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Protein Intake on Muscle Protein Synthesis Overnight

Phase 1
Completed
Conditions
Protein Synthesis Overnight
Interventions
Dietary Supplement: Placebo
Dietary Supplement: Milk protein
Registration Number
NCT02041143
Lead Sponsor
Société des Produits Nestlé (SPN)
Brief Summary

This trial is an exploratory study in order to determine whether the ingestion of one type of protein (milk protein/CHO/Fat) vs.placebo (CHO/Fat) 2 hours before bed time results in the extension of the post-prandial window of anabolism during the night by increasing whole body protein balance as well as muscle protein fractional synthesis rate (FSR).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
17
Inclusion Criteria
  • Male
  • Healthy as determined by the medical questionnaire and the medical visit including blood sampling
  • 55-65y of age
  • BMI (19.0 - 25.0 kg/ m²)
  • Having signed the consent form
Exclusion Criteria
  • Digestive (intestinal, gastric, hepatic or pancreatic), renal or metabolic disease, as determined by the medical (screening) visit and a blood chemistry analysis (glucose, total cholesterol, LDL, HDL, triglycerides, aspartate transaminase, alanine aminotransferase, gamma glutamyl transpeptidase, C Reactive Protein, creatinin)
  • Heart or other organ disease
  • Arterial hypertension (Systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg)
  • Any clotting trouble (diagnosed by Prothrombin time (PT), activated Partial Thromboplastin Time (aPTT), fibrinogen measures and platelets number (the latter is part of a classical blood cells counting at screening)
  • Any inflammatory disease in the past four weeks
  • Use of specific medications
  • Recent major surgery (3 months)
  • History of major gastro-intestinal surgery (gastric bypass, intestinal resection etc...)
  • History of cancer within the past year
  • Significant weight loss during the last 3 months (5% and more)
  • Food allergies, especially cow milk protein allergies
  • Special diets especially vegetarian, high protein or weight loss program (anamnesis)
  • Smokers
  • High level structured exercise 3 times a week (e.g.: fitness club, competitions...)
  • Have a high alcohol consumption (more than 2 drinks/day)
  • Consumption of illicit drugs anamnesis only
  • Having given blood within the last month, or willing to make a blood donation until one month following the end of the study
  • Subject who cannot be expected to comply with the study procedures, including consuming the test products.
  • Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Milk proteinPlaceboStudy product will provide 25 g of protein to subjects. One single supplement will be taken.
PlaceboMilk proteinPlacebo (no protein)
Primary Outcome Measures
NameTimeMethod
muscle FSR determinationWithin 24 hours of product intake

Muscle protein FSR (fractional synthesis rate) will be determined using primed constant infusions of \[13C6\] phenylalanine for 5 hours starting around from 03:00 a.m. (see flow chart attached). Whole body protein balance will be measured throughout the night using \[15N\]glycine (200mg) which will be orally taken with the trial product in the evening.

Secondary Outcome Measures
NameTimeMethod
Activation of signaling pathways involved in skeletal muscle protein balanceWithin 24 hours after product intake

Activation of signaling pathways involved in skeletal muscle protein balance will be assessed through use of immunohistochemistry

Glucose metabolismWithin 24 hours after product intake

Glucose metabolism will be assessed from circulating concentrations of glucose and insulin.

Plasma amino acid availabilityWithin 24 hours after product intake

The quantification of Free Amino Acids in Human Plasma will be done by Amino Acid Analyser Biochrome 30.

Trial Locations

Locations (1)

Metabolic Unit

🇨🇭

Lausanne, Vaud, Switzerland

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