NCT02753582

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. 1.SOD enzyme can improve frailty status and health related quality of life among Indonesian pre-frail elderly.
  2. 2.SOD enzyme can increase anti-oxidant serum status among Indonesian pre-frail elderly.
  3. 3.SOD enzyme can decrease morbidity among Indonesian pre-frail elderly.
  4. 4.SOD enzyme can decrease hospitalization events among Indonesian pre-frail elderly.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 30, 2016

Status Verified

May 1, 2016

Enrollment Period

10 months

First QC Date

April 12, 2016

Last Update Submit

May 27, 2016

Conditions

Pre-frail Elderly

Keywords

Elderly, pre-frail, SOD

Outcome Measures

Primary Outcomes (1)

  • Frailty status

    Measured by FI-40 item questionnaire.

    6 months (24 weeks)

Secondary Outcomes (4)

  • Health related quality of life

    6 months (24 weeks)

  • Anti-oxidant serum status

    6 months (24 weeks)

  • Morbidity

    6 months (24 weeks)

  • Hospitalization

    6 months (24 weeks)

Study Arms (2)

Intervention

ACTIVE COMPARATOR

SOD+Gliadin capsule is given in a dosage of 250 mg twice a day, for 24 weeks.

Dietary Supplement: SOD+Gliadin Capsule

Placebo

PLACEBO COMPARATOR

Placebo capsule is given in a dosage of 250 mg twice a day, for 24 weeks.

Dietary Supplement: Placebo

Interventions

SOD+Gliadin CapsuleDIETARY_SUPPLEMENT
Also known as: GLISODin
Intervention
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly aged 60 years or more with pre-frail condition
  • Patients with SOD enzyme deficiency
  • Willing to participate

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo National Hospital

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

RECRUITING

Related Publications (17)

  • 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.

    PMID: 23245606BACKGROUND

  • 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.

    PMID: 25468154BACKGROUND

  • 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.

    PMID: 23395245BACKGROUND

  • 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.

    PMID: 25348178BACKGROUND

  • 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.

    PMID: 24448330BACKGROUND

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

    PMID: 19054885BACKGROUND

  • 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.

    PMID: 16505261BACKGROUND

  • 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.

    PMID: 25348180BACKGROUND

  • 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.

    PMID: 25506599BACKGROUND

  • 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.

    PMID: 25389961BACKGROUND

  • 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.

    PMID: 17441415BACKGROUND

  • 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.

    PMID: 18299493BACKGROUND

  • 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.

    PMID: 24804252BACKGROUND

  • 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.

    PMID: 24040282BACKGROUND

  • 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.

    PMID: 24669288BACKGROUND

  • 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.

    PMID: 19465742BACKGROUND

  • 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.

    PMID: 24079768BACKGROUND

Study Officials

  • Siti Setiati, Prof, MD, PhD

    Fakultas Kedokteran Universitas Indonesia

    STUDY CHAIR

  • Purwita Wijaya Laksmi, MD

    Fakultas Kedokteran Universitas Indonesia

    STUDY DIRECTOR

  • Kuntjoro Harimurti, MD

    Fakultas Kedokteran Universitas Indonesia

    PRINCIPAL INVESTIGATOR

  • Rahmi Istanti, MARS

    Fakultas Kedokteran Universitas Indonesia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Siti Setiati, Prof, MD, PhD

CONTACT

8138985588s_setiati@yahoo.com

Purwita Wijaya Laksmi, MD

CONTACT

8161390993pwlaksmi@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. MD, PhD

Study Record Dates

First Submitted

April 12, 2016

First Posted

April 28, 2016

Study Start

April 1, 2016

Primary Completion

February 1, 2017

Study Completion

April 1, 2017

Last Updated

May 30, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)