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Completed

NCT Number: NCT02168218

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

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

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHUV-clinical research center

Lausanne, Canton of Vaud, CH-1011, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

7-day overfeeding

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Lausanne

Other

Collaborators

  • Insel Gruppe AG, University Hospital Bern

Registry information

Official study title

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

Acronym: FruMilk

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 20, 2014
Registry last updated
May 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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