Genistein, a Soy Compound, for Inflammation and Blood Vessel Health in People With HIV
Tests genistein against placebo for inflammation, blood vessels and pain in people with HIV.
Plain-language title generated from the registry record
Registry title: Genistein for the Reduction of Adverse Cardiovascular Events (GRACE)
Key facts
- Where
- London, CanadaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults living with HIV who have no history of heart or blood vessel disease. It tests genistein against a placebo.
- Age
- 19-80 years (the registry header says 18-80 years).
- Sex
- Men and women can join.
- Disease stage
- HIV-positive with an undetectable viral load and CD4 of 350 or more. No history of cardiovascular disease.
- Earlier treatment
- People cannot join if they use hormone replacement therapy, thyroid supplements, vasodilators, or soy products, genistein, isoflavonoids or resveratrol.
- Biomarker or test result
- HIV positive. Viral load must not be detectable and CD4 must not be below 350.
Main reasons for not taking part
- Detectable viral load or CD4 below 350
- Pregnant or breastfeeding
- Cancer or a predisposition to cancer (such as BRCA1/BRCA2 positive)
- Liver, kidney or blood clotting problems, or uncontrolled diabetes
- Use of cannabis with only CBD, oral THC, or no receipt for the cannabis product
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07785388, who can take part
Where in Canada
- London Regional Health Science CentreLondon, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Trial code
- NCT07785388
- Record updated
- 25 August 2026
- Original description
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.Read full original descriptionShow less
Genistein for the Reduction of Adverse Cardiovascular Events (GRACE)
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.
Inclusion: 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).
Exclusion: hormone replacement therapy (HRT); if HIV positive: detectable viral load or CD4<350; have cancer (breast cancer, predisposition to cancer such as abnormal mammogram, family history, BRCA1/BRCA2 positive); uncontrolled diabetes (HgbA1c>10%); medical conditions which prohibit blood flow occlusion in both arms; allergic to genistein or inulin; liver dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)>3X ULN, total bilirubin greater than 1.5 times ULN); renal dysfunction (eGFR less than 25 mL/min/1.73 m2); cytopenia (leukocytopenia, hemoglobin<9 mg/dl, platelets<100x103/mm3); 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; thyroid supplements; coagulopathies; upper extremity digits/limbs that prevent adequate vascular function test signal acquisition; under the effect of vasodilators.