Clinical trial NCT02041143: Protein Intake on Muscle Protein Synthesis Overnight
Official title: Effects of Protein Intake on Muscle Protein Synthesis and Whole Body Protein Balance During an Overnight Fast: an Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Protein Synthesis Overnight
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2014-01-20
Enrollment: 17
Sex: MALE
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: 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

Primary outcomes:
measure: muscle FSR determination
timeFrame: Within 24 hours of product intake
Secondary outcomes:
measure: Activation of signaling pathways involved in skeletal muscle protein balance
timeFrame: Within 24 hours after product intake
measure: Glucose metabolism
timeFrame: Within 24 hours after product intake
measure: Plasma amino acid availability
timeFrame: Within 24 hours after product intake
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Metabolic Unit
state: Vaud
Study officials:
References:
citation: 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.