|- candidate number||8072|
|- NTR Number||NTR2329|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-mei-2010|
|- Secondary IDs||Protocol Spa.1.C/D Danone Research Centre for specialised nutrition|
|- Public Title||Effect of nutritional supplementation on physical performance in elderly.|
|- Scientific Title||Effect of nutritional supplementation on physical performance in elderly.|
|- hypothesis||Dietary management with the medical food under study has a positive effect on muscle strength and physical functioning in elderly.|
|- Healt Condition(s) or Problem(s) studied||Sarcopenia|
|- 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||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 <30 ml/min);
3. Known liver failure;
4. Moderately severe and severe anaemia (Haemoglobin in men <6.5 mmol/l and women <6.0 mmol/l);
5. (Chronic) inflammatory status (CRP level >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 <25.
7. Medication: Antidepressants, Neuroleptics, Corticosteroids for systemic use, immunosuppressants, insulin;
A. Known severe weight loss (>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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2010|
|- planned closingdate||1-sep-2013|
|- Target number of participants||300|
|- 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 product, which has a high protein content;
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 dissolved in 125 ml of water and are available in two flavors: vanilla and strawberry.
During the intervention period, subjects consume two servings per day. In the facultative extension period subjects are randomized into a group consuming one serving and a group consuming two servings per day.
|- Primary outcome||1. Muscle strength (hand dynamometry) during 13 weeks of intervention;|
2. Physical Performance (test battery) during 13 weeks of intervention.
|- Secondary outcome||1. Physical activity (Questionnaire);|
2. Appendicular muscle mass (DXA and BIA);
3. Health related quality of life (Questionnaire);
4. Independence of ADL (Questionnaire).
|- Timepoints||0, 7, 13, and 26 weeks.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MSc. Gerben Hofman|
|- CONTACT for SCIENTIFIC QUERIES||MSc. Sander Wijers|
|- Sponsor/Initiator ||Danone Research B.V.|
(Source(s) of Monetary or Material Support)
|Nutricia Research - Centre for Specialised Nutrition |
|- Brief summary||To investigate the superiority of a specialised Oral Nutritional Supplement (ONS) on muscle strength, physical functioning, QoL, and ADL in elderly vs a control product.|
|- Main changes (audit trail)||8-May-2014: Changes |
Start date (was 30-apr-2010)
End date (was 30-jun-2011)
Status changed into "closed, recruitment complete". - AB
|- RECORD||18-mei-2010 - 8-mei-2014|