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
Conditions
Interventions
subjected will be taken investigated product twice daily and exercised 4 times per week (physical therapist will follow up and give an advise at least once a month)
Experimental Dietary Supplement
protein-enriched formulation supplement and resistance exercise
Sponsors
Thai Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Age
60 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical performance week 4, 8 and 12 compare with baseline 5-time chair stand test | — |
Secondary
| Measure | Time frame |
|---|---|
| Muscle mass, fat mass week 4, 8, 12 compare with baseline BIA,Muscle mass, fat mass week 12 compare with baseline DXA,Hand grip strength week 4, 8, 12 compare with baseline Jamar hand grip dynamometer,The Short Physical Performance Battery week 4, 8, 12 compare with baseline Balance test, Gait speed test, chair stand test,Health-related quality of life week 12 compare with baseline SarQoL,Frail questionnaire week 12 compare with baseline FRAIL SCALE,Activity of Daily Living week 12 compare with baseline Thai Barthel Activities of Daily Living,Body weight week 4, 8, 12 compare with baseline Body weighing scale,Energy and protein intake week 4, 8, 12 compare with baseline INMUCAL-Nutrients program,Blood Biochemical Profile (BUN, creatinine, GFR, albumin, electrolyte) week 12 compare with baseline laboratory test,Plasma level of vitamin B12, vitamin D, homocysteine, PTH week 12 compare with baseline laboratory test, Nutrition status week 4, 8, 12 compare with baseline albumin, total lymphocyte count laboratory testing and Mini Nutritional Assessment score,Gastrointestinal adverse effects such as vomiting, diarrhea, constipation and abdominal distention week 4, 8, 12 after baseline Recording of patient telling | — |
Countries
Thailand
Contacts
Public ContactThipwadee Yamchuenpong
Thai Otsuka Pharmaceutical Co., Ltd
Outcome results
None listed