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

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

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: 7-day overfeeding

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • VD
    • Lausanne, VD, Switzerland, CH-1011
      • CHUV-clinical research center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: high protein; 20% protein diet	Other: 7-day overfeeding; 7-day overfeeding with an excess sucrose intake corresponding to 40% total energy requirements
ACTIVE_COMPARATOR: low protein; 7.5% protein diet	Other: 7-day overfeeding; 7-day overfeeding with an excess sucrose intake corresponding to 40% total energy requirements

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Lausanne
• Collaborators: University Hospital Inselspital, Berne

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: June 5, 2014
• First Submitted That Met QC Criteria: June 16, 2014
• First Posted (ESTIMATE): June 20, 2014

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: protein synthesis; energy metabolism; IGF1; lean body mass; intrahepatic fat
• Other Study ID Numbers: 218/13