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

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ClinicalTrials.gov Identifier: NCT02168218
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
Luc Tappy, MD, University of Lausanne

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

Condition or disease Intervention/treatment Phase
Obesity Other: 7-day overfeeding Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Milk Proteins on Whole Body Protein Synthesis and Ectopic Lipid Deposition During Sucrose Overfeeding in Healthy Male Subjects
Study Start Date : December 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose

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




Primary Outcome Measures :
  1. whole body protein synthesis [ Time Frame: after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet ]
    Whole body protein synthesis, protein turnover, and protein oxidation will be calculated using 13C-labelled leucine infusion in both fasted and fed conditions


Secondary Outcome Measures :
  1. intrahepatic and intramuscular fat concentration [ Time Frame: after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet ]
    Intrahepatic and intramuscular fat concentration will be measured by in-vivo 1H-Magnetic Resonance Spectroscopy

  2. Energy expenditure [ Time Frame: after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet ]
    Energy expenditure will be measured by indirect calorimetry min fasted and fed conditions

  3. Metabolic variables in plasma samples [ Time Frame: after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168218


Locations
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Switzerland
CHUV-clinical research center
Lausanne, VD, Switzerland, CH-1011
Sponsors and Collaborators
University of Lausanne
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Luc Tappy, MD University of Lausanne
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Responsible Party: Luc Tappy, MD, Professor of Physiology, University of Lausanne
ClinicalTrials.gov Identifier: NCT02168218    
Other Study ID Numbers: 218/13
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Keywords provided by Luc Tappy, MD, University of Lausanne:
protein synthesis
intrahepatic fat
lean body mass
IGF1
energy metabolism