Genistein for the Reduction of Adverse Cardiovascular Events (GRACE)

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• age: 19-80
• males and females
• all ethnicities
• no history of cardiovascular disease
• HIV positive participants (30 volunteers, experimental group)
• HIV positive participants (30 volunteers, control group)

🚫 You may not be able to join if…

• if HIV positive: detectable viral load or CD4<350
• use cannabis containing only cannabidiol (CBD)
• ingest oral tetrahydrocannabinol (THC)
• unable to provide a receipt for the cannabis product(s)they ingest
• consume soy products, genistein, isoflavonoids, and/or resveratrol
• pregnant
• breastfeeding
• endometriosis
• uterine fibroids
• have cancer (breast cancer, predisposition to cancer such as abnormal mammogram, family history, BRCA1/BRCA2 positive)
• liver dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)>3X ULN, total bilirubin greater than 1.5 times ULN)
• hormone replacement therapy (HRT)
• thyroid supplements
• renal dysfunction (eGFR less than 25 mL/min/1.73 m2)
• uncontrolled diabetes (HgbA1c>10%)
• coagulopathies
• cytopenia (leukocytopenia, hemoglobin<9 mg/dl, platelets<100x103/mm3)
• upper extremity digits/limbs that prevent adequate vascular function test signal acquisition
• under the effect of vasodilators
• medical conditions which prohibit blood flow occlusion in both arms

+ 1 more criteria — see the full checklist in the app.

Where this trial is running

• London Regional Health Science Centre, London, Ontario, Canada

Who to contact

Mark JK Chandy, MD PhD · 519-661-2111 · mark.chandy@lhsc.on.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07785388.