Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-25 @ 2:29 PM
Study NCT ID:
NCT04145466
Status:
COMPLETED
Last Update Posted:
2025-01-30
First Post:
2019-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Personalized Nutrition Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059305', 'term': 'Diet, High-Fat'}, {'id': 'D000076107', 'term': 'Diet, High-Protein Low-Carbohydrate'}], 'ancestors': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000073600', 'term': 'Diet, High-Protein'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'christoph.hoechsmann@tum.de', 'phone': '+49 (89) 289 - 24492', 'title': 'Christoph Hoechsmann', 'organization': 'Department of Health and Sport Sciences, TUM School of Medicine and Health, Technical University of Munich'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Fat Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Carbohydrate Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Fat Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 2, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Carbohydrate Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphodema', 'notes': 'Lymphodema diagnosed after a surgery to repair a broken leg. The surgery was in Dec. 2020.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lipedema', 'notes': 'Lipedema and fluid retention. Prior ankle surgery cause of this (before POINTS participation). Weight fluctuating frequently.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalized', 'notes': "Admitted to hospital 3/18/2021 to drain abscess on colon. History of diverticulitis. D/C'd on 03/21/2021 and back home.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'notes': 'Diagnosed with RSV and was hospitalized due to difficulty breathing.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Weight Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fat Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG001', 'title': 'Carbohydrate Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG002', 'title': 'Fat Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG003', 'title': 'Carbohydrate Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.5', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '-5.3', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '-5.1', 'spread': '1.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Weight (kg) at 12 weeks minus weight at baseline (kg)', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent Weight Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fat Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG001', 'title': 'Carbohydrate Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG002', 'title': 'Fat Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG003', 'title': 'Carbohydrate Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.9', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-4.8', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '-5.7', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '-5.7', 'spread': '1.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Weight change (kg) / weight at baseline (kg) \\* 100', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fat Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG001', 'title': 'Carbohydrate Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG002', 'title': 'Fat Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG003', 'title': 'Carbohydrate Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.0', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '1.5', 'groupId': 'OG002'}, {'value': '-4.4', 'spread': '2.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Waist circumference (cm) at 12 weeks minus waist circumference at baseline (cm)', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Food Cravings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fat Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG001', 'title': 'Carbohydrate Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG002', 'title': 'Fat Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG003', 'title': 'Carbohydrate Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Food cravings are assessed via the total score of the 33-item Food Craving Inventory (FCI). The FCI is scaled in a frequency format, assessing the frequency with which an individual experiences a craving for a particular food. All items are scored in the following manner: Never = 1, Rarely = 2, Sometimes = 3, Often = 4, \\& Always = 5. Responses from all 33 items are then averaged to produce a total score (range 1-5). Lower total scores indicate a low frequency of cravings across several food groups including high fat foods, sweets, carbohydrates, fast food fats, and fruits and vegetables while higher total scores indicate a high frequency of cravings across these food groups.\n\nChange in food cravings is calculated as FCI total score at 12 weeks minus FCI total score at baseline.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Fat Preference Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fat Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG001', 'title': 'Carbohydrate Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG002', 'title': 'Fat Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG003', 'title': 'Carbohydrate Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '0.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Preference for high- versus low-fat foods is measured with the 74-item Food Preference Questionnaire (FPQ). Individual items in the FPQ measure the preference for either a high fat food or a low fat food on a 9-point Likert scale with the following anchors: 1 = dislike extremely; 5 = neutral, neither like nor dislike; 9 = like extremely.\n\nThe fat preference index (range: 1/9 - 9) is then calculated as the mean rating for high-fat foods divided by the mean rating for low-fat foods. Values greater than 1.0 reflect a higher fat preference, and values less than 1.0 reflect a lower fat preference.\n\nChange in Fat Preference Index is calculated as Fat Preference Index at 12 weeks minus Fat Preference Index at baseline.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Disinhibition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fat Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG001', 'title': 'Carbohydrate Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG002', 'title': 'Fat Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG003', 'title': 'Carbohydrate Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '0.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': "Score on the Disinhibition subscale (16-items) of the 36-item Three-Factor Eating Questionnaire. Items are scored as 'true'=1 or 'false'=0. The Disinhibition score (range: 1-16) is calculated as a sum score of all items within that subscale such that low scores indicate more inhibition while higher scores indicate more disinhibition\n\nChange in Disinhibition is calculated as the score on the Disinhibition subscale at 12 weeks minus the score on the Disinhibition subscale at baseline.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Hunger', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fat Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG001', 'title': 'Carbohydrate Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG002', 'title': 'Fat Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG003', 'title': 'Carbohydrate Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '0.8', 'spread': '0.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': "Score on the Hunger subscale (14 items) of the 36-item Three-Factor Eating Questionnaire. Items are scored as 'true'=1 or 'false'=0. The Hunger score (range: 1-14) is calculated as a sum score of all items within that subscale such that low scores indicate a lower tendency to be hungry while higher scores indicate a greater tendency to be hungry.\n\nChange in Hunger is calculated as the score on the Hunger subscale at 12 weeks minus the score on the Hunger subscale at baseline.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Cognitive Restraint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fat Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG001', 'title': 'Carbohydrate Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG002', 'title': 'Fat Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'OG003', 'title': 'Carbohydrate Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '3.4', 'spread': '1.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': "Score on the Cognitive Restraint subscale (21 items) of the 36-item Three-Factor Eating Questionnaire. Items are scored as 'true'=1 or 'false'=0. The Cognitive Restraint score (range: 1-21) is calculated as a sum score of all items within that subscale such that low scores indicate less cognitive restraint while higher scores indicate greater cognitive restraint.\n\nChange in Cognitive Restraint is calculated as the score on the Cognitive Restraint subscale at 12 weeks minus the score on the Cognitive Restraint subscale at baseline", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fat Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'FG001', 'title': 'Carbohydrate Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'FG002', 'title': 'Fat Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'FG003', 'title': 'Carbohydrate Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '49'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '122', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Fat Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'BG001', 'title': 'Carbohydrate Responders (1)', 'description': 'receiving high-fat diet\n\nHigh-fat diet: The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'BG002', 'title': 'Fat Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'BG003', 'title': 'Carbohydrate Responders (2)', 'description': 'receiving high-carbohydrate diet\n\nHigh-carbohydrate diet: The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '49.8', 'spread': '14.1', 'groupId': 'BG001'}, {'value': '54.4', 'spread': '14.2', 'groupId': 'BG002'}, {'value': '52.4', 'spread': '13.0', 'groupId': 'BG003'}, {'value': '54.4', 'spread': '13.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}], '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'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '83', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '94.2', 'spread': '14.0', 'groupId': 'BG000'}, {'value': '95.2', 'spread': '17.6', 'groupId': 'BG001'}, {'value': '93.5', 'spread': '14.4', 'groupId': 'BG002'}, {'value': '95.6', 'spread': '18.1', 'groupId': 'BG003'}, {'value': '94.3', 'spread': '15.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Includes participants that completed the study and were included in the analysis. Of the 129 participants that completed the study, 7 participants were incorrectly genotyped and were not included in the final analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-12', 'size': 321280, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-25T12:39', 'hasProtocol': True}, {'date': '2021-04-19', 'size': 342602, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-10-25T12:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessors will be blind to diet assignment and genotype pattern. Interventionists will be blind to genotype pattern, but not diet type. To enhance external validity, participants will be told if they are carbohydrate or fat responders.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled parallel arm trial with 4 groups over 12 weeks\n\n1. Fat responders receiving a high-fat diet (n=52)\n2. Fat responders receiving a high-carbohydrate diet (n=52)\n3. Carbohydrate responders receiving a high-fat diet (n=25)\n4. Carbohydrate responders receiving a high-carbohydrate diet (n=25)\n\nThe total number per group is an estimate. We will not close cells to enroll this exact number per group, and the total number of people enrolled will not exceed 154.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-18', 'studyFirstSubmitDate': '2019-10-28', 'resultsFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2019-10-29', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-18', 'studyFirstPostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight Change', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Weight (kg) at 12 weeks minus weight at baseline (kg)'}, {'measure': 'Percent Weight Change', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Weight change (kg) / weight at baseline (kg) \\* 100'}], 'secondaryOutcomes': [{'measure': 'Change in Waist Circumference', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Waist circumference (cm) at 12 weeks minus waist circumference at baseline (cm)'}, {'measure': 'Change in Food Cravings', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Food cravings are assessed via the total score of the 33-item Food Craving Inventory (FCI). The FCI is scaled in a frequency format, assessing the frequency with which an individual experiences a craving for a particular food. All items are scored in the following manner: Never = 1, Rarely = 2, Sometimes = 3, Often = 4, \\& Always = 5. Responses from all 33 items are then averaged to produce a total score (range 1-5). Lower total scores indicate a low frequency of cravings across several food groups including high fat foods, sweets, carbohydrates, fast food fats, and fruits and vegetables while higher total scores indicate a high frequency of cravings across these food groups.\n\nChange in food cravings is calculated as FCI total score at 12 weeks minus FCI total score at baseline.'}, {'measure': 'Change in Fat Preference Index', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Preference for high- versus low-fat foods is measured with the 74-item Food Preference Questionnaire (FPQ). Individual items in the FPQ measure the preference for either a high fat food or a low fat food on a 9-point Likert scale with the following anchors: 1 = dislike extremely; 5 = neutral, neither like nor dislike; 9 = like extremely.\n\nThe fat preference index (range: 1/9 - 9) is then calculated as the mean rating for high-fat foods divided by the mean rating for low-fat foods. Values greater than 1.0 reflect a higher fat preference, and values less than 1.0 reflect a lower fat preference.\n\nChange in Fat Preference Index is calculated as Fat Preference Index at 12 weeks minus Fat Preference Index at baseline.'}, {'measure': 'Change in Disinhibition', 'timeFrame': 'Baseline to 12 weeks', 'description': "Score on the Disinhibition subscale (16-items) of the 36-item Three-Factor Eating Questionnaire. Items are scored as 'true'=1 or 'false'=0. The Disinhibition score (range: 1-16) is calculated as a sum score of all items within that subscale such that low scores indicate more inhibition while higher scores indicate more disinhibition\n\nChange in Disinhibition is calculated as the score on the Disinhibition subscale at 12 weeks minus the score on the Disinhibition subscale at baseline."}, {'measure': 'Change in Hunger', 'timeFrame': 'Baseline to 12 weeks', 'description': "Score on the Hunger subscale (14 items) of the 36-item Three-Factor Eating Questionnaire. Items are scored as 'true'=1 or 'false'=0. The Hunger score (range: 1-14) is calculated as a sum score of all items within that subscale such that low scores indicate a lower tendency to be hungry while higher scores indicate a greater tendency to be hungry.\n\nChange in Hunger is calculated as the score on the Hunger subscale at 12 weeks minus the score on the Hunger subscale at baseline."}, {'measure': 'Change in Cognitive Restraint', 'timeFrame': 'Baseline to 12 weeks', 'description': "Score on the Cognitive Restraint subscale (21 items) of the 36-item Three-Factor Eating Questionnaire. Items are scored as 'true'=1 or 'false'=0. The Cognitive Restraint score (range: 1-21) is calculated as a sum score of all items within that subscale such that low scores indicate less cognitive restraint while higher scores indicate greater cognitive restraint.\n\nChange in Cognitive Restraint is calculated as the score on the Cognitive Restraint subscale at 12 weeks minus the score on the Cognitive Restraint subscale at baseline"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Weight Loss']}, 'referencesModule': {'references': [{'pmid': '37813841', 'type': 'DERIVED', 'citation': 'Hochsmann C, Yang S, Ordovas JM, Dorling JL, Champagne CM, Apolzan JW, Greenway FL, Cardel MI, Foster GD, Martin CK. The Personalized Nutrition Study (POINTS): evaluation of a genetically informed weight loss approach, a Randomized Clinical Trial. Nat Commun. 2023 Oct 9;14(1):6321. doi: 10.1038/s41467-023-41969-1.'}]}, 'descriptionModule': {'briefSummary': "A person's genetic code is believed to affect how much weight he/she will lose during diets that vary in carbohydrate and dietary fat content. 'Carbohydrate responders' are hypothesized to lose more weight on diets that are high in carbohydrates, as compared to high in fats. 'Fat responders' are hypothesized to lose more weight on diets that are high in dietary fat, as compared to high in carbohydrates. The purpose of the proposed study is to test these hypotheses in a randomized controlled trial.", 'detailedDescription': 'Obesity and its comorbidities are major public health challenges. To combat the obesity pandemic, many weight-loss strategies have been studied, often emphasizing either high carbohydrate (low fat) diets or high fat (low carbohydrate) diets. Mean weight loss differences between high-carbohydrate and high-fat diets that induce equal caloric deficits have been reported to be small; however, the individual weight loss response varies substantially within diet groups, suggesting that different individuals react differently to high-carbohydrate or high-fat diets. This assumption is supported by retrospective data showing that participants with carbohydrate-responsive polymorphisms lost 2-3 times more weight when assigned to a high-carbohydrate diet compared to a high-fat diet, and vice versa for those with dietary fat-responsive polymorphisms. Conversely, a recent randomized clinical trial aimed to determine the effect of a healthy high-fat diet (high in unsaturated fats) vs. a healthy high-carbohydrate diet (high in whole-grain foods) on 12-month weight change but did not find significant differences between the two groups and failed to find the hypothesized association between genotype patterns and weight loss induced by diets that varied in fat and carbohydrate content. However, an important caveat of their approach is that the single nucleotide polymorphisms selected by the investigators had not been previously associated with obesity or with dietary responses, which may explain their lack of predictive value in identifying differences in inter-individual responses. In addition, the fat composition of the diets was relatively high in both high- and low-fat groups. The inconsistent findings in the literature indicate a need for further research to determine if genetic factors affect weight loss when exposed to diets that vary in carbohydrates and dietary fats.\n\nThe purpose of this randomized controlled parallel arm trial is to test the following hypotheses.\n\nHypothesis 1 will test if participants assigned to the diet that corresponds to their genotype lose more weight than those assigned to a diet inconsistent with their genotype.\n\nHypothesis 2 will analyze the fat responders and carbohydrate responders separately.\n\n* Hypothesis 2a: Fat responders will lose more weight on the high-fat diet vs. the high-carbohydrate diet.\n* Hypothesis 2b: Carbohydrate responders will lose more weight on the high-carbohydrate diet vs. the high-fat diet.\n\nCarbohydrate responders and fat responders will be randomized to one of the following two diets:\n\n1. A high-quality high-carbohydrate diet that is rich in whole-grain foods, or\n2. A high-quality high-fat diet that is rich in unsaturated fats and oils'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI ≥ 27.0 kg/m2 to \\< 47.5 kg/m2\n* Completed genealogy test and access to the raw data\n* Fat responder or Carbohydrate responder, as determined by genetic risk score\n\nIt is estimated that approximately 1/3 of people are fat responders, 1/3 are carbohydrate responders, and 1/3 are neither or will respond to either diet. Only carbohydrate and fat responders are eligible.\n\nExclusion Criteria:\n\n* Current smoker or has smoked in the previous year\n* For females, pregnant or planned pregnancy during the study duration, or breast-feeding, based on self-report\n* Conditions, diseases, or medications that affect body weight or metabolism (e.g., certain antipsychotic medications; type 2 diabetes mellitus; heart failure; cancer, excluding certain melanomas; etc.)\n* Has gained or lost more than 10 pounds in the last 3 months\n* Currently diagnosed with an eating disorder, major depression, or other condition that, in the judgment of the investigators, could affect the risk to the participant or study completion'}, 'identificationModule': {'nctId': 'NCT04145466', 'acronym': 'POINTS', 'briefTitle': 'The Personalized Nutrition Study', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'The Personalized Nutrition Study: Evaluation of a Genetically-informed Weight Loss Approach', 'orgStudyIdInfo': {'id': 'PBRC 2019-043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fat responders (1)', 'description': 'receiving high-fat diet', 'interventionNames': ['Behavioral: High-fat diet']}, {'type': 'EXPERIMENTAL', 'label': 'Carbohydrate responders (1)', 'description': 'receiving high-fat diet', 'interventionNames': ['Behavioral: High-fat diet']}, {'type': 'EXPERIMENTAL', 'label': 'Fat responders (2)', 'description': 'receiving high-carbohydrate diet', 'interventionNames': ['Behavioral: High-carbohydrate diet']}, {'type': 'EXPERIMENTAL', 'label': 'Carbohydrate responders (2)', 'description': 'receiving high-carbohydrate diet', 'interventionNames': ['Behavioral: High-carbohydrate diet']}], 'interventions': [{'name': 'High-fat diet', 'type': 'BEHAVIORAL', 'description': 'The high-fat diet will consist of \\~40% energy from fat and \\~45% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed', 'armGroupLabels': ['Carbohydrate responders (1)', 'Fat responders (1)']}, {'name': 'High-carbohydrate diet', 'type': 'BEHAVIORAL', 'description': 'The high-carbohydrate diet will consist of \\~20% of energy from fat and \\~65% from carbohydrates. Protein will be 15% of energy.\n\nAll participants will be assigned an energy intake target that will result in a daily deficit of \\~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed', 'armGroupLabels': ['Carbohydrate responders (2)', 'Fat responders (2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70806', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Access to individual de-identified data is possible via Pennington Biomedical Research Center's Data Sharing policy."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'WW International Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Corby K. Martin', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}