Pre-frail Elderly
Conditions
Keywords
Elderly, pre-frail, SOD
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).
Interventions
DIETARY_SUPPLEMENTSOD+Gliadin Capsule
DIETARY_SUPPLEMENTPlacebo
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frailty status | 6 months (24 weeks) | Measured by FI-40 item questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health related quality of life | 6 months (24 weeks) | Measured by EQ5D questionnaire. |
| 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). |
| Hospitalization | 6 months (24 weeks) | Observed hospitalization event during the study |
Countries
Indonesia
Contacts
Primary ContactSiti Setiati, Prof, MD, PhD
Backup ContactPurwita Wijaya Laksmi, MD
Outcome results
None listed