Elderly with sarcopenia. This study would like to evaluate the effect of high protein formulation supplement and resistance exercise on physical performance. sarcopenia, high protein formulation supplement, resistance exercise, physical performance, 5-time chair stand test
Conditions
Interventions
Medical food: standard formula,Medical food: high protein formula,Medical food: high protein formula and exercise
Sponsors
None listed
Eligibility
Sex/Gender
All
Age
60 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Patients of both sexes who are at least 60 years old and able to obtain inform consent form patients or his/her legal representative 2. Diagnosed as sarcopenia by Asian Working Group for Sarcopenia (AWGS) 3. Mini Nutritional Assessment (MNA) up to 24 scores (malnutrition or risk of malnutrition) 4. Protein intake 0.5-1 g/kg/day 5. BMI less than 30 kg/m2 6. Able to sit, stand and walk by him/herself
Exclusion criteria
Exclusion criteria: 1. Having history or diagnosed with disease or symptom that disturb clinical study such as Dementia disease, Thyroid disease, Chronic liver disease (at least Class C of Child Pugh Score), chronic kidney disease (GFR up to 30ml/min/1.73m2 ), Myocardial infarction (recovered within 6 months), Unstable angina, Musculoskeletal disease that would limit doing resistance exercise and chronic disease that disturb clinical study such as advance cancer, terminal disease especitally patients or his/her legal representative don't want to rescue. 2. High Sensitivity C-Reactive Protein (hs-CRP) at least 10 mg/L 3. Having history of radiation therapy or chemotherapy within 3 months especially chemotherapy which suppress bone marrow, on immune suppressant (including prednisolone more than 10 mg/day) at least 4 consecutive day in 4 months before join this study. 4. Having history of immunity problems such as HIV and autoimmune disease. 5. Allergic to whey, casein or any other components of study formula 6. Taking other study investigated product or medical food within 30 days previous joining this study. 7. Not available to assess body composition by BIA example having peacemaker, having metal implant and swelling. 8. Taking vitamin D more than 10,000 IU/day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical performance in week 4, 8 and 12 at 12 weeks after end of the intervention 5-time chair stand test | — |
Secondary
| Measure | Time frame |
|---|---|
| Muscle mass, fat mass at 12 weeks after end of the intervention bioelectrical impedance analysis (BIA),Physical activity at 12 weeks after end of the intervention Short Physical Performance Battery ,Physical activity at 12 weeks after end of the intervention 4m gait speed,Physical activity at 12 weeks after end of the intervention Stair climb power test,To compare the difference in fatigue levels from the stair-walking test. at 12 weeks after end of the intervention Rating of Perceived Exertion (RPE),To compare the differences in leg muscle fatigue levels from stair-walking tests. at 12 weeks after end of the intervention Body part discomfort (scale),Arm muscle strength at 12 weeks after end of the intervention Hand grip strength HGS,Nutrition status at 12 weeks after end of the intervention Mini Nutritional assessment,Quality of life at 12 weeks after end of the intervention Quality of life for sarcopenia (SarQoL) questionnaire ,Assessment of frailty at 12 weeks after end of the intervention Frail Questionnaire,Ability to perform daily routines at 12 weeks after end of the intervention Thai Barthel activities of daily living,Sleep quality at 12 weeks after end of the intervention Richard Campbell Sleep Questionnaire | — |
Countries
Thailand
Contacts
Public ContactThipvadee Yamchuenpong
Thai Otsuka Pharmaceutical Co., Ltd.
Outcome results
None listed