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NOT YET RECRUITING
NCT07785388
PHASE1/PHASE2

Genistein for the Reduction of Adverse Cardiovascular Events (GRACE)

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

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-09-30

Completion Date

2028-06-30

Last Updated

2026-08-25

Healthy Volunteers

No

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

Locations (1)

London Regional Health Science Centre

London, Ontario, Canada