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van CCT (UK)

van CCT (UK)

An exploratory study into the acute and long-term effects of high-protein supplementation on postprandial muscle protein metabolism in healthy elderly.

- candidate number12883
- NTR NumberNTR3471
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jun-2012
- Secondary IDsSpa.1.C/G / 2011-A01399-32; Danone Research / CPP
- Public TitleAn exploratory study into the acute and long-term effects of high-protein supplementation on postprandial muscle protein metabolism in healthy elderly.
- Scientific TitleAn exploratory study into the acute and long-term effects of high-protein supplementation on postprandial muscle protein metabolism in healthy elderly.
- ACRONYMPro-Motion
- hypothesisThe protein-rich nutritional supplement increases muscle protein synthesis.
- Healt Condition(s) or Problem(s) studiedSarcopenia
- Inclusion criteria1. Age 65 y or older;
2. Male;
3. BMI from 20 through 30 kg/m2;
4. Willingness and ability to comply with the protocol;
5. Written informed consent.
- Exclusion criteria1. Prior or current participation in any other clinical study using phenylalanine stable isotopes;
2. Indications related to inadequate glycemic control;
3. Co-morbidities:
A. All co-morbidities interacting with mobility and/or muscle metabolism of the lower limbs and hands;
B. Any malignant disease during the last five years except for adequately treated prostate cancer without evidence of metastases, localized bladder cancer, breast cancer in situ or non-melanoma skin cancer;
C. Any (history of) gastrointestinal (GI) disease that interferes with GI function;
D. Known kidney failure;
E. Known liver failure;
F. Moderately severe and severe anaemia;
G. Diabetes Mellitus type I or II;
H. (Chronic) inflammatory status;
I. Any known food allergy to the ingredients of the breakfast consumed during study visits;
J. Dementia: Mini Mental State Examination <25.
4. Medication:
A. Use of oral or systemic antibiotics within 3 weeks prior to study visit;
B. Current oral or systemic use of corticosteroids, testosterone, growth hormone, immunosuppressants, tricyclics, opiates, barbiturates or insulin.
5. Malnutrition:
A. Severe weight loss (>3 kg in the last 3 months);
B. Severe loss of appetite.
6. Dietary or life style characteristics:
A. Adherence to a weight loss diet three months before and during the study;
B. Adherence to a high energy or high protein diet three months before starting and during the study;
C. Use of protein containing or amino acid containing nutritional supplements within one week of study entry and during the study;
D. Participation in a muscle strengthening program three months before starting and during the study;
E. Current or recent (within past 3 months) smoking;
F. Current alcohol or drug abuse in opinion of the investigator.
7. Indications related to the study product:
A. A cumulative monthly dose of more than 140 g (5600 IU) of vitamin D supplementation administrated according to a weekly or monthly regimen during the last three months;
B. More than 5 g (200 IU) of daily vitamin D intake from medical sources (including food supplements and vitamin supplements);
C. More than 500 mg of daily calcium intake from medical sources;
D. Known allergy to milk and milk products;
E. Known galactosaemia.
8. Contraindications related to muscle biopsy procedure:
A. Blood diseases;
B. Use of anticoagulants;
C. Allergy for lidocaine;
D. Prostate hypertrophy (Prostate specific antigen > 4 g/L) ;
E. Glaucoma.
9. Blood donation within 2 months of study entry, during the study and 1 month after study completion;
10. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements;
11. Participation in any other study involving investigational or marketed products concomitantly or within 4 weeks prior to entry into the study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2012
- planned closingdate31-dec-2013
- Target number of participants24
- InterventionsDuration of intervention: 6 weeks.
1. Intervention group: Protein-rich nutritional supplement. One daily serving (200mL) taken before breakfast;
2. Control group: Placebo product. One daily serving (200mL) taken before breakfast.
- Primary outcomeMixed muscle protein fractional synthetic rate (FSR) [%/h].
- Secondary outcome1. Rate of phenylalanine uptake by the forearm [mol/100ml.min];
2. Rate of phenylalanine release by the forearm [mol/100ml.min];
3. Forearm phenylalanine net balance [mol/100ml.min].
- Timepoints0 and 6 weeks.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- 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 investigate the effect of a protein-rich nutritional supplement on parameters for muscle metabolism.
- Main changes (audit trail)
- RECORD11-jun-2012 - 19-nov-2013

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