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Genistein for the Reduction of Adverse Cardiovascular Events (GRACE)

Not Yet RecruitingPhase 1, Phase 2

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

Conditions: HIV, Vascular Disease, Inflammation, Pain Management

Interventions: Genistein (Unconjugated Isoflavones 100), Placebo

Countries: Canada

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 overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

London, Ontario, Canada