Protein Intake on Muscle Protein Synthesis Overnight

NCT ID: NCT02041143

Last Updated: 2015-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-05-31

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).

Conditions

Protein Synthesis Overnight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Milk protein

Study product will provide 25 g of protein to subjects. One single supplement will be taken.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Product with no protein

Placebo

Placebo (no protein)

Group Type: PLACEBO_COMPARATOR

Milk protein

Intervention Type: DIETARY_SUPPLEMENT

Study product will provide 25 g of protein to subjects.

Interventions

Milk protein

Study product will provide 25 g of protein to subjects.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Product with no protein

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Metabolic Unit

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 31850360 (View on PubMed)

Other Identifiers

13.19.MET

Identifier Type: -

Identifier Source: org_study_id