Genistein for the Reduction of Adverse Cardiovascular Events (GRACE)

Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study ID
NCT07785388
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • HIV
  • Inflammation
  • Pain Management
  • Vascular Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Genistein (Unconjugated Isoflavones 100) — DIETARY_SUPPLEMENT
    Genistein: 500 mg twice a day (1000 mg total) for 12 weeks, followed by a washout for 6 weeks
  • Placebo — DRUG
    Placebo: twice a day (1000 mg total) for 12 weeks, followed by a washout for 6 weeks

Study Details

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 Dates

First listed
Aug 25, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Mar 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Experimental Group:
    HIV positive experimental group (n=30 participants) will be treated with genistein
  • Placebo Comparator: Control Group
    HIV positive experimental group (n=30 participants) will be treated with placebo

Primary Outcome Measure

Investigate whether genistein attenuates HIV-induced inflammation. [ Time Frame: weeks 1, 4, 8, 12 and 18. ]

Central Contacts

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