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

Study Overview
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Brief Summary
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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: SOD enzyme can improve frailty status and health related quality of life among Indonesian pre-frail elderly. SOD enzyme can increase anti-oxidant serum status among Indonesian pre-frail elderly. SOD enzyme can decrease morbidity among Indonesian pre-frail elderly. SOD enzyme can decrease hospitalization events among Indonesian pre-frail elderly.

Detailed Description
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Study design: randomized double blind placebo controlled trial. 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. Study subject: elderly outpatient (aged 60 years old or more) with pre-frail status, who visit the clinic for medical consultation. Data sampling: consecutive method. Sample size: 150 subjects (75 control group, 75 intervention group). 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. 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).

Official Title
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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

Conditions
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Pre-frail Elderly

Intervention / Treatment
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* Dietary Supplement: SOD+Gliadin Capsule
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>SOD+Gliadin capsule is given in a dosage of 250 mg twice a day, for 24 weeks. | Dietary Supplement: SOD+Gliadin Capsule<br> <br> * Other names: GLISODin;|
| Placebo Comparator: Placebo<br>Placebo capsule is given in a dosage of 250 mg twice a day, for 24 weeks. | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frailty status | Measured by FI-40 item questionnaire. | 6 months (24 weeks) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, pre-frail, SOD