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

The Effect of Superoxide Dismutase (SOD) Enzyme on Frailty and Health Related Quality of Life Among Indonesian Pre-frail Elderly: A Double Blind Randomized Controlled Trial

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).

Inclusion Criteria:

• Elderly aged 60 years or more with pre-frail condition
• Patients with SOD enzyme deficiency
• Willing to participate

Exclusion Criteria:

• Patients with cognitive function impairment (AMT score < 8)
• Patients with depression (Geriatric depression scale score >= 10)
• Patients with history of cirrhotic hepatic disease or severe hepatic disease
• Patients with kidney function impairment
• Patients with gluten allergy and derivative products
• Patients consume other antioxidant and omega-3 supplement