| CTRI Number |
CTRI/2025/09/095427 [Registered on: 26/09/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Resveratrol-Copper Supplementation and its impact on Healthy Adults Aged 70-75 |
|
Scientific Title of Study
|
To assess the effects of Resveratrol-Copper Supplementation on inflammatory cytokines and general wellbeing in healthy individuals aged 70-75 years: an Open Label, Single Arm study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol version 3.0 dated 10/06/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Indraneel Mittra |
| Designation |
Professor Emeritus |
| Affiliation |
Advance Centre for Treatment Research and Education in Cancer Tata Memorial Centre |
| Address |
Department translational Research lab ACTREC
3rd floor room no 307 PS building Sector 22 Utsav Chowk CISF Rd Owe Camp Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9769769720 |
| Fax |
|
| Email |
indraneelmittra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indraneel Mittra |
| Designation |
Professor Emeritus |
| Affiliation |
Advance Centre for Treatment Research and Education in Cancer Tata Memorial Centre |
| Address |
Department translational Research lab ACTREC
3rd floor room no 307 PS building Sector 22 Utsav Chowk CISF Rd Owe Camp Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9769769720 |
| Fax |
|
| Email |
indraneelmittra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indraneel Mittra |
| Designation |
Professor Emeritus |
| Affiliation |
Advance Centre for Treatment Research and Education in Cancer Tata Memorial Centre |
| Address |
Department translational Research lab ACTREC
3rd floor room no 307 PS building Sector 22 Utsav Chowk CISF Rd Owe Camp Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9769769720 |
| Fax |
|
| Email |
indraneelmittra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural funding Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Tata Memorial Centre
Plot No. 1& 2, Sector 22
Kharghar, Navi Mumbai - 410210.
Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
ACTREC Tata Memorial Centre |
| Address |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Tata Memorial Centre
Plot No. 1& 2, Sector 22
Kharghar, Navi Mumbai - 410210.
Maharashtra, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Indraneel Mittra |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Tata Memorial Centre |
Department translational Research lab
3rd floor room no 307 PS building Plot No. 1& 2, Sector 22 Kharghar, Navi Mumbai - 410210.Maharashtra, India.
Raigarh
MAHARASHTRA |
9769769720
indraneelmittra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Centre Advanced Centre for Treatment, Research and Education in Cancer Institutional Ethics Committee (TMC-IEC III) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adults (Male or Female) aged 70-75 years Adults (Male or Female) aged 70-75 years.
The individuals should be ostensibly healthy, defined by the absence of any known illnesses.
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Resveratrol-Copper (R-Cu) |
Dosage R-Cu tablet 1 twice a day on empty stomach.
Route of Administration Per Oral
Treatment Duration: 6 months (24 weeks)
Drug diary will be dispensed for compliance check
Participants will be instructed to return any unused study medication at the end of the study period for accountability purposes.
If a participant misses a dose, they will be instructed to take the missed dose as soon as they remember, but never double the dose.
|
|
|
Inclusion Criteria
|
| Age From |
70.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
-The individuals should be ostensibly healthy, defined by the absence of any known illnesses.
-Volunteers who are normotensives or with well-controlled hypertension. Well controlled HTN is defined as subjects having blood pressure under 140/90 on not more than three anti-hypertensive agents. (Average of three recordings of blood pressure taken in sitting position 10 minutes apart will be considered).
-Volunteers who are euglycemic or with well-controlled diabetes. Well controlled diabetes is defined as HbA1c less than or equal to 6.5 percent pre-diabetic range on not more than three oral hypoglycaemic agents. Patients requiring insulin or GLP1 analogues or any other parenteral anti-diabetic medicine should be stable on a given dose for at least 4 weeks.
-Volunteers with normal lipid profile defined as total cholesterol and LDL levels not more than borderline high with or without hypolipidemic drugs
-Able to provide written informed consent.
-No current use of immunosuppressive medications or treatments that influence. inflammatory or immune responses in the 4 weeks preceding enrolment into the study
|
|
| ExclusionCriteria |
| Details |
-Presence of chronic inflammatory diseases or severe infection.
-Severe liver or renal disease.
-Known allergies to Resveratrol, copper.
-Those with major psychiatric disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The composite primary endpoint will include 10% change from baseline in at least one of the following Biochemical Markers after 6 months of Resveratrol-Copper supplementation:
-C-Reactive Protein
-Glycosylated Haemoglobin (HbA1c)
-Total Cholesterol
|
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Changes in Cytokine Profiles to assess the modulation of systemic inflammation.
-Changes in Immune Cell Frequencies to evaluate the effect of RCU on immune cell modulation.
-Changes in cfChPs levels in circulation
-To assess effect RCU on Liver function, Renal functions and cognitive status.
|
24 months |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
27/10/2025 |
| 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="2"
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
|
As we age, our bodies experience increased
inflammation, reduced metabolic activity, and weakened immune systems, all of
which can contribute to health issues such as heart disease, diabetes, and
memory problems. The nutraceuticals resveratrol (R) and copper (Cu) are
recognised for their potential health benefits; however, their combined effects
in older adults remain largely unknown.
The purpose of
this study is to determine whether resveratrol-copper (R-Cu) supplements can
help ostensibly healthy people in the 70-75 age range by lowering inflammation,
increasing metabolism, and improving general health. To find out whether this
combination helps, we will be administering the R-Cu over period of 6 month and
monitor the effects on key health indicators like blood sugar, cholesterol, and
inflammatory cytokines. We will also monitor the effects of R-Cu on the immune
system, and liver, kidneys and cognitive functions. The goal is to see if this
supplement can help older adults stay healthier and prevent age-related
diseases. |