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Completed

NCT Number: NCT02041143

Protein Intake on Muscle Protein Synthesis Overnight

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).

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Key information

Age range

55 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Metabolic Unit

Lausanne, Canton of Vaud, 1000, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Milk protein

Dietary Supplement

Study product will provide 25 g of protein to subjects.

Placebo

Dietary Supplement

Product with no protein

Primary outcomes

  1. muscle FSR determination

    Time frame: Within 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 outcomes

  1. Activation of signaling pathways involved in skeletal muscle protein balance

    Time frame: Within 24 hours after product intake

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

  2. Glucose metabolism

    Time frame: Within 24 hours after product intake

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

  3. Plasma amino acid availability

    Time frame: Within 24 hours after product intake

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

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Effects of Protein Intake on Muscle Protein Synthesis and Whole Body Protein Balance During an Overnight Fast: an Exploratory Study

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 20, 2014
Registry last updated
Oct 29, 2015

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.