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

Obesity Clinical Trial

— FruMilk  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02168218
• Other study ID #: 218/13
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: May 2016

Study information

• Verified date: May 2018
• Source: University of Lausanne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• 7-day overfeeding
7-day overfeeding with an excess sucrose intake corresponding to 40% total energy requirements

Locations

Country	Name	City	State
Switzerland	CHUV-clinical research center	Lausanne	VD

Sponsors (2)

Lead Sponsor	Collaborator
University of Lausanne	University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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