| CTRI Number |
CTRI/2025/04/084284 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of resveratrol on aging among elderly adults |
|
Scientific Title of Study
|
Safety and Effectiveness of Resveratrol in Promoting Sirtuin 1 Activation and Enhancing Health in Elderly Adults: A Prospective Interventional Approach |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Subramaniyan |
| Designation |
Professor |
| Affiliation |
SRM hospital and research centre,SRM IST |
| Address |
H block 1st floor, Room no - 21 Department of General Medicine, SRM hospital and research centre,SRM institute of science and technology, kattankulathur, chengalpattu district, 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9443307525 |
| Fax |
|
| Email |
subramak1@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Melvin George |
| Designation |
Professor |
| Affiliation |
SRM hospital and research centre,SRM IST |
| Address |
D block 3rd floor SRM Centre for Clinical Pharmacology, SRM hospital and research centre,SRM institute of science and technology, kattankulathur, chengalpattu district, 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9080281508 |
| Fax |
|
| Email |
melving@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Subhiksha S |
| Designation |
Student |
| Affiliation |
SRM college of pharmacy, SRM hospital and research centre,SRM IST |
| Address |
J block 4th floor pharmacy practice, SRM college of pharmacy, SRM hospital and research centre,SRM institute of science and technology, kattankulathur, chengalpattu district, 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
6369323824 |
| Fax |
|
| Email |
ss3833@srm.ist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre, General Medicine Outpatient, Potheri, Chengalpattu - 603203 Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL
|
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K Subramaniyan |
SRM Medical College Hospital and Research Centre |
Department of General Medicine Ground floor, B block, OP-3, Room no- B 09, SRM medical college and research center, Kattankulathur Kancheepuram TAMIL NADU
Kancheepuram
TAMIL NADU |
9443307525
subramak1@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRMIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E888||Other specified metabolic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Resveratrol |
Resveratrol 500mg/day for 90 days(3months) |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Men and women of age 60-75 years.
If diabetic, should be on stable oral hypoglycemic medications for at least 3 months.
If hypertensive, on stable anti-hypertensive medications for at least 3 months.
Willing to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
Severe respiratory or cardiac dysfunction.
Abnormally elevated liver enzymes ALT and or AST more than tree times ULN.
eGFR less than thirty ml per min
Elevated creatinine phosphokinase CPK more than three times ULN.
Chronic alcoholic or drug abuse subjects.
Known cases of malignancy and HIV infection.
Use of antioxidant supplements.
Use of Hormone replacement therapy.
History of significant head injury or any major surgery.
Previous use of resveratrol in the past three months.
Severe cognitive impairment or dementia.
Subject who participated in any other clinical investigation using an experimental drug in the
past three months.
Participants who are not willing to attend treatment schedule regularly |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess then effect of resveratrol on sirtuin 1 during the study period
Gradual recovery from symptoms |
Measurement of sirtuin 1 on day 0, day 45 and day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out the MoCa score improvement
Six-minute Walk test (6MWT)
Quality of life measurement (EuroQol-5D-5L Questionnaire)
To evaluate adverse events during the study period
To evaluate treatment adherence |
Assessment of MoCa score, six-minute walk test, EuroQol 5D 5L Questionnaire on day 0, day 45, day 90 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
SummaryIntroduction
Aging leads to a decline in organ function, contributing to chronic illnesses such as diabetes, Alzheimer’s, and heart disease. Cellular senescence, oxidative stress, and mitochondrial dysfunction accelerate aging. Resveratrol, a polyphenol with antioxidant and anti-inflammatory properties, activates the SIRT1 pathway, potentially improving mitochondrial function and reducing oxidative stress. This study aims to assess whether resveratrol can enhance cognitive function and physical health in elderly adults.
Methodology
- Study Design: Prospective interventional study.
- Inclusion Criteria: Elderly adults (60–75 years), stable diabetic or hypertensive patients, willing to give consent.
- Exclusion Criteria: Severe cardiac or respiratory dysfunction, high liver enzyme levels, chronic alcohol/drug abuse, cognitive impairment, or previous resveratrol use.
- Intervention: 500 mg/day of Resveratrol.
- Assessments:
- Baseline and follow-up assessments at 45 and 90 days.
- SIRT1 expression levels.
- Six-minute walk test (6MWT) for physical capacity.
- Montreal Cognitive Assessment (MoCA) for cognitive function.
- Quality of life (EuroQol-5D-5L).
- Adverse event monitoring.
Need for Study
With increasing elderly populations, research on safe anti-aging interventions is crucial. Resveratrol has shown promising results in improving mitochondrial function, reducing inflammation, and potentially mitigating age-related diseases. This study aims to provide evidence of its effectiveness in real-world clinical settings.
Procedure
- Screening & Enrollment: Participants are selected based on inclusion and exclusion criteria.
- Baseline Assessment: Demographics, SIRT1 levels, 6MWT, MoCA, and quality of life scores are recorded.
- Intervention: Daily 500 mg resveratrol supplementation with adherence monitoring.
- Follow-ups (Day 45 & 90): Reassessment of key parameters and adverse event reporting.
- Statistical Analysis: Paired t-test to compare changes in key outcomes.
|