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

NCT ID: NCT02168218

Last Updated: 2018-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

high protein

20% protein diet

Group Type: EXPERIMENTAL

7-day overfeeding

Intervention Type: OTHER

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

low protein

7.5% protein diet

Group Type: ACTIVE_COMPARATOR

7-day overfeeding

Intervention Type: OTHER

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

Interventions

7-day overfeeding

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: collaborator

University of Lausanne

OTHER

Sponsor Role: lead

Responsible Party

Luc Tappy, MD

Professor of Physiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luc Tappy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne

Locations

CHUV-clinical research center

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

218/13

Identifier Type: -

Identifier Source: org_study_id