|- candidate number||5778|
|- NTR Number||NTR1823|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-mei-2009|
|- Secondary IDs||SPA.1.C/A Danone Research – Centre for Specialised Nutrition|
|- Public Title||Skeletal muscle protein synthesis in elderly after bolus intake of oral nutritional supplements.|
|- Scientific Title||Skeletal muscle protein synthesis in elderly after bolus intake of oral nutritional supplements.|
|- hypothesis||A relatively high quantity of dietary protein is needed to stimulate muscle protein synthesis in elderly.|
|- Healt Condition(s) or Problem(s) studied||Healthy elderly |
|- Inclusion criteria||1. Generally healthy male or female;|
2. Ability to walk, sit down, and stand up independently;
3. Age 60 years or older;
4. BMI between 21 and 30 kg/m2.
|- Exclusion criteria||1. Co-morbidities:|
A. Any (history of) gastrointestinal disease that interferes with GI function;
B. Diagnosed and active treatment of Diabetes Mellitus type I or II;
C. History of congestive heart failure, or recent (6 months) hospitalization for heart disease treatment or management (e.g. PTCA, stent, surgery), or myocardial infarction in the past year.
2. Infection or fever in the last 7 days;
A. Use of antibiotics within 3 weeks prior to the study visit;
B. Current use of corticosteroids, growth hormone, or testosterone.
4. Dietary or life style characteristics:
A. Adherence to a weight loss diet;
B. Use of protein containing or amino acid containing nutritional supplements within one week of study entry;
C. Current participation in muscle strengthening program.
5. Contraindications to biopsy procedure:
A. Platelet count (PLT) < 100,000;
B. History of hypo- or hyper-coagulation disorders including use of a coumarin derivative, history of deep venous thrombosis (DVT), or pulmonary embolism (PE) at any point in lifetime;
C. Currently taking anti-thrombotics and cannot stop for 7 days (i.e. medical indication);
D. Allergy to local anaesthetic.
6. Blood hemoglobin < 9.0 g/dL.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||19-mei-2009|
|- planned closingdate||30-jan-2010|
|- Target number of participants||20|
|- Interventions||1. Duration of intervention: 8 hours;|
2. Intervention group: 8 hours;
3. Control group: 8 hours.
|- Primary outcome||Muscle protein synthesis rate.|
|- Secondary outcome||Plasma amino acids, insulin, and glucose levels.|
|- Timepoints||1. V1: screening visit;|
2. V2: intervention visit;
3. FU1: follow-up call (3 days after intervention visit);
4. FU2: follow-up call (5-10 days after intervention visit).
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| R. Memelink|
|- CONTACT for SCIENTIFIC QUERIES||PhD. Y.C. Luiking|
|- Sponsor/Initiator ||Danone Research B.V.|
(Source(s) of Monetary or Material Support)
|Danone Research B.V. |
|- Brief summary||Generally healthy elderly volunteers will be asked to participate in this study, which is designed to examine the effect of protein quantity in an oral nutritional supplement on muscle protein synthesis in elderly. Amino acid tracer methodology is applied to measure muscle protein synthesis in the fasted state and after bolus intake of one of two oral nutritional supplements. Muscle biopsies will be taken at two time points to determine the incorporation of the amino acid tracer in the muscle as a measure of protein synthesis. At various time points blood samples will be taken for analyses of amino acid, glucose and insulin levels.|
|- Main changes (audit trail)|
|- RECORD||19-mei-2009 - 1-dec-2010|