Effect of protein-enriched formulation supplement and resistance exercise on physical performance in malnourished elders with sarcopenia

Thai Otsuka Pharmaceutical Co., Ltd. 0 sites54 target enrollmentApril 21, 2021

ConditionsEldery 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

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Eldery with sarcopenia. This study would like to evaluate the effect of protein-enriched formulation supplement and resistance exercise on physical performance.
Sponsor: Thai Otsuka Pharmaceutical Co., Ltd.
Enrollment: 54
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

who.int

Start Date

April 21, 2021

End Date

October 20, 2022

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

Thai Otsuka Pharmaceutical Co., Ltd.

Eligibility 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

•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.