Sarcopenia
Conditions
Interventions
Duration of intervention: 13 weeks with an optional extension period of 13 weeks.
1. Intervention group: All participants in the intervention group will receive daily two servings of the Active study
2. Control group: All participants in the control group will receive daily two servings of the (isocaloric) Control product.
Both products consist of about 40 grams of powder which has to be dissolve
Sponsors
Danone Research - Centre for Specialized Nutrition
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 65 years or older; 2. Performance Score (SPPB) from 4 through 9; 3. Class I or II sarcopenia, measured with bioelectrical impedance assessment (BIA); 4. BMI 20 - 30 kg/m2; 5. Informed consent; 6. Willingness and ability to comply with the protocol.
Exclusion criteria
Exclusion criteria: 1. Any malignant disease during the last five years except for adequately treated prostate cancer without evidence of metastases, localized bladder cancer, cervical carcinoma in situ, breast cancer in situ or non-melanoma skin cancer; 2. Known kidney failure (previous glomerular filtration rate 10 mg/L); 6. Psychiatric disease, i.e.: A. Depression: Geriatric Depression Scale (15 items) >8; B. Schizophrenia symptomatic disease; C. Dementia: Mini Mental State Examination 3 kg in the last 3 months); B. BMI <20 kg/m2; C. Severe loss of appetite. 9. Severe impairments of hand-function that will obstruct reliable grip strength measurements (e.g. rheumatoid arthritis); 10. Dietary or life style characteristics: A. Participation in a weight loss diet three months before starting 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 three months before starting and during the study. 11. Participation in a muscle strengthening program three months before starting and during the study; 12. Current alcohol or drug abuse in opinion of the investigator; 13. Indications related to the study product: A. More than 10 µg (400 IU) of daily Vitamin D intake from medical sources; B. More than 500 mg of daily calcium intake from medical sources. 14. Known allergy to milk and milk products; 15. Known galactosaemia; 16. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements; 17. Participation in any other study involving investigational or marketed products concomitantly or within four weeks prior to entry into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Muscle strength (hand dynamometry) during 13 weeks of intervention; 2. Physical Performance (test battery) during 13 weeks of intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Physical activity (Questionnaire); 2. Appendicular muscle mass (DXA and BIA); 3. Health related quality of life (Questionnaire); 4. Independence of ADL (Questionnaire). | — |
Contacts
Public ContactGerben Hofman
P.O. Box 7005
Outcome results
None listed