Sarcopenia
Conditions
Interventions
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.
Sponsors
Danone Research – Centre for Specialised Nutrition
Eligibility
Inclusion criteria
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
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 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Mixed muscle protein fractional synthetic rate (FSR) [%/h]. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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]. | — |
Contacts
Public ContactRenske Benedictus
P.O. Box 80141
Outcome results
None listed