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

Pre-frail Elderly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02753582
• Other study ID #: SOD
• Status: Recruiting
• Phase: Phase 4
• First received: April 12, 2016
• Last updated: May 27, 2016
• Start date: April 2016
• Est. completion date: April 2017

Study information

• Verified date: May 2016
• Source: Indonesia University
• Contact: Siti Setiati, Prof, MD, PhD
• Phone: 8138985588
• Email: s_setiati[@]yahoo.com
• Is FDA regulated: No
• Health authority: Indonesia: Departement Kesehatan (Department of Health)Indonesia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pre-frail Elderly

Intervention

Dietary Supplement:
• SOD+Gliadin Capsule

• Placebo

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo National Hospital	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (17)

Bjelakovic G, Nikolova D, Gluud C. Meta-regression analyses, meta-analyses, and trial sequential analyses of the effects of supplementation with beta-carotene, vitamin A, and vitamin E singly or in different combinations on all-cause mortality: do we have evidence for lack of harm? PLoS One. 2013 Sep 6;8(9):e74558. doi: 10.1371/journal.pone.0074558. eCollection 2013. — View Citation

Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8. Review. Erratum in: Lancet. 2013 Oct 19;382(9901):1328. — View Citation

Cloarec M, Caillard P, Provost JC, Dever JM, Elbeze Y, Zamaria N. GliSODin, a vegetal sod with gliadin, as preventative agent vs. atherosclerosis, as confirmed with carotid ultrasound-B imaging. Eur Ann Allergy Clin Immunol. 2007 Feb;39(2):45-50. — View Citation

Ensrud KE, Ewing SK, Taylor BC, Fink HA, Cawthon PM, Stone KL, Hillier TA, Cauley JA, Hochberg MC, Rodondi N, Tracy JK, Cummings SR. Comparison of 2 frailty indexes for prediction of falls, disability, fractures, and death in older women. Arch Intern Med. 2008 Feb 25;168(4):382-9. doi: 10.1001/archinternmed.2007.113. — View Citation

Flores-Mateo G, Carrillo-Santisteve P, Elosua R, Guallar E, Marrugat J, Bleys J, Covas MI. Antioxidant enzyme activity and coronary heart disease: meta-analyses of observational studies. Am J Epidemiol. 2009 Jul 15;170(2):135-47. doi: 10.1093/aje/kwp112. Epub 2009 May 22. — View Citation

Gill TM, Gahbauer EA, Allore HG, Han L. Transitions between frailty states among community-living older persons. Arch Intern Med. 2006 Feb 27;166(4):418-23. — View Citation

Kobayashi S, Asakura K, Suga H, Sasaki S; Three-generation Study of Women on Diets and Health Study Groups. Inverse association between dietary habits with high total antioxidant capacity and prevalence of frailty among elderly Japanese women: a multicenter cross-sectional study. J Nutr Health Aging. 2014 Nov;18(9):827-39. doi: 10.1007/s12603-014-0478-4. — View Citation

Laksmi PW. Frailty syndrome: an emerging geriatric syndrome calling for its potential intervention. Acta Med Indones. 2014 Jul;46(3):173-4. — View Citation

Laosa O, Alonso C, Castro M, Rodriguez-Manas L. Pharmaceutical interventions for frailty and sarcopenia. Curr Pharm Des. 2014;20(18):3068-82. Review. — View Citation

Peng C, Wang X, Chen J, Jiao R, Wang L, Li YM, Zuo Y, Liu Y, Lei L, Ma KY, Huang Y, Chen ZY. Biology of ageing and role of dietary antioxidants. Biomed Res Int. 2014;2014:831841. doi: 10.1155/2014/831841. Epub 2014 Apr 3. Review. — View Citation

Persson T, Popescu BO, Cedazo-Minguez A. Oxidative stress in Alzheimer's disease: why did antioxidant therapy fail? Oxid Med Cell Longev. 2014;2014:427318. doi: 10.1155/2014/427318. Epub 2014 Jan 5. Review. — View Citation

Rodriguez-Mañas L, Fried LP. Frailty in the clinical scenario. Lancet. 2015 Feb 14;385(9968):e7-9. doi: 10.1016/S0140-6736(14)61595-6. Epub 2014 Nov 6. — View Citation

Salomon JA, Wang H, Freeman MK, Vos T, Flaxman AD, Lopez AD, Murray CJ. Healthy life expectancy for 187 countries, 1990-2010: a systematic analysis for the Global Burden Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2144-62. doi: 10.1016/S0140-6736(12)61690-0. Erratum in: Lancet. 2013 Feb 23;381(9867):628. — View Citation

Setiati S, Harimurti K, Dewiasty E, Istanti R, Mupangati YM, Ngestiningsih D, Purwoko Y, Aryana IS, Kuswardhani RT, Pramantara ID, Apandi M, Dwipa L, Budiningsih F, Dinda R, Widajanti N, Siburian P, Sunarti S, Umar S, Jim E, Junaidi-Ar. Profile of food and nutrient intake among Indonesian elderly population and factors associated with energy intake: a multi-centre study. Acta Med Indones. 2013 Oct;45(4):265-74. — View Citation

Setiati S. Vitamin D status among Indonesian elderly women living in institutionalized care units. Acta Med Indones. 2008 Apr;40(2):78-83. — View Citation

Sumantri S, Setiati S, Purnamasari D, Dewiasty E. Relationship between metformin and frailty syndrome in elderly people with type 2 diabetes. Acta Med Indones. 2014 Jul;46(3):183-8. — View Citation

Wang CP, Lorenzo C, Espinoza SE. Frailty Attenuates the Impact of Metformin on Reducing Mortality in Older Adults with Type 2 Diabetes. J Endocrinol Diabetes Obes. 2014;2(2). pii: 1031. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frailty status	Measured by FI-40 item questionnaire.	6 months (24 weeks)	No
Secondary	Health related quality of life	Measured by EQ5D questionnaire.	6 months (24 weeks)	No
Secondary	Anti-oxidant serum status	Measured by erythrocyte antioxidant enzymes activity, i.e. superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX).	6 months (24 weeks)	No
Secondary	Morbidity	Measured by Cumulative Illness Rating Score (CIRS).	6 months (24 weeks)	No
Secondary	Hospitalization	Observed hospitalization event during the study	6 months (24 weeks)	No