Effects of Milk Proteins on Protein Synthesis in Healthy Male Subjects Fed a Hypercaloric, High Sucrose Diet

Study Overview
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Brief Summary
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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 To 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: whole-body protein turnover, oxidation and synthesis in fasting conditions and fed conditions (13C-labelled leucine) intrahepatic and intramuscular fat concentration (1H-Magnetic Resonance Spectroscopy) Energy metabolism in fasted and fed conditions (indirect calorimetry) 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

Official Title
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Effects of Milk Proteins on Whole Body Protein Synthesis and Ectopic Lipid Deposition During Sucrose Overfeeding in Healthy Male Subjects

Conditions
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Obesity

Intervention / Treatment
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* Other: 7-day overfeeding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: good apparent health low physical activity non-smokers Exclusion Criteria: vegans or following any special diet consumption of > 3 dl/day sweetened beverages changes in body > +/- 3Kg over the past 3 months contra-indications to magnetic resonance spectroscopy drug or substance abuse consumption > 10g/day alcohol lactose intolerance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high protein<br>20% protein diet | Other: 7-day overfeeding<br>* 7-day overfeeding with an excess sucrose intake corresponding to 40% total energy requirements<br>|
| Active Comparator: low protein<br>7.5% protein diet | Other: 7-day overfeeding<br>* 7-day overfeeding with an excess sucrose intake corresponding to 40% total energy requirements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whole body protein synthesis | Whole body protein synthesis, protein turnover, and protein oxidation will be calculated using 13C-labelled leucine infusion in both fasted and fed conditions | after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intrahepatic and intramuscular fat concentration | Intrahepatic and intramuscular fat concentration will be measured by in-vivo 1H-Magnetic Resonance Spectroscopy | after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet | 
| Energy expenditure | Energy expenditure will be measured by indirect calorimetry min fasted and fed conditions | after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet | 
| Metabolic variables in plasma samples | 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 | after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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protein synthesis, intrahepatic fat, lean body mass, IGF1, energy metabolism