NCT07785388Not yet recruitingPhase 1/2
Genistein for the Reduction of Adverse Cardiovascular Events (GRACE)
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 21 Aug 2026
- Start date
- 30 Sept 2026
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Diseases
- HIV
- NCT number
- NCT07785388
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 60
- From 30 Sept 2026 to the primary completion date, 31 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- hormone replacement therapy (HRT)
Other illness
- 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
Lab values
- 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)
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Regional Health Science Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.