Protein Intake on Muscle Protein Synthesis Overnight

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

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).

Study Overview

• Status: Completed
• Conditions: Protein Synthesis Overnight
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Milk protein

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1000
      • Metabolic Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Milk protein; Study product will provide 25 g of protein to subjects. One single supplement will be taken.	Dietary supplement: Placebo; Product with no protein
Placebo Comparator: Placebo; Placebo (no protein)	Dietary supplement: Milk protein; Study product will provide 25 g of protein to subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle FSR determination	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.	Within 24 hours of product intake

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activation of signaling pathways involved in skeletal muscle protein balance	Activation of signaling pathways involved in skeletal muscle protein balance will be assessed through use of immunohistochemistry	Within 24 hours after product intake
Glucose metabolism	Glucose metabolism will be assessed from circulating concentrations of glucose and insulin.	Within 24 hours after product intake
Plasma amino acid availability	The quantification of Free Amino Acids in Human Plasma will be done by Amino Acid Analyser Biochrome 30.	Within 24 hours after product intake

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)

Publications and helpful links

General Publications

• Karagounis LG, Beaumont M, Donato-Capel L, Godin JP, Kapp AF, Draganidis D, Pinaud S, Vuichoud J, Shevlyakova M, Rade-Kukic K, Breuille D. Ingestion of a Pre-bedtime Protein Containing Beverage Prevents Overnight Induced Negative Whole Body Protein Balance in Healthy Middle-Aged Men: A Randomized Trial. Front Nutr. 2019 Nov 29;6:181. doi: 10.3389/fnut.2019.00181. eCollection 2019.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: January 16, 2014
• First Submitted That Met QC Criteria: January 17, 2014
• First Posted (Estimate): January 20, 2014

Study Record Updates

• Last Update Posted (Estimate): October 29, 2015
• Last Update Submitted That Met QC Criteria: October 27, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: 13.19.MET