None listed
Conditions
Brief summary
Age related muscle loss i.e. sarcopenia is a common health problem among older people and physical exercise and dietary protein has been emphasized in prevention and treatment of sarcopenia. Rigorous trials investigating effects of protein supplementation on physical performance in sarcopenic populations are still scarce. The aim of this study is to investigate the effects of protein supplementation along with simple home-based exercises on physical performance among home-dwelling sarcopenic older people. During 2012 the entire 75+ population (N = 3275) living in Porvoo, Finland will be approached by a postal questionnaire and persons at risk of sarcopenia are further screened for this randomized controlled trial.
Interventions
Arm 1. standard treatment and no supplementation for 12 months
Arm 2. standard treatment and milk protein supplementation of 20 grams (50% whey) twice a day for 12 months. The protein supplementation will be given in a form of 250 ml x 2 strawberry flavoured beverage and it contains 70 kcal/100ml of energy.
Arm 3. standard treatment and isocaloric placebo supplementation twice a day for 12 months. The isocaloric placebo supplementation will be given in a form of 250 ml x 2 strawberry flavoured
Arm 1. standard treatment and no supplementation for 12 months Arm 2. standard treatment and milk protein supplementation of 20 grams (50% whey) twice a day for 12 months. The protein supplementation will be given in a form of 250 ml x 2 strawberry flavoured beverage and it contains 70 kcal/100ml of energy. Arm 3. standard treatment and isocaloric placebo supplementation twice a day for 12 months. The isocaloric placebo supplementation will be given in a form of 250 ml x 2 strawberry flavoured beverage and it contains 1 g/100ml milk proteins (20% whey) and 70 kcal/100ml of energy. Standard treatment will include: a) instructions to perform twice a day 10-30 min home based unsupervised simple exercises (chair rise, steps, etc.), b) instructions to eat proteins on every meal from different protein sources of regular foods, and c) instructions to use vitamin D3 supplementation with a dose of 20 ug/d. The compliance to all treatments is up to the participants themselves and the compliance is followed by daily written patient diaries that are collected every three months.
Sponsors
University of Helsinki
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
75 years or older, living permanently at home in Porvoo, Finland low hand grip strength (men < 30.0 kg, women < 20.0 kg) or slow habitual gait speed (< 0,80 m/s) low skeletal muscle index (2 standard deviations below young adults) measured by direct segmental calf bioimpedance spectroscopy. voluntary participation, written informed consent to participate in study by participant or her/his closest proxy.
Exclusion criteria
not living at home not able to walk indoors independently (canes and walkers allowed) not able to co-operate with hand grip, walking speed, and bioimpedance measurements plasma creatinine > 150 µmol/l terminal illness (estimated prognosis > 6 months) cardiac pacemaker bilateral replacement arthroplasty of the knee severe skin lesions in bioimpedance electrode placement sites (dorsal foot, dorsal ankle, lateral knee, dorsal wrist, and dorsal palm)
Outcome results
None listed