Protein Synthesis Overnight
Conditions
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).
Interventions
DIETARY_SUPPLEMENTMilk protein
Study product will provide 25 g of protein to subjects.
DIETARY_SUPPLEMENTPlacebo
Product with no protein
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
55 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| muscle FSR determination | 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
| Measure | Time frame | Description |
|---|---|---|
| Activation of signaling pathways involved in skeletal muscle protein balance | Within 24 hours after product intake | Activation of signaling pathways involved in skeletal muscle protein balance will be assessed through use of immunohistochemistry |
| Glucose metabolism | Within 24 hours after product intake | Glucose metabolism will be assessed from circulating concentrations of glucose and insulin. |
| Plasma amino acid availability | Within 24 hours after product intake | The quantification of Free Amino Acids in Human Plasma will be done by Amino Acid Analyser Biochrome 30. |
Countries
Switzerland
Outcome results
None listed