None listed
Conditions
Interventions
Intervention1: 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
Sponsors
ACTREC Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -Presence of chronic inflammatory diseases or severe infection. -Severe liver or renal disease. -Known allergies to Resveratrol, copper. -Those with major psychiatric disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| -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. Timepoint: 24 months | — |
Countries
India
Contacts
Public ContactDr Indraneel Mittra
Advance Centre for Treatment Research and Education in Cancer Tata Memorial Centre
Outcome results
None listed