Clinical trial NCT02168218: Effects of Milk Proteins on Protein Synthesis in Healthy Male Subjects Fed a Hypercaloric, High Sucrose Diet
Official title: Effects of Milk Proteins on Whole Body Protein Synthesis and Ectopic Lipid Deposition During Sucrose Overfeeding in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: protein synthesis
intrahepatic fat
lean body mass
IGF1
energy metabolism
Lead sponsor: University of Lausanne
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
First posted: 2014-06-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
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
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
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
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV-clinical research center
state: VD
Study officials:
affiliation: University of Lausanne
name: Luc Tappy, MD
role: PRINCIPAL_INVESTIGATOR
References: