Porvoo Sarcopenia & Nutrition Trial

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2012
INTERVENTION: 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. CONDITION: Age related muscle loss i.e. sarcopenia PRIMARY OUTCOME: Changes in muscle health according to hand grip strength (Bohannan 2008), habitual 4‐meter gait speed (Guralnik et al. 1994, Nieves et al. 2005), balance (Guralnik et al. 1994, Nieves et al. 2005), chair stand test power (Takai et al. 2009), and 2‐minute step test (Rikli & Jones 1999). Changes in physical performance according to short physical performance battery (Guralnik et al. 1994) and continuous summary physical performance scores (Nieves et al. 2005). SECONDARY OUTCOME: Changes in body composition according to body mass index and direct segmental bioimpedance spectroscopy measurements (Yamada et al. 2010, Bjorkman et al. 2012). Changes in cognition according to Mini Mental State Examination (Folstein et al. 1975), verbal fluency (Welsh et al. 1991) and clock drawing test (Sunderland et al. 1989), and clinical dementia rating sum of boxes (Hughes et al. 1982). Changes in health related quality of life according to SF/RAND‐36 (Hays et al. 1993) and 15D (Sintonen 2001) patient questionnaires. Changes in nutrition according to Mini Nutritional Assessment (Guigoz et al. 2002), diet quality questionnaire (Makela & Laitinen 2012), and dietary records (Suominen et al. 2007) Compliance to supplementation and home based exercises according to patient diaries. Mortality according National Census records Number of falls according to simple patient questionnaires and medical record data. Patient reported benefits and adverse effects according to patient interview. The expected adverse effects are different gastrointestinal symptoms. No severe adverse effects are expected. Serum and plasma markers of inflammation, anabolism, glycemic control and renal function. Blood samples are deep frozen for later analyses and details on methods are a matter of availability of funds. Use of health care (number of hospitalization/follow‐up time) and social services (number of institutionalization/follow‐up time) according to patient records 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.
Epistemonikos ID: a58912adb236fdc32209694666840fbb7fe13b77
First added on: Aug 25, 2024