No registrations found.
ID
Source
Brief title
Health condition
Sarcopenia
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mixed muscle protein fractional synthetic rate (FSR) [%/h].
Secondary outcome
1. Rate of phenylalanine uptake by the forearm [µmol/100ml.min];
2. Rate of phenylalanine release by the forearm [µmol/100ml.min];
3. Forearm phenylalanine net balance [µmol/100ml.min].
Background summary
To investigate the effect of a protein-rich nutritional supplement on parameters for muscle metabolism.
Study objective
The protein-rich nutritional supplement increases muscle protein synthesis.
Study design
0 and 6 weeks.
Intervention
Duration 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.
Renske Benedictus
Utrecht 3508 TC
The Netherlands
+31 (0)30 2095 000
renske.benedictus@danone.com
Renske Benedictus
Utrecht 3508 TC
The Netherlands
+31 (0)30 2095 000
renske.benedictus@danone.com
Inclusion criteria
1. 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 criteria
1. 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 ìg (5600 IU) of vitamin D supplementation administrated according to a weekly or monthly regimen during the last three months;
B. More than 5 ìg (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 ìg/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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL3324 |
NTR-old | NTR3471 |
Other | Danone Research / CPP : Spa.1.C/G / 2011-A01399-32; |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |