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Genistein for the Reduction of Adverse Cardiovascular Events (GRACE)

NCT07785388 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-25

No results posted yet for this study

Summary

People living with HIV (PLHIV) live longer because of modern HIV medicines, but even with these treatments, their bodies are more inflamed. Long term inflammation increases the risk of heart disease, chronic pain, lung disease, dementia, arthritis, and other infections. Because some anti-inflammatory medicines can cause serious side effects, interact with HIV drugs, or be costly, safer and more affordable treatment options are needed. Genistein is a natural compound found in soy foods. It is considered safe and has been shown to reduce inflammation and improve blood vessel health. This study will test whether genistein can lower inflammation in the blood, improve blood vessel health, and reduce pain in PLHIV.

Conditions

Interventions

DIETARY_SUPPLEMENT

Genistein (Unconjugated Isoflavones 100)

Genistein: 500 mg twice a day (1000 mg total) for 12 weeks, followed by a washout for 6 weeks

DRUG

Placebo

Placebo: twice a day (1000 mg total) for 12 weeks, followed by a washout for 6 weeks

Sponsors & Collaborators

  • Greenstone Biosciences, Inc.

    collaborator INDUSTRY

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Mark JK Chandy, MD PhD · Western University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-03-31
Completion
2028-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07785388 on ClinicalTrials.gov