The Effect of SOD Enzyme on Frailty and HRQOL Among Indonesian Pre-frail Elderly: A Double Blind Randomized Controlled Trial

Overview

The primary objective is to determine the effect of SOD enzyme on frailty and health related quality of life among Indonesian pre-frail elderly. The secondary objective is to determine the effect of SOD enzyme on anti-oxidant status, morbidity, and hospitalization among Indonesian pre-frail elderly. The study hypothesis: 1. SOD enzyme can improve frailty status and health related quality of life among Indonesian pre-frail elderly. 2. SOD enzyme can increase anti-oxidant serum status among Indonesian pre-frail elderly. 3. SOD enzyme can decrease morbidity among Indonesian pre-frail elderly. 4. SOD enzyme can decrease hospitalization events among Indonesian pre-frail elderly.

1. Study design: randomized double blind placebo controlled trial. 2. Location and time of study: Geriatric Outpatient Clinic and Internal Medicine Outpatient Clinic in Cipto Mangunkusumo National Hospital Jakarta. Study will be conducted on April 2016 to April 2017. 3. Study subject: elderly outpatient (aged 60 years old or more) with pre-frail status, who visit the clinic for medical consultation. 4. Data sampling: consecutive method. 5. Sample size: 150 subjects (75 control group, 75 intervention group). 6. Data collection: demographic data, frailty status, health related quality of life, anthropometric data, anti-oxidant serum status, hospitalization during intervention, morbidity, nutritional status, food intake, hand grip strength. 7. Intervention: SOD+Gliadin in capsule with a dose of 250 mg twice a day for 24 weeks will be given to intervention group, while placebo group will be given placebo capsule (amylum).

Conditions