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The impact of the macronutrient composition of a nutritional supplement on postprandial skeletal muscle protein synthesis in elderly.


- candidate number10283
- NTR NumberNTR3047
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-aug-2011
- Secondary IDsSpa.1.C/F  Danone Research Centre for specialised nutrition
- Public TitleThe impact of the macronutrient composition of a nutritional supplement on postprandial skeletal muscle protein synthesis in elderly.
- Scientific TitleThe impact of the macronutrient composition of a nutritional supplement on postprandial skeletal muscle protein synthesis in elderly.
- ACRONYMPro-Act
- hypothesisThe protein-rich nutritional supplement increases skeletal muscle protein synthesis in healthy elderly after bolus intake.
- Healt Condition(s) or Problem(s) studiedSarcopenia
- Inclusion criteria1. Age 65 y or older;
2. Male;
3. Healthy OR Sarcopenic;
4. BMI from 20 through 30 kg/m2;
5. Willingness and ability to comply with the protocol;
6 Written informed consent.
- Exclusion criteria1. Indications related to inadequate glycemic control;
2. All co-morbidities interacting with mobility and/or muscle metabolism of the lower limbs;
3. Any (history of) gastrointestinal disease that interferes with GI function;
4. Diabetes Mellitus type I or II;
5. Adherence to a weight loss diet;
6. Use of protein containing or amino acid containing nutritional supplements within one week of study entry;
7. Participation in any regular exercise program focusing on improving skeletal muscle mass;
8. Known allergy to milk and milk products;
9. Known galactosaemia;
10. Blood diseases, use of anticoagulants or allergy for lidocaine, because of muscle biopsy collection.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2011
- planned closingdate21-dec-2012
- Target number of participants60
- InterventionsDuration of intervention: 1 day.
Intervention: Subjects receive one single-bolus of one of the three study products which are a high-protein oral nutritional supplement, an iso-caloric control product and iso-nitrogenous control product.
- Primary outcomeMixed muscle protein fractional synthetic rate (FSR) [%/h].
- Secondary outcome1. Plasma leucine (Leumax [umol/L]; LeuiAUC [umol/(L*min)]);
2. Plasma essential amino acids (EAAmax [umol/L]; EAAiAUC [umol/(L*min)]).
- TimepointsV0 (screening visit) and V1 (study visit).
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESPhD. Janneke Wilde, de
- CONTACT for SCIENTIFIC QUERIESPhD. Janneke Wilde, de
- Sponsor/Initiator Nutricia Research Centre for Specialised Nutrition
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research - Centre for Specialised Nutrition
- PublicationsN/A
- Brief summaryTo obtain more insight in the preferred macronutrient composition of an oral nutritional supplement. The amino acid tracer methodology is applied to measure skeletal muscle protein synthesis (FSR) in the fasted state and after bolus intake of 1 of the 3 products.
- Main changes (audit trail)
- RECORD26-aug-2011 - 2-feb-2014


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