Pre-frail ElderlyPhase 4NCT02753582
The Effect of SOD Enzyme on Frailty and HRQOL Among Indonesian Pre-frail Elderly: A Double Blind Randomized Controlled Trial
A Phase 4 study testing SOD+Gliadin Capsule in people with Pre-frail Elderly, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Pre-frail Elderly
- What is being tested?
- SOD+Gliadin Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteIndonesia
- Study dates
- Apr 2016to Apr 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly aged 60 years or more with pre-frail condition
- Patients with SOD enzyme deficiency
- Willing to participate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo National Hospital
Jakarta, Jakarta Special Capital Region, 10430
Rahmi Istanti, MARS, 8151974578 ext. +62, r_istanti@hotmail.com
About this study
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
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.
Read the detailed description
- 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).
- Conditions
- Pre-frail Elderly
- Being tested
- SOD+Gliadin Capsule, Placebo
- Keywords
- Elderly, pre-frail, SOD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOD+Gliadin CapsuleDietary supplement
Also called GLISODin
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | SOD+Gliadin capsule is given in a dosage of 250 mg twice a day, for 24 weeks. Receives: Dietary Supplement: SOD+Gliadin Capsule |
| Placebo | Placebo comparator | Placebo capsule is given in a dosage of 250 mg twice a day, for 24 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty status
Measured by FI-40 item questionnaire.
Measured: 6 months (24 weeks)
Secondary outcomes (4)
Health related quality of life
Measured by EQ5D questionnaire.
Measured: 6 months (24 weeks)
Anti-oxidant serum status
Measured by erythrocyte antioxidant enzymes activity, i.e. superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX).
Measured: 6 months (24 weeks)
Morbidity
Measured by Cumulative Illness Rating Score (CIRS).
Measured: 6 months (24 weeks)
Hospitalization
Observed hospitalization event during the study
Measured: 6 months (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionFeb 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Pre-frail ElderlyStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siti Setiati, Universitas Indonesia
- Investigators
- Siti Setiati, Prof, MD, PhD, Study chair, Fakultas Kedokteran Universitas IndonesiaPurwita Wijaya Laksmi, MD, Study director, Fakultas Kedokteran Universitas IndonesiaKuntjoro Harimurti, MD, Principal investigator, Fakultas Kedokteran Universitas IndonesiaRahmi Istanti, MARS, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753582
- Sponsor's protocol ID
- SOD
- Status last verified
- May 2016
- First submitted
- 12 Apr 2016
- Last updated
- 30 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 23245606Rodriguez-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.
PubMed 25468154Clegg 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.
PubMed 23395245Laksmi PW. Frailty syndrome: an emerging geriatric syndrome calling for its potential intervention. Acta Med Indones. 2014 Jul;46(3):173-4. No abstract available.
PubMed 25348178Setiati 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.
PubMed 24448330Setiati S. Vitamin D status among Indonesian elderly women living in institutionalized care units. Acta Med Indones. 2008 Apr;40(2):78-83.
PubMed 19054885Gill 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.
PubMed 16505261Sumantri 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.
PubMed 25348180Wang 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.
PubMed 25506599Kobayashi 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.
PubMed 25389961Cloarec 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.
PubMed 17441415Ensrud 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.
PubMed 18299493Peng 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.
PubMed 24804252Bjelakovic 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.
PubMed 24040282Persson 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.
PubMed 24669288
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02753582
- Acronym / sponsor ID
- SOD
- Conditions
- Pre-frail Elderly
- Keywords
- Elderly, pre-frail, SOD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: SOD+Gliadin CapsuleSOD+Gliadin capsule is given in a dosage of 250 mg twice a day, for 24 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsule is given in a dosage of 250 mg twice a day, for 24 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elderly aged 60 years or more with pre-frail condition
- Patients with SOD enzyme deficiency
- Willing to participate
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOD+Gliadin CapsuleAlso: GLISODin | Dietary supplement | Intervention |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Frailty status
Time frame: 6 months (24 weeks)
Measured by FI-40 item questionnaire.
4 secondary outcomes
Health related quality of life
Time frame: 6 months (24 weeks)
Anti-oxidant serum status
Time frame: 6 months (24 weeks)
Morbidity
Time frame: 6 months (24 weeks)
Hospitalization
Time frame: 6 months (24 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2016.
- Background: PubMed 23245606Salomon 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.
- Background: PubMed 25468154Rodriguez-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.
- Background: PubMed 23395245Clegg 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.
- Background: PubMed 25348178Laksmi PW. Frailty syndrome: an emerging geriatric syndrome calling for its potential intervention. Acta Med Indones. 2014 Jul;46(3):173-4. No abstract available.
- Background: PubMed 24448330Setiati 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.
- Background: PubMed 19054885Setiati S. Vitamin D status among Indonesian elderly women living in institutionalized care units. Acta Med Indones. 2008 Apr;40(2):78-83.
- Background: PubMed 16505261Gill 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.
- Background: PubMed 25348180Sumantri 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.
- Background: PubMed 25506599Wang 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.
- Background: PubMed 25389961Kobayashi 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.
- Background: PubMed 17441415Cloarec 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.
- Background: PubMed 18299493Ensrud 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siti Setiati, Prof, MD, PhD study chair
Fakultas Kedokteran Universitas Indonesia
Purwita Wijaya Laksmi, MD study director
Fakultas Kedokteran Universitas Indonesia
Kuntjoro Harimurti, MD principal investigator
Fakultas Kedokteran Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SOD+Gliadin Capsule in people with Pre-frail Elderly, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siti Setiati, Prof, MD, PhD (8138985588 ext. +62, s_setiati@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty status (time frame: 6 months (24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02753582, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2016.