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

University of Indonesia (UI)

Status and phase: Unknown; Phase 4

Conditions: Pre-frail Elderly

Treatments: Dietary Supplement: Placebo; Dietary Supplement: SOD+Gliadin Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT02753582

SOD

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 150 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

SOD+Gliadin capsule is given in a dosage of 250 mg twice a day, for 24 weeks.

Treatment:

Dietary Supplement: SOD+Gliadin Capsule

Placebo

Placebo Comparator group

Description:

Placebo capsule is given in a dosage of 250 mg twice a day, for 24 weeks.

Treatment:

Dietary Supplement: Placebo