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

NCT02168218 | Completed

• 1 other identifier: 218/13
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Keywords

protein synthesis; intrahepatic fat; lean body mass; IGF1; energy metabolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• intrahepatic and intramuscular fat concentration

  after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet

• Energy expenditure

  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

  after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet

Study Arms (2)

high protein

EXPERIMENTAL

20% protein diet

Other: 7-day overfeeding

low protein

ACTIVE COMPARATOR

7.5% protein diet

Other: 7-day overfeeding

Interventions

7-day overfeeding OTHER

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

high protein; low protein

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• good apparent health
• low physical activity
• non-smokers

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lausanne: lead
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (1)

CHUV-clinical research center

Lausanne, Canton of Vaud, CH-1011, Switzerland

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luc Tappy, MD

  University of Lausanne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physiology

Study Record Dates

• First Submitted: June 5, 2014
• First Posted: June 20, 2014
• Study Start: December 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

CH (1)