Protein Intake on Muscle Protein Synthesis Overnight

Study Overview
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Brief Summary
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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).

Official Title
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Effects of Protein Intake on Muscle Protein Synthesis and Whole Body Protein Balance During an Overnight Fast: an Exploratory Study

Conditions
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Protein Synthesis Overnight

Intervention / Treatment
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* Dietary Supplement: Milk protein
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Milk protein<br>Study product will provide 25 g of protein to subjects. One single supplement will be taken. | Dietary Supplement: Placebo<br>* Product with no protein<br>|
| Placebo Comparator: Placebo<br>Placebo (no protein) | Dietary Supplement: Milk protein<br>* Study product will provide 25 g of protein to subjects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Glucose metabolism | Glucose metabolism will be assessed from circulating concentrations of glucose and insulin. | Within 24 hours after product intake | 
| 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 |