Effects of High-protein, Leucine-enriched Oral Nutritional Supplement and Resistance Exercise on Physical Performance among Malnourished Older Adults with Sarcopenia
- Conditions
- Eldery with sarcopenia. This study would like to evaluate the effect of protein-enriched formulation supplement and resistance exercise on physical performance.sarcopenia, protein-enriched formulation supplement, resistance exercise, physical performance, 5-time chair stand test
- Registration Number
- TCTR20210421002
- Lead Sponsor
- Thai Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
High-protein, leucine-enriched ONS and RT have benefits for malnourished sarcopenic older adults through improvements in physical performance, muscle strength, muscle mass, recovery rates from malnutrition, frailty, and QoL.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 54
1.Patients of both sexes who are at least 60 years old, 2.Diagnosed as sarcopenia by Asian Working Group for Sarcopenia (AWGS) Low of muscle strength (Hand grip strength) or physical performance (5-time chair stand test), 3.Mini Nutritional Assessment (MNA) up to 24 scores (malnutrition or risk of malnutrition), 4.Able to sit, stand and walk by him/herself, 5.Able to obtain inform consent form patients or his/her legal representative
1.Having history or diagnosed with disease or symptom that disturb clinical study such as Alzheimer's 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 and Musculoskeletal disease that would limit doing resistance exercise., 2.High Sensitivity C-Reactive Protein (hs-CRP) at least 10 mg/L, 3. Diagnosed with chronic disease that disturb clinical study such as advance cancer, terminal disease especitally patients or his/her legal representative don't want to rescue, 4.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, 5.Having history of immunity problems such as HIV and autoimmune disease, 6. Allergic to whey, casein or any other components of study formula, 7.Taking other study investigated product or medical food within 30 days previous joining this study, 8. Not available to assess body composition by BIA example having peacemaker, having metal implant and swelling, 9.Taking vitamin D more than 10,000 IU/day.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Physical performance week 4, 8 and 12 compare with baseline 5-time chair stand test
- Secondary Outcome Measures
Name Time Method