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

Phase 4

• Conditions: Pre-frail Elderly
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: SOD+Gliadin Capsule

• Registration Number: NCT02753582
• Lead Sponsor: Indonesia University

Brief Summary

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.

Detailed 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).

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-28
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-27
• Last Update Posted: 2016-05-30
• Primary Completion: 2017-02
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo capsule is given in a dosage of 250 mg twice a day, for 24 weeks.
Intervention	SOD+Gliadin Capsule	SOD+Gliadin capsule is given in a dosage of 250 mg twice a day, for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Frailty status	6 months (24 weeks)	Measured by FI-40 item questionnaire.

Secondary Outcome Measures

Name	Time	Method
Anti-oxidant serum status	6 months (24 weeks)	Measured by erythrocyte antioxidant enzymes activity, i.e. superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX).
Morbidity	6 months (24 weeks)	Measured by Cumulative Illness Rating Score (CIRS).
Health related quality of life	6 months (24 weeks)	Measured by EQ5D questionnaire.
Hospitalization	6 months (24 weeks)	Observed hospitalization event during the study

Trial Locations

Locations (1)

Cipto Mangunkusumo National Hospital; 🇮🇩 Jakarta, Indonesia