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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | SOD+Gliadin capsule is given in a dosage of 250 mg twice a day, for 24 weeks. |
|
| Placebo | Placebo Comparator | Placebo capsule is given in a dosage of 250 mg twice a day, for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOD+Gliadin Capsule | Dietary Supplement |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Frailty status | Measured by FI-40 item questionnaire. | 6 months (24 weeks) |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siti Setiati, Prof, MD, PhD | Contact | 8138985588 | +62 | s_setiati@yahoo.com |
| Purwita Wijaya Laksmi, MD | Contact | 8161390993 | +62 | pwlaksmi@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Siti Setiati, Prof, MD, PhD | Fakultas Kedokteran Universitas Indonesia | Study Chair |
| Purwita Wijaya Laksmi, MD | Fakultas Kedokteran Universitas Indonesia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusumo National Hospital | Recruiting | Jakarta | Jakarta Special Capital Region | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23245606 | Background | 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. | |
| 25468154 | Background | Rodriguez-Manas L, Fried LP. Frailty in the clinical scenario. Lancet. 2015 Feb 14;385(9968):e7-e9. doi: 10.1016/S0140-6736(14)61595-6. Epub 2014 Nov 6. No abstract available. |
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| Dietary Supplement |
|
| 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) |
| Kuntjoro Harimurti, MD |
| Fakultas Kedokteran Universitas Indonesia |
| Principal Investigator |
| Rahmi Istanti, MARS | Fakultas Kedokteran Universitas Indonesia | Principal Investigator |
| 23395245 | Background | 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. |
| 25348178 | Background | Laksmi PW. Frailty syndrome: an emerging geriatric syndrome calling for its potential intervention. Acta Med Indones. 2014 Jul;46(3):173-4. No abstract available. |
| 24448330 | Background | 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. |
| 19054885 | Background | Setiati S. Vitamin D status among Indonesian elderly women living in institutionalized care units. Acta Med Indones. 2008 Apr;40(2):78-83. |
| 16505261 | Background | 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. doi: 10.1001/archinte.166.4.418. |
| 25348180 | Background | 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. |
| 25506599 | Background | 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):1031. |
| 25389961 | Background | 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. |
| 17441415 | Background | 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. |
| 18299493 | Background | 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. |
| 24804252 | Background | 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. |
| 24040282 | Background | 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. |
| 24669288 | Background | 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. |
| 19465742 | Background | 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. |
| 24079768 | Background | Laosa O, Alonso C, Castro M, Rodriguez-Manas L. Pharmaceutical interventions for frailty and sarcopenia. Curr Pharm Des. 2014;20(18):3068-82. doi: 10.2174/13816128113196660705. |