Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-02-20 @ 6:38 PM
Study NCT ID:
NCT02939404
Status:
COMPLETED
Last Update Posted:
2025-07-04
First Post:
2016-10-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Food Intake Response to Short-Term Modifications of Metabolism in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C407088', 'term': 'Angptl4 protein, mouse'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Douglas.Chang@nih.gov', 'phone': '602.200.5312', 'title': 'Douglas C. Chang, MD', 'organization': 'Obesity & Diabetes Clinical Research Section, NIDDK'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Chamber at 19°C With Fixed Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)", 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 2, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2. Chamber at 19°C, ad Libitum Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)", 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 1, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gastroesophageal reflux disease symptoms at Chamber at 24°C, fixed diet', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroesophageal reflux disease symptoms at Chamber at 19°C, fixed diet', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '24-hour Energy Expenditure (kcal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chamber at 19°C With Fixed Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}, {'id': 'OG001', 'title': '2. Chamber at 19°C, ad Libitum Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}], 'classes': [{'title': 'Chamber at 24°C, fixed diet', 'categories': [{'measurements': [{'value': '2256', 'spread': '393', 'groupId': 'OG000'}, {'value': '2166', 'spread': '302', 'groupId': 'OG001'}]}]}, {'title': 'Chamber at 24°C, ad libitum diet', 'categories': [{'measurements': [{'value': '2563', 'spread': '422', 'groupId': 'OG000'}, {'value': '2487', 'spread': '385', 'groupId': 'OG001'}]}]}, {'title': 'Chamber at 19°C, fixed diet', 'categories': [{'measurements': [{'value': '2271', 'spread': '360', 'groupId': 'OG000'}, {'value': '2153', 'spread': '304', 'groupId': 'OG001'}]}]}, {'title': 'Chamber at 19°C, ad libitum diet', 'categories': [{'measurements': [{'value': '2552', 'spread': '418', 'groupId': 'OG000'}, {'value': '2505', 'spread': '401', 'groupId': 'OG001'}]}]}, {'title': 'Chamber at 24°C, fasting', 'categories': [{'measurements': [{'value': '2135', 'spread': '337', 'groupId': 'OG000'}, {'value': '1998', 'spread': '296', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 6 (Chamber at 24°C, fixed diet), 10(Chamber at 24°C, ad libitum diet), 14(Chamber at 19°C, fixed or ad libitum diet), 18(Chamber at 19°C, fixed or ad libitum diet), and 21(Chamber at 24°C, fasting)', 'description': 'Energy expenditure (EE) as measured during 24 hours in a whole-room calorimeter', 'unitOfMeasure': 'kcal', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '24-hour Energy Intake (kcal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chamber at 19°C With Fixed Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}, {'id': 'OG001', 'title': '2. Chamber at 19°C, ad Libitum Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}], 'classes': [{'title': 'Chamber at 24°C, fixed diet', 'categories': [{'measurements': [{'value': '3811', 'spread': '1140', 'groupId': 'OG000'}, {'value': '3694', 'spread': '1503', 'groupId': 'OG001'}]}]}, {'title': 'Chamber at 24°C, ad libitum diet', 'categories': [{'measurements': [{'value': '4091', 'spread': '1054', 'groupId': 'OG000'}, {'value': '4359', 'spread': '1404', 'groupId': 'OG001'}]}]}, {'title': 'Chamber at 19°C, fixed diet', 'categories': [{'measurements': [{'value': '4014', 'spread': '1136', 'groupId': 'OG000'}, {'value': '4075', 'spread': '1587', 'groupId': 'OG001'}]}]}, {'title': 'Chamber at 19°C, ad libitum diet', 'categories': [{'measurements': [{'value': '4509', 'spread': '1255', 'groupId': 'OG000'}, {'value': '4762', 'spread': '1610', 'groupId': 'OG001'}]}]}, {'title': 'Chamber at 24°C, fasting', 'categories': [{'measurements': [{'value': '3795', 'spread': '1223', 'groupId': 'OG000'}, {'value': '4112', 'spread': '1406', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 6 (Chamber at 24°C, fixed diet), 10(Chamber at 24°C, ad libitum diet), 14(Chamber at 19°C, fixed or ad libitum diet), 18(Chamber at 19°C, fixed or ad libitum diet), and 21(Chamber at 24°C, fasting)', 'description': 'Energy intake as measured during 24 hours in a whole-room calorimeter', 'unitOfMeasure': 'kcal', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '24- Hour Respiratory Quotient (RQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chamber at 19°C With Fixed Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}, {'id': 'OG001', 'title': '2. Chamber at 19°C, ad Libitum Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}], 'classes': [{'title': 'Chamber at 24°C, fixed diet', 'categories': [{'measurements': [{'value': '0.868', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '0.868', 'spread': '0.029', 'groupId': 'OG001'}]}]}, {'title': 'Chamber at 24°C, ad libitum diet', 'categories': [{'measurements': [{'value': '0.925', 'spread': '0.056', 'groupId': 'OG000'}, {'value': '0.935', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Chamber at 19°C, fixed diet', 'categories': [{'measurements': [{'value': '0.872', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.867', 'spread': '0.032', 'groupId': 'OG001'}]}]}, {'title': 'Chamber at 19°C, ad libitum diet', 'categories': [{'measurements': [{'value': '0.909', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '0.916', 'spread': '0.045', 'groupId': 'OG001'}]}]}, {'title': 'Chamber at 24°C, fasting', 'categories': [{'measurements': [{'value': '0.793', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '0.789', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 6 (Chamber at 24°C, fixed diet), 10(Chamber at 24°C, ad libitum diet), 14(Chamber at 19°C, fixed or ad libitum diet), 18(Chamber at 19°C, fixed or ad libitum diet), and 21(Chamber at 24°C, fasting)', 'description': 'RQ, an approximation for the ratio of carbohydrate-to-fat oxidation rates, is measured while in the chamber', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Leptin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chamber at 19°C With Fixed Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}, {'id': 'OG001', 'title': '2. Chamber at 19°C, ad Libitum Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}], 'classes': [{'title': 'Chamber at 24°C, fixed diet', 'categories': [{'measurements': [{'value': '26.1', 'spread': '26.4', 'groupId': 'OG000'}, {'value': '26.5', 'spread': '30.5', 'groupId': 'OG001'}]}]}, {'title': 'Chamber at 19°C, fixed diet', 'categories': [{'measurements': [{'value': '29.5', 'spread': '30.1', 'groupId': 'OG000'}, {'value': '27.8', 'spread': '30.3', 'groupId': 'OG001'}]}]}, {'title': 'Chamber at 24°C, fasting', 'categories': [{'measurements': [{'value': '18.3', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '22.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 6 (Chamber at 24°C, fixed diet), 14(Chamber at 19°C, fixed diet) or 18(Chamber at 19°C, fixed diet), and 21(Chamber at 24°C, fasting)', 'description': 'Plasma leptin (ng/ml)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Secretin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chamber at 19°C With Fixed Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}, {'id': 'OG001', 'title': '2. Chamber at 19°C, ad Libitum Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}], 'classes': [{'title': '(Chamber at 24°C, fixed diet', 'categories': [{'measurements': [{'value': '0.91', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': '(Chamber at 19°C, fixed diet', 'categories': [{'measurements': [{'value': '1.03', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': '(Chamber at 24°C, fasting', 'categories': [{'measurements': [{'value': '0.99', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '0.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 6 (Chamber at 24°C, fixed diet), 14(Chamber at 19°C, fixed diet) or 18(Chamber at 19°C, fixed diet), and 21(Chamber at 24°C, fasting)', 'description': 'Plasma secretin (ng/ml)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ghrelin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chamber at 19°C With Fixed Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}, {'id': 'OG001', 'title': '2. Chamber at 19°C, ad Libitum Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}], 'classes': [{'title': 'Chamber at 24°C, fixed diet', 'categories': [{'measurements': [{'value': '502', 'spread': '254', 'groupId': 'OG000'}, {'value': '644', 'spread': '274', 'groupId': 'OG001'}]}]}, {'title': 'Chamber at 19°C, fixed diet', 'categories': [{'measurements': [{'value': '544', 'spread': '277', 'groupId': 'OG000'}, {'value': '605', 'spread': '311', 'groupId': 'OG001'}]}]}, {'title': 'Chamber at 24°C, fasting', 'categories': [{'measurements': [{'value': '575', 'spread': '293', 'groupId': 'OG000'}, {'value': '581', 'spread': '304', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 6 (Chamber at 24°C, fixed diet), 14(Chamber at 19°C, fixed diet) or 18(Chamber at 19°C, fixed diet), and 21(Chamber at 24°C, fasting)', 'description': 'Plasma grehlin (pg/ml)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'FGF-21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chamber at 19°C With Fixed Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}, {'id': 'OG001', 'title': '2. Chamber at 19°C, ad Libitum Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}], 'classes': [{'title': 'Chamber at 24°C, fixed diet', 'categories': [{'measurements': [{'value': '94', 'spread': '73', 'groupId': 'OG000'}, {'value': '98', 'spread': '72', 'groupId': 'OG001'}]}]}, {'title': 'Chamber at 19°C, fixed diet', 'categories': [{'measurements': [{'value': '98', 'spread': '81', 'groupId': 'OG000'}, {'value': '113', 'spread': '90', 'groupId': 'OG001'}]}]}, {'title': 'Chamber at 24°C, fasting', 'categories': [{'measurements': [{'value': '106', 'spread': '66', 'groupId': 'OG000'}, {'value': '108', 'spread': '76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 6 (Chamber at 24°C, fixed diet), 14(Chamber at 19°C, fixed diet) or 18(Chamber at 19°C, fixed diet), and 21(Chamber at 24°C, fasting)', 'description': 'Plasma FGF-21 (pg/ml)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Core Body Temperature (C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chamber at 19°C With Fixed Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}, {'id': 'OG001', 'title': '2. Chamber at 19°C, ad Libitum Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}], 'classes': [{'title': 'Chamber at 24°C, fixed diet', 'categories': [{'measurements': [{'value': '36.98', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '37.02', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Chamber at 19°C, fixed diet', 'categories': [{'measurements': [{'value': '36.97', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '36.95', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Chamber at 24°C, fasting', 'categories': [{'measurements': [{'value': '36.98', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '36.98', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 6 (Chamber at 24°C, fixed diet), 14(Chamber at 19°C, fixed diet) or 18(Chamber at 19°C, fixed diet), and 21(Chamber at 24°C, fasting)', 'description': 'Core body temperature measured in chamber', 'unitOfMeasure': 'C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Weight Change at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chamber at 19°C With Fixed Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}, {'id': 'OG001', 'title': '2. Chamber at 19°C, ad Libitum Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '8.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Weight change from baseline to 6 months', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Weight Change at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chamber at 19°C With Fixed Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}, {'id': 'OG001', 'title': '2. Chamber at 19°C, ad Libitum Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '8.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Weight change from baseline to 12 months', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chamber at 19°C With Fixed Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}, {'id': 'FG001', 'title': '2. Chamber at 19°C, ad Libitum Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}], 'periods': [{'title': 'Chamber at 24°C, Fixed Diet', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'Chamber at 24°C, ad Libitum Diet', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Chamber at 19°C, Fixed Diet', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'Chamber at 19°C, ad Libitum Diet', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'Chamber at 24°C, Fasting', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Chamber at 19°C With Fixed Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}, {'id': 'BG001', 'title': '2. Chamber at 19°C, ad Libitum Diet First', 'description': "Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.\n\nNormal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C\n\nFixed diet: A diet that matches the participant's caloric needs\n\nAd libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '37.8', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '36.5', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', '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': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-23', 'size': 425784, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-03T15:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07-03', 'completionDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2016-10-19', 'resultsFirstSubmitDate': '2025-06-04', 'studyFirstSubmitQcDate': '2016-10-19', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-23', 'studyFirstPostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24-hour Energy Expenditure (kcal)', 'timeFrame': 'Days 6 (Chamber at 24°C, fixed diet), 10(Chamber at 24°C, ad libitum diet), 14(Chamber at 19°C, fixed or ad libitum diet), 18(Chamber at 19°C, fixed or ad libitum diet), and 21(Chamber at 24°C, fasting)', 'description': 'Energy expenditure (EE) as measured during 24 hours in a whole-room calorimeter'}, {'measure': '24-hour Energy Intake (kcal)', 'timeFrame': 'Days 6 (Chamber at 24°C, fixed diet), 10(Chamber at 24°C, ad libitum diet), 14(Chamber at 19°C, fixed or ad libitum diet), 18(Chamber at 19°C, fixed or ad libitum diet), and 21(Chamber at 24°C, fasting)', 'description': 'Energy intake as measured during 24 hours in a whole-room calorimeter'}], 'secondaryOutcomes': [{'measure': '24- Hour Respiratory Quotient (RQ)', 'timeFrame': 'Days 6 (Chamber at 24°C, fixed diet), 10(Chamber at 24°C, ad libitum diet), 14(Chamber at 19°C, fixed or ad libitum diet), 18(Chamber at 19°C, fixed or ad libitum diet), and 21(Chamber at 24°C, fasting)', 'description': 'RQ, an approximation for the ratio of carbohydrate-to-fat oxidation rates, is measured while in the chamber'}, {'measure': 'Leptin', 'timeFrame': 'Days 6 (Chamber at 24°C, fixed diet), 14(Chamber at 19°C, fixed diet) or 18(Chamber at 19°C, fixed diet), and 21(Chamber at 24°C, fasting)', 'description': 'Plasma leptin (ng/ml)'}, {'measure': 'Secretin', 'timeFrame': 'Days 6 (Chamber at 24°C, fixed diet), 14(Chamber at 19°C, fixed diet) or 18(Chamber at 19°C, fixed diet), and 21(Chamber at 24°C, fasting)', 'description': 'Plasma secretin (ng/ml)'}, {'measure': 'Ghrelin', 'timeFrame': 'Days 6 (Chamber at 24°C, fixed diet), 14(Chamber at 19°C, fixed diet) or 18(Chamber at 19°C, fixed diet), and 21(Chamber at 24°C, fasting)', 'description': 'Plasma grehlin (pg/ml)'}, {'measure': 'FGF-21', 'timeFrame': 'Days 6 (Chamber at 24°C, fixed diet), 14(Chamber at 19°C, fixed diet) or 18(Chamber at 19°C, fixed diet), and 21(Chamber at 24°C, fasting)', 'description': 'Plasma FGF-21 (pg/ml)'}, {'measure': 'Core Body Temperature (C)', 'timeFrame': 'Days 6 (Chamber at 24°C, fixed diet), 14(Chamber at 19°C, fixed diet) or 18(Chamber at 19°C, fixed diet), and 21(Chamber at 24°C, fasting)', 'description': 'Core body temperature measured in chamber'}, {'measure': 'Weight Change at 6 Months', 'timeFrame': '6 months', 'description': 'Weight change from baseline to 6 months'}, {'measure': 'Weight Change at 12 Months', 'timeFrame': '12 months', 'description': 'Weight change from baseline to 12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Energy Intake', 'Energy Expenditure', 'Eating Behavior', 'Cold Exposure', 'Natural History'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '39675563', 'type': 'DERIVED', 'citation': 'Unlu Y, Piaggi P, Stinson EJ, De Baca TC, Rodzevik TL, Walter M, Fry H, Krakoff J, Chang DC. Cold induces increased ad libitum energy intake independent of changes in energy expenditure: a controlled crossover trial in adults. Am J Clin Nutr. 2025 Feb;121(2):293-303. doi: 10.1016/j.ajcnut.2024.12.013. Epub 2024 Dec 14.'}, {'pmid': '32341039', 'type': 'DERIVED', 'citation': 'Hollstein T, Heinitz S, Ando T, Rodzevik TL, Basolo A, Walter M, Chang DC, Krakoff J, Piaggi P. Metabolic Responses to 24-Hour Fasting and Mild Cold Exposure in Overweight Individuals Are Correlated and Accompanied by Changes in FGF21 Concentration. Diabetes. 2020 Jul;69(7):1382-1388. doi: 10.2337/db20-0153. Epub 2020 Apr 27.'}, {'pmid': '32118268', 'type': 'DERIVED', 'citation': 'Hollstein T, Basolo A, Ando T, Votruba SB, Walter M, Krakoff J, Piaggi P. Recharacterizing the Metabolic State of Energy Balance in Thrifty and Spendthrift Phenotypes. J Clin Endocrinol Metab. 2020 May 1;105(5):1375-92. doi: 10.1210/clinem/dgaa098.'}]}, 'descriptionModule': {'briefSummary': "One reason people gain weight is eating more calories from food than what they need for energy over 24 hours. Metabolism is the amount of energy a person uses over 24 hours. Researchers want to study the relationship between changes in metabolism and how much a person eats.\n\nObjectives:\n\nTo see how much food a person eats when the body's temperature is cooled. To study how changes in metabolism may alter the amount of food a person eats.\n\nEligibility:\n\nHealthy people ages 18-55.\n\nDesign:\n\nParticipants will stay at NIH for 20 days.\n\nDuring the first 4 days, participants will have:\n\n* Medical exam\n* Electrocardiogram\n* Blood and urine tests. One blood test includes drinking a sugar solution.\n* DXA body composition scan\n* Questions about foods they like, physical activity, and personal behavior\n* Exercise test on a stationary bicycle\n\nParticipants will spend 24-hour periods in a metabolic chamber. The chamber will be at normal room temperature or cooler.\n\nSome times, participants will eat a diet that matches their daily needs (fixed or eucaloric). Other times, they can eat as much as they wish from a vending machine (ad libitum).\n\nParticipants will have blood and urine collected.\n\nParticipants will swallow an ingestible wireless sensor and wear a small data recorder device.\n\nOn the second to last day, participants will stay in the metabolic chamber but only consume water and non-caffeinated sugar-free beverages.\n\nParticipants will come back for 1-day visits at six months and one year from the first admission. They will have blood and urine tests, and a DXA scan. They will answer questions on physical activity and food habits.", 'detailedDescription': "More than 30% of adults are considered overweight. In general, lifestyle changes (diet and exercise) or current weight loss drugs only lead to about 5 to 10% weight loss. This may be because a person's energy expenditure, aka the number of calories the body uses, leads to hunger and may increase the amount of food a person eats. Cold exposure is known to increase metabolism but it may not lead to weight loss if appetite and the desire for food are also increased. The primary goal of this study is to evaluate whether changing energy expenditure by cool temperature exposure results in changes in food intake. This study will involve a stay on our clinical research unit where we will determine the energy requirements (at 24 degree C) of 68 healthy, adult volunteers without evidence of diabetes. Exposure to cool temperatures (19 degree C) will be used to increase the number of calories a person's body uses in a day. Participants will spend 24 hours in a room that measures energy expenditure while the temperature in the room is turned down, once with a fixed diet (eucaloric) and once with a buffet of food choices (ad libitum). After the fixed diet, volunteers will self-select how much food they wish to eat for one day from a vending machine. Volunteers will also spend one day fasting followed by a day self-selecting their food from the vending machine. Findings from this study will provide knowledge about a possible causal link between energy expenditure and eating behavior. This information may shed light on why many weight loss interventions that increase energy expenditure do not work as well as expected, and may eventually lead to new weight loss approaches and therapies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n* Premenopausal women and men \\<55 years of age\n* Body weight \\<204 kg (\\<450 pounds) and \\>= 36 kg (\\>= 80 pounds)\n* Stable weight (+/-5% within past 6 months) as determined by volunteer report\n* Healthy, as determined by medical history, physical examination, and laboratory tests\n\nEXCLUSION CRITERIA:\n\n* Age \\<18 years\n* Weight greater than or equal to 204 kg (greater than or equal to 450 pounds, maximum weight of the iDXA machine as per manufacturer s manual), or weight \\<36 kg (\\<80 pounds, minimum weight allowed based on the NIH guidelines of blood drawing for research purposes)\n* Use of medications affecting metabolism and appetite in the last three months\n* Expresses unwillingness to consume all food given during the weight maintaining diet portions of the study (e.g., due to strict dietary restrictions including allergies or vegetarian or kosher diet)\n* Current use of tobacco products, marijuana, amphetamines, cocaine, or intravenous drug use\n* Current pregnancy, pregnancy within the past 6 months or lactation\n* History or clinical manifestation of:\n\n * Type 1 and Type 2 diabetes mellitus\n * History of surgery for the treatment of obesity\n * Endocrine disorders, such as Cushing s disease, pituitary disorders, and hypo and hyperthyroidism\n * Pulmonary disorders, including chronic obstructive pulmonary disease\n * Cardiovascular diseases, including coronary heart disease, heart failure, arrhythmias, and peripheral artery disease\n * High blood pressure by sitting blood pressure measurement using an appropriate cuff higher than 140/90 mmHg on two or more occasions, or current antihypertensive therapy\n * Liver disease, including cirrhosis, active hepatitis B or C, and AST or ALT greater than or equal to 2x normal\n * Gastrointestinal disease including Crohn s disease, ulcerative colitis, celiac disease or other malabsorptive disorders\n * Abnormal kidney function (eGFR \\<60 mL/min/1.73m(2))\n * Central nervous system disease, including previous history of cerebrovascular accidents, dementia, neurodegenerative disorders or history of severe head trauma\n * Cancer requiring treatment in the past five years, except for nonmelanoma skin cancers or cancers that have clearly been cured\n * Infectious disease such as active tuberculosis, HIV (by self report), chronic coccidiomycoses or other chronic infections that might influence EE and weight\n * Diagnosis of binge eating disorder, anorexia and major psychiatric disorders based upon the DSM-IV including depression, schizophrenia and psychosis, which may impact the ability of the participant to be in the respiratory chamber for 24 hour time periods\n* Chronic ethanol use (more than 3 drinks/day)'}, 'identificationModule': {'nctId': 'NCT02939404', 'briefTitle': 'Food Intake Response to Short-Term Modifications of Metabolism in Humans', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Energy Intake Response to Short-Term Alterations of Energy Expenditure in Humans', 'orgStudyIdInfo': {'id': '999917004'}, 'secondaryIdInfos': [{'id': '17-DK-N004', 'type': 'OTHER', 'domain': 'NIDDK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1. Chamber at 24C, fixed diet', 'description': 'Chamber at room temperature (24C) with a fixed eucaloric diet', 'interventionNames': ['Other: Normal temperature', 'Other: Fixed diet']}, {'type': 'EXPERIMENTAL', 'label': '2. Chamber at 24C, ad libitum diet', 'description': 'Chamber at room temperature (24C) with an ad libitum diet (self-select how much food they wish to eat)', 'interventionNames': ['Other: Normal temperature', 'Other: Ad libitum diet']}, {'type': 'EXPERIMENTAL', 'label': '3. Chamber at 19C, fixed diet', 'description': 'Chamber at cold temperature (16C) with a fixed eucaloric diet', 'interventionNames': ['Other: Cold exposure', 'Other: Fixed diet']}, {'type': 'EXPERIMENTAL', 'label': '4. Chamber at 19C, ad libitum diet', 'description': 'Chamber at cold temperature (19C) with an ad libitum diet (self-select how much food they wish to eat)', 'interventionNames': ['Other: Cold exposure', 'Other: Ad libitum diet']}, {'type': 'EXPERIMENTAL', 'label': '5. Chamber at 24C, fasting', 'description': 'Chamber at room temperature (24C) fasting while in chamber and 12 hours before', 'interventionNames': ['Other: Normal temperature', 'Other: Fasting']}], 'interventions': [{'name': 'Cold exposure', 'type': 'OTHER', 'description': '23.25 hours inside respiratory chamber with the temperature set to19°C', 'armGroupLabels': ['3. Chamber at 19C, fixed diet', '4. Chamber at 19C, ad libitum diet']}, {'name': 'Normal temperature', 'type': 'OTHER', 'description': '23.25 hours inside respiratory chamber with the temperature set to 24°C', 'armGroupLabels': ['1. Chamber at 24C, fixed diet', '2. Chamber at 24C, ad libitum diet', '5. Chamber at 24C, fasting']}, {'name': 'Fixed diet', 'type': 'OTHER', 'otherNames': ['Eucaloric diet'], 'description': "A diet that matches the participant's caloric needs", 'armGroupLabels': ['1. Chamber at 24C, fixed diet', '3. Chamber at 19C, fixed diet']}, {'name': 'Ad libitum diet', 'type': 'OTHER', 'description': 'Participants can eat as much as they want', 'armGroupLabels': ['2. Chamber at 24C, ad libitum diet', '4. Chamber at 19C, ad libitum diet']}, {'name': 'Fasting', 'type': 'OTHER', 'description': 'Participants do not eat for 12 hours before and 24 hours in chamber', 'armGroupLabels': ['5. Chamber at 24C, fasting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85014', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'NIDDK, Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Douglas Chang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}