Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-03-05 @ 7:36 AM
Study NCT ID:
NCT02168218
Status:
COMPLETED
Last Update Posted:
2018-05-04
First Post:
2014-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Milk Proteins on Protein Synthesis in Healthy Male Subjects Fed a Hypercaloric, High Sucrose Diet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-01', 'studyFirstSubmitDate': '2014-06-05', 'studyFirstSubmitQcDate': '2014-06-16', 'lastUpdatePostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'whole body protein synthesis', 'timeFrame': 'after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet', 'description': 'Whole body protein synthesis, protein turnover, and protein oxidation will be calculated using 13C-labelled leucine infusion in both fasted and fed conditions'}], 'secondaryOutcomes': [{'measure': 'intrahepatic and intramuscular fat concentration', 'timeFrame': 'after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet', 'description': 'Intrahepatic and intramuscular fat concentration will be measured by in-vivo 1H-Magnetic Resonance Spectroscopy'}, {'measure': 'Energy expenditure', 'timeFrame': 'after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet', 'description': 'Energy expenditure will be measured by indirect calorimetry min fasted and fed conditions'}, {'measure': 'Metabolic variables in plasma samples', 'timeFrame': 'after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet', 'description': 'Plasma glucose, insulin, nonesterified fatty acids, triglycerides, VLDL-triglycerides, insulin, glucagon GH, IGF1, IGFBP1, 2 and 3 will be measured in fasted and fed conditions'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['protein synthesis', 'intrahepatic fat', 'lean body mass', 'IGF1', 'energy metabolism'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This study aims at assessing the hypothesis that dietary protein content is a major factor regulating lean body mass gain and energy expenditure during overfeeding, and thus long term body weight gain\n\nTo test this hypothesis, healthy normal weight male and female subjects will before and after a 7-day hypercaloric, high-sucrose diet (+40% excess energy as sucrose) and either a low (5% total energy) or a high (20% total energy) protein intake. Each subject will be studied with both low- and high protein diets according to a randomized, crossover study. On each occasion the following measurements will be done in basal conditions (after 2-day isoenergetic, controled diet) and at the end of the 7-day overfeeding:\n\n* whole-body protein turnover, oxidation and synthesis in fasting conditions and fed conditions (13C-labelled leucine)\n* intrahepatic and intramuscular fat concentration (1H-Magnetic Resonance Spectroscopy)\n* Energy metabolism in fasted and fed conditions (indirect calorimetry)\n* plasma concentration of glucose, non-esterified fatty acids, total triglyceride, very-low density lipoprotein (VLDL)-triglyceride, insulin, glucagon, growth hormone (GH), insulin-like growth factor 1 (IGF1), insulin-like growth factor binding protein (IGFBP) 1,2 and 3 in fasting and fed conditions The effects of high-protein and low-protein sucrose overfeeding on whole body protein synthesis will be compared using two-way ANOVA; relationships between changes in whole body protein synthesis on one hand, and intrahepatic/intramuscular fat concentrations, total energy expenditure, and plasma concentration of metabolic variables on the other hand, will be evaluated by linear regression analysis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* good apparent health\n* low physical activity\n* non-smokers\n\nExclusion Criteria:\n\n* vegans or following any special diet\n* consumption of \\> 3 dl/day sweetened beverages\n* changes in body \\> +/- 3Kg over the past 3 months\n* contra-indications to magnetic resonance spectroscopy\n* drug or substance abuse\n* consumption \\> 10g/day alcohol\n* lactose intolerance'}, 'identificationModule': {'nctId': 'NCT02168218', 'acronym': 'FruMilk', 'briefTitle': 'Effects of Milk Proteins on Protein Synthesis in Healthy Male Subjects Fed a Hypercaloric, High Sucrose Diet', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne'}, 'officialTitle': 'Effects of Milk Proteins on Whole Body Protein Synthesis and Ectopic Lipid Deposition During Sucrose Overfeeding in Healthy Male Subjects', 'orgStudyIdInfo': {'id': '218/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high protein', 'description': '20% protein diet', 'interventionNames': ['Other: 7-day overfeeding']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'low protein', 'description': '7.5% protein diet', 'interventionNames': ['Other: 7-day overfeeding']}], 'interventions': [{'name': '7-day overfeeding', 'type': 'OTHER', 'description': '7-day overfeeding with an excess sucrose intake corresponding to 40% total energy requirements', 'armGroupLabels': ['high protein', 'low protein']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'CHUV-clinical research center', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Luc Tappy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Lausanne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lausanne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Physiology', 'investigatorFullName': 'Luc Tappy, MD', 'investigatorAffiliation': 'University of Lausanne'}}}}