|- candidate number||17158|
|- NTR Number||NTR4492|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-apr-2014|
|- Secondary IDs||NL47671.068.14 METC Maastricht University|
|- Public Title||Training en eiwit om gezond ouder te worden|
|- Scientific Title||Optimizing the amount of dietary protein to maximally stimulate post-exercise muscle protein synthesis in elderly men|
|- hypothesis||We hypothesize that ingesting 30 g of milk protein will have an optimal effect in stimulating post-exercise muscle protein synthesis when compared to 0, 15 and 45 g milk protein. In addition, we hypothesize that co-ingestion of 1.5 g additional free leucine with 15 g of milk protein will be as effective in stimulating post-exercise muscle protein synthesis compared to 30 g of milk protein.|
|- Healt Condition(s) or Problem(s) studied||Sarcopenia, Muscle protein synthesis, Anabolic resistance|
|- Inclusion criteria||• Healthy males
• Age between 55 and 80 y
• BMI between 18.5 and 30 kg/m2
|- Exclusion criteria||• Celiac disease
• Lactose intolerance
• Cardiovascular Disease
• Donated blood within the last 3 months
• Diagnosed GI tract diseases
• Arthritic conditions
• A history of neuromuscular problems
• Any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).
• Participation in exercise program
• Hypertension, high blood pressure that is above 140/90 mmHg.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2014|
|- planned closingdate||1-mrt-2018|
|- Target number of participants||75|
|- Interventions||Exercise bout and protein drink|
|- Primary outcome||Muscle protein synthesis rates|
|- Secondary outcome||Whole-body protein metabolism and measures of digestion and absorption kinetics|
|- Timepoints||t=0 hrs drink, t=0 and t=6hrs muscle biopsy.
12 blood draws.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||MSc. A. Holwerda|
|- CONTACT for SCIENTIFIC QUERIES||MSc. A. Holwerda|
|- Sponsor/Initiator ||TI Food & Nutrition, Nutrition and Toxicology Research Institute Maastricht (NUTRIM)|
(Source(s) of Monetary or Material Support)
|TI Food and Nutrition|
|- Brief summary||Rationale: The progressive loss of skeletal muscle mass with aging, or sarcopenia, has a major impact on our health care system due to increased morbidity and a greater need for hospitalization and/or institutionalization. It is clearly established that a combination of a resistance exercise program and adequate dietary protein intake are both effective measures to stimulate protein synthesis and counteract sarcopenia. With regards to optimally stimulating muscle protein synthesis, it is also understood that the short time period immediately following a resistance exercise session is the most opportune time to ingest a bolus of dietary protein. What is less understood, however, is the optimal amount of dietary protein that is required to maximize the stimulation of post-exercise muscle protein synthesis in elderly individuals. |
Objective: To identify the amount of dietary protein that will optimally stimulate post-exercise muscle protein synthesis in the older population.
Study design: double-blind, placebo-controlled intervention study
Study population: 60 healthy lean (BMI 18.5-30 kg/m2) older males (age: 55-80 y)
Intervention: A beverage (500 mL) containing milk protein in the amount of 0, 15, 30, 45 g protein or 15 g + 1.5 g leucine (n=12 per group) will be ingested immediately after a single resistance exercise session. The exercise bout will consist of a 5-minute warm-up on a cycle ergometer, followed by 3 sets of chest press and lat pulldown and 4 sets of leg-press and leg-extension. Muscle biopsies will be taken and blood will be drawn at several time points during the day.
Main study parameters/endpoints: Primary study parameters are the rates of muscle protein synthesis. Secondary study parameters include whole-body protein synthesis, breakdown, oxidation, and net balance.
|- Main changes (audit trail)|
|- RECORD||4-apr-2014 - 29-apr-2014|