Protein Synthesis Overnight Clinical Trial
Official title:
Effects of Protein Intake on Muscle Protein Synthesis and Whole Body Protein Balance During an Overnight Fast: an Exploratory Study
| Verified date | October 2015 |
| Source | Nestlé |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Ethikkommission |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 17 |
| Est. completion date | May 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 55 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Metabolic Unit | Lausanne | Vaud |
| Lead Sponsor | Collaborator |
|---|---|
| Nestlé |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | Glucose metabolism | Glucose metabolism will be assessed from circulating concentrations of glucose and insulin. | Within 24 hours after product intake | No |
| Secondary | 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 | No |