Genistein for the Reduction of Adverse Cardiovascular Events (GRACE)

NCT07785388 · tracked via the Priya Life Science Canada tracker

Sponsor

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

Phase

Phase 1/2

Started

2026-09-30

Last updated

2026-08-25

Condition(s) studied

HIVVascular DiseaseInflammationPain Management

Investigational drug(s) / intervention(s)

Genistein (Unconjugated Isoflavones 100)Placebo

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

Placebo: Placebo: twice a day (1000 mg total) for 12 weeks, followed by a washout for 6 weeks

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * 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 Criteria: * 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 * allergic to genistein or inulin

Primary outcome measure(s)

Investigate whether genistein attenuates HIV-induced inflammation. — weeks 1, 4, 8, 12 and 18.
Blood and urine will be collected at weeks 1 (visit 1, baseline), 4 (visit 2), 8 (visit 3), 12 (visit 4) . The blood samples will be analyzed for inflammatory cytokines and proteins using Olink, SEER and/or NULISA proteomics. Plasma may be sent to Greenstone Biosciences for analysis. Urine will be tested for cannabinoids (THC) and nicotine/cotinine to confirm cannabis and tobacco use, respectively at the UH-LHSCRI Lab.
Investigate whether genistein attenuates HIV-induced vascular dysfunction. — at weeks 1 (visit 1, baseline) and week 12 (visit 4)
An evaluation of vascular function at weeks 1 (visit 1, baseline), 12 (visit 4) will be assessed by either endothelial peripheral arterial tonometry (EndoPAT) or flow-mediated dilation (FMD) to determine if genistein treatment improves vasodilation and constriction or vascular tone.

Trial sites (1)

Facility	City	Region	Status
London Regional Health Science Centre	London	Ontario

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07785388 on ClinicalTrials.gov ↗ ← All trials in Canada