', 'description': 'Urinary nitrogen measured via combustion and gas analysis in mg'}], 'secondaryOutcomes': [{'measure': 'Body weight', 'timeFrame': 'Baseline', 'description': 'measured in kg'}, {'measure': 'Body fat', 'timeFrame': 'Baseline', 'description': 'Measured in kg using multi frequency bioimpedance'}, {'measure': 'Lean body mass', 'timeFrame': 'Baseline', 'description': 'Measured in kg using multi frequency bioimpedance'}, {'measure': 'Total body water', 'timeFrame': 'Baseline', 'description': 'Measured in kg using multi frequency bioimpedance'}, {'measure': 'Waist circumference', 'timeFrame': 'Baseline', 'description': 'measured in cm'}, {'measure': 'Hip circumference', 'timeFrame': 'Baseline', 'description': 'measured in cm'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline', 'description': 'Both systolic and diastolic pressure measured in mmHg using automated instrument'}, {'measure': 'Heart rate', 'timeFrame': 'Baseline', 'description': 'measured in beats per minute using automated instrument'}, {'measure': 'Body temperature', 'timeFrame': 'Baseline', 'description': 'measured in centigrade'}, {'measure': 'General health and well-being', 'timeFrame': 'Baseline', 'description': 'The SF-36 Short form general health and well-being questionnaire measured once. The survey has eight scales; physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health. All 36 items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Items in the same scale are averaged together to create the 8 scale scores.'}, {'measure': 'Usual physical activity', 'timeFrame': 'Baseline', 'description': 'Physical activity estimated from the Stanford Brief Physical Activity questionnaire. Scale is categorical for two subscales: work physical activity and leisure time activity.'}, {'measure': 'Baseline level and change in satiety', 'timeFrame': 'Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal', 'description': 'Self-reported feelings of fullness measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."'}, {'measure': 'Baseline level and change in hunger', 'timeFrame': 'Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal', 'description': 'Self-reported feelings of hunger measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."'}, {'measure': 'Baseline level and change in desire to eat', 'timeFrame': 'Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal', 'description': 'Self-reported feelings of the desire to eat measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."'}, {'measure': 'Baseline level and change in prospective consumption', 'timeFrame': 'Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal', 'description': 'Self-reported feelings of prospective consumption measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."'}, {'measure': 'Baseline level and change in energy expenditure', 'timeFrame': 'Expressed from baseline up to 600 minutes post-meal', 'description': 'Calculated as kcal/min from oxygen consumption and carbon dioxide production (L/min) and urinary nitrogen excretion (g/min)'}, {'measure': 'Baseline level and change in carbohydrate combustion', 'timeFrame': 'Expressed from baseline up to 600 minutes post-meal', 'description': 'Calculated as g/min from oxygen consumption and carbon dioxide production (L/min) and urinary nitrogen excretion (g/min)'}, {'measure': 'Baseline level and change in fat combustion', 'timeFrame': 'Expressed from baseline up to 600 minutes post-meal', 'description': 'Calculated as g/min from oxygen consumption and carbon dioxide production (L/min) and urinary nitrogen excretion (g/min)'}, {'measure': 'Baseline level and change in thermic effect of food (TEF)', 'timeFrame': 'Expressed from baseline up to 600 minutes post-meal', 'description': 'Calculated as the increase in post-meal energy expenditure above baseline energy expenditure'}, {'measure': 'Baseline level and change in heart rate', 'timeFrame': 'Expressed from baseline up to 600 minutes post-meal', 'description': 'Heart rate is estimated from wrist-worn activity monitor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thermic effect of feeding', 'thermogenesis', 'calorimeter', 'fuel utilization'], 'conditions': ['Overweight', 'Obesity', 'Body Weight']}, 'descriptionModule': {'briefSummary': 'The investigators aim to establish a protocol for metabolic rate measurements obtained using continuous monitoring of oxygen consumption and carbon dioxide production in a whole room calorimeter setting.', 'detailedDescription': 'The purpose of this study is to determine the duration and time course of the thermic effect of single meals consumed by subjects who have been previously fasting for 12 hours overnight. Capturing the full thermic effect of a meal may take up to 8 hours, depending on the calorie load, nutrient composition of the meal, and rate of digestion. The investigators will test meals consisting of conventional foods that are low (20% of energy), moderate (40% of energy) or high (60% of energy) in fat calories, as fat is thought to slow the digestive process. The investigators will test a liquid meal, that is high (60% of energy) in fat calories, as liquid foods are thought to move more quickly through the digestive process. Another purpose of this study is to determine the test-retest reproducibility for the meals described above. To accomplish reproducibility, a volunteer will be permitted to repeat a test day two times using the same test meal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body Mass Index 18.5 - 39.9 kg/m2\n\nExclusion Criteria:\n\n* BMI \\< 18.5 or \\> 40 kg/m2\n* Presence of untreated or uncontrolled metabolic diseases\n* Presence of gastrointestinal distress or disorders that prevent consumption of a study meal (in particular, the high fat meals)\n* Presence of Crohn's disease, irritable bowel syndrome, or colitis\n* Previous gallbladder removal\n* Presence of cancer or other serious chronic disease\n* Implanted medical device that is battery operated, such as a pacemaker, defibrillator, electrocardiograph, or nerve simulator\n* Presence of a large amount of metal in the body such as a hip implant\n* Current use of tobacco in any form\n* Claustrophobia\n* Dietary restrictions that would interfere with consuming study meals\n* Pregnant or nursing within the last 6 months, or plan to become pregnant"}, 'identificationModule': {'nctId': 'NCT04061369', 'briefTitle': 'Energy Expenditure and Substrate Oxidation in a Whole Room Calorimeter', 'organization': {'class': 'FED', 'fullName': 'USDA, Western Human Nutrition Research Center'}, 'officialTitle': 'Establishing Short-term Protocols for Measuring Resting and Postprandial Energy Expenditure and Substrate Oxidation in a Whole Room Calorimeter', 'orgStudyIdInfo': {'id': 'FL106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meal 1', 'description': 'Meal consisting of conventional foods that is low (20% of energy) in fat calories.', 'interventionNames': ['Other: Low fat meal']}, {'type': 'EXPERIMENTAL', 'label': 'Meal 2', 'description': 'Meal consisting of conventional foods that is moderate (40% of energy) in fat calories.', 'interventionNames': ['Other: Moderate fat meal']}, {'type': 'EXPERIMENTAL', 'label': 'Meal 3', 'description': 'Meal consisting of conventional foods that is high (60% of energy) in fat calories.', 'interventionNames': ['Other: High fat meal']}, {'type': 'EXPERIMENTAL', 'label': 'Meal 4', 'description': 'A liquid meal, similar to a "smoothie", that is high (60% of energy) in fat calories.', 'interventionNames': ['Other: High fat liquid meal']}], 'interventions': [{'name': 'Low fat meal', 'type': 'OTHER', 'description': 'Meal consisting of conventional foods that is low (20% of energy) in fat calories.', 'armGroupLabels': ['Meal 1']}, {'name': 'Moderate fat meal', 'type': 'OTHER', 'description': 'Meal consisting of conventional foods that is moderate (40% of energy) in fat calories.', 'armGroupLabels': ['Meal 2']}, {'name': 'High fat meal', 'type': 'OTHER', 'description': 'Meal consisting of conventional foods that is high (60% of energy) in fat calories.', 'armGroupLabels': ['Meal 3']}, {'name': 'High fat liquid meal', 'type': 'OTHER', 'description': 'Liquid meal that is high (60% of energy) in fat calories.', 'armGroupLabels': ['Meal 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'USDA, ARS, Western Human Nutrition Research Center', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USDA, Western Human Nutrition Research Center', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}