|- candidate number||14471|
|- NTR Number||NTR3885|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-mrt-2013|
|- Secondary IDs||NL42489.068.12 / 12-3-058 CCMO / METC|
|- Public Title||Protein feeding prior to sleep as a dietary strategy to improve post-exercise recovery and muscle mass in young and elderly men.|
|- Scientific Title||Protein feeding prior to sleep as a dietary strategy to improve post-exercise recovery and muscle mass in young and elderly men.|
|- hypothesis||Protein feeding prior to sleep improves post-exercise recovery and muscle mass in young and elderly men.|
|- Healt Condition(s) or Problem(s) studied||Sarcopenia, Sport recovery enhancement|
|- Inclusion criteria||1. Males;|
2. Age: Between 18-35 or 65-85 yr;
3. BMI: 18.5-30 kg/m^2;
3. Recreationally active (≥ 1 time/wk).
|- Exclusion criteria||1. Smoking;|
2. Type 2 diabetic;
3. Use of medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medicationsAll co-morbidities (or a history of) interacting with mobility and muscle metabolism of the lower limbs (e.g. artrosis, arthritis, spasticity/rigidity, all neurological disorders and paralysis);
4. Use of anticoagulants, blood diseases, allergy for lidocain;
5. Patients suffering from PKU (Phenylketonuria);
6. Allergies to milk proteins (whey or casein);
8. For the elderly subjects: participation in any strength training program for the last 3
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||8-mrt-2013|
|- planned closingdate||8-jun-2014|
|- Target number of participants||98|
|- Interventions||Elderly subjects are randomized into groups ingesting incremental protein amounts prior to sleep.|
All young subjects perform a bout of resistance exercise before ingesting incremental amounts of protein prior to sleep.
Elderly subjects are randomized into groups ingesting incremental protein amounts prior to sleep (20 gram of protein, 40 gram of protein, 20 gram of protein + 1,5 gram leucine or placebo).
A separate arm is evaluating the effect of resistance exercise and ingestion of 40 gram of protein prior to sleep.
Young subjects are randomized into groups ingesting incremental protein amounts prior to sleep (30 gram of protein, 30 gram of protein + 2 gram of leucine or placebo).
A separate arm is evaluating the effect of ingesting 30 gram of protein prior to sleep.
All experiments will commence at 17:30 and will be finished at 7:30 the next morning.
|- Primary outcome||The primary outcome is muscle protein synthesis fractional synthetic rate (FSR). By taking a muscle biopsy prior to and just after sleep, muscle enrichments of amino acid tracer can be measured and used to calculate rate of muscle protein synthesis (FSR). Amino acid tracers will be provided by intravenous (IV) infusion and by intrinsically–labelled protein. |
|- Secondary outcome||The secondary outcome is amino acid absorption and digestion kinetics. The use of intrinsically labelled protein and blood draws allows us to assess the rate of appearance of the tracer in the plasma as a measurement of amino acid absorption and digestion. |
|- Timepoints||Muscle biopsies for muscle tracer enrichments will be taken just prior to sleep (24:00) and just after sleep (7:00).|
Plasma samples will be taken throughout the night to assess plasma amino acids. In total, 152 ml of blood will be drawn.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Jorn Trommelen|
|- CONTACT for SCIENTIFIC QUERIES|| Jorn Trommelen|
|- Sponsor/Initiator ||TI Food & Nutrition, Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|TI Food and Nutrition|
|- Brief summary||Muscle protein synthesis rates are stimulated during periods of increased plasma amino acid availability. Sleep is a post-absoptive period in which there is decreased plasma amino acid availability. Protein provision prior to sleep may improve overnight muscle protein synthesis rates by increasing plasma amino acid levels. |
|- Main changes (audit trail)|
|- RECORD||7-mrt-2013 - 1-apr-2013|