Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-11 @ 1:20 PM
Study NCT ID:
NCT02888405
Status:
COMPLETED
Last Update Posted:
2016-09-05
First Post:
2016-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Acute Dietary Changes on Estimates of Body Composition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000076107', 'term': 'Diet, High-Protein Low-Carbohydrate'}, {'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000073600', 'term': 'Diet, High-Protein'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-30', 'studyFirstSubmitDate': '2016-08-19', 'studyFirstSubmitQcDate': '2016-08-30', 'lastUpdatePostDateStruct': {'date': '2016-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dual-energy X-ray Absorptiometry Output', 'timeFrame': '2 days', 'description': 'Measures of lean soft tissue and fat mass obtained from dual-energy x-ray absorptiometry.'}, {'measure': 'Bioelectrical Impedance Analysis Output', 'timeFrame': '2 days', 'description': 'Measures of fat-free mass and fat mass obtained from bioelectrical impedance analysis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Body Composition'], 'conditions': ['Overweight']}, 'descriptionModule': {'briefSummary': 'The present study sought to investigate the effects of acute dietary changes on estimates of body composition. Specifically, the impact of an acute high-carbohydrate diet (9 g/kg body weight of carbohydrate) and an acute very low-carbohydrate diet (1 - 1.5 g/kg body weight of carbohydrate) were examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy\n* Recreationally active (\\>150 min/week of moderate or vigorous physical activity)\n* Pre-menopausal with regularly occurring menstrual cycles over past 6 months (in females only)\n\nExclusion Criteria:\n\n* Failure to meet inclusion criteria\n* Commencement or cessation of taking the dietary supplement creatine within the past month\n* Pregnant or may become pregnant during the study\n* Known or suspected food allergy to any items used in study\n* Presence of medical condition that could reasonably be negatively affected by participation'}, 'identificationModule': {'nctId': 'NCT02888405', 'briefTitle': 'Effects of Acute Dietary Changes on Estimates of Body Composition', 'organization': {'class': 'OTHER', 'fullName': 'Baylor University'}, 'officialTitle': 'Effects of Acute Dietary Changes on Estimates of Body Composition', 'orgStudyIdInfo': {'id': '805223-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-carbohydrate diet', 'description': 'Single day of 9 g/kg body weight consumption of carbohydrate. Isocaloric to very low-carbohydrate condition.', 'interventionNames': ['Other: High-carbohydrate diet']}, {'type': 'EXPERIMENTAL', 'label': 'Very low-carbohydrate diet', 'description': 'Single day of 1 - 1.5 g/kg body weight consumption of carbohydrate. Isocaloric to high-carbohydrate condition.', 'interventionNames': ['Other: Low-carbohydrate diet']}], 'interventions': [{'name': 'High-carbohydrate diet', 'type': 'OTHER', 'armGroupLabels': ['High-carbohydrate diet']}, {'name': 'Low-carbohydrate diet', 'type': 'OTHER', 'armGroupLabels': ['Very low-carbohydrate diet']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}