NCT02041143CompletedPhase 1
Effects of Protein Intake on Muscle Protein Synthesis and Whole Body Protein Balance During an Overnight Fast: an Exploratory Study
Société des Produits Nestlé (SPN)2 sites in 1 country17 target enrollmentStarted: February 1, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- muscle FSR determination
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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)
- •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
Outcomes
Primary Outcomes
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
- Activation of signaling pathways involved in skeletal muscle protein balance(Within 24 hours after product intake)
- Glucose metabolism(Within 24 hours after product intake)
- Plasma amino acid availability(Within 24 hours after product intake)
Investigators
Study Sites (2)
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