Quercetin for Microvascular Health

Overseen By Julia A Vogt

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical College of Wisconsin

Must be taking: Estrogen supplements

Disqualifiers: BMI>60, Hypertension, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the supplement Quercetin can improve the function of small blood vessels. It will compare individuals taking Quercetin to those taking a placebo (a pill with no active ingredient) to assess its effects on blood vessels. The trial seeks participants with obesity, specifically those with a BMI over 30, aged 18 to 40. Participants should be English speakers and must not have certain health conditions, such as high blood pressure or a history of heart attack.

As a Phase 2 trial, this research focuses on measuring Quercetin's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

Is there any evidence suggesting that Quercetin is likely to be safe for humans?

Research has shown that quercetin is generally safe for people. It is a natural substance found in foods like red wine, onions, and apples. Studies have found that quercetin can help reduce inflammation and protect the heart. Although the FDA has not approved quercetin, it is available as a supplement without a prescription.

Regarding safety, reports of serious side effects are rare. People have used quercetin for various health benefits, and it is usually considered safe. Some might experience mild issues like an upset stomach or headache, but these are uncommon.

This trial is in phase 2, indicating that quercetin has already demonstrated some safety in earlier studies. Researchers are now focusing on its effects on blood vessels. Overall, quercetin appears to be a safe choice for those considering joining this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for microvascular health?

Quercetin is unique because it targets microvascular health by enhancing the oxidative capacity of blood vessels. This is different from standard treatments that often focus on managing symptoms or improving blood flow through medication like vasodilators or anticoagulants. Researchers are excited about quercetin because it is a natural, over-the-counter supplement that may improve vascular function in a novel way, potentially offering a more accessible and less invasive option for patients.

What evidence suggests that quercetin might be an effective treatment for microvascular health?

This trial will compare the effects of quercetin with a placebo on microvascular health. Research has shown that quercetin can enhance blood vessel function. It improves the health of the inner lining of blood vessels, potentially leading to lower blood pressure and reduced damage to LDL cholesterol, often called "bad" cholesterol. Studies have found that taking quercetin daily for a month can significantly lower systolic blood pressure. These benefits suggest quercetin could support the health of small blood vessels in the body. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with concerns about microvascular health, which can be related to cardiovascular disease or obesity. Participants will need to provide blood samples and undergo non-invasive imaging of their blood vessels.

Inclusion Criteria

My BMI is over 30.

Exclusion Criteria

Pregnancy or breastfeeding

Resting SBP ≥180 mmHg or DBP ≥ 110mmHg

I have active sores in my mouth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a placebo or quercetin supplement for 30 days to assess microvascular function

4 weeks

Assessment

Participants undergo blood draws, imaging, and microdialysis to measure blood vessel function

2.5 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Quercetin

Trial Overview The study is testing the effects of Quercetin, a dietary supplement, on microvascular function compared to a placebo. It involves monitoring changes in blood vessel function through imaging and laser Doppler microdialysis catheters.

How Is the Trial Designed?

Group I: Use of oral quercetin to improve human microvascular function Experimental Treatment 1 Intervention

Quercetin is a non-FDA approved, over-the-counter supplement that has been shown to improve oxidative capacity in blood vessels.

Group II: Placebo Placebo Group 1 Intervention

A placebo will be administered for 30 days followed by assessment of the subject's microvascular function.

Quercetin is already approved in United States for the following indications:

Approved in United States as Quercetin for:

• Herbal Supplementation
• Nonbacterial Chronic Prostatitis
• Interstitial Cystitis

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10674654/

Quercetin as a Therapeutic Product: Evaluation of Its ... It is found to be beneficial against cardiovascular diseases, cancer, diabetes, neuro-degenerative diseases, allergy asthma, peptic ulcers, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S187853522300343X

A critical review on quercetin bioflavonoid and its derivatives Flavanones have free radical-scavenging properties, which show good health benefits like (YAO et al., 2004) anti-inflammatory action, anti-tumour activity, ...

3. mdpi.com mdpi.com/2072-6643/17/9/1579

The Effects of Quercetin on Vascular Endothelium ... By improving endothelial function, it reduces blood pressure and inhibits the oxidation of low-density lipoprotein (LDL) cholesterol [14]. These effects ...

4. researchgate.net researchgate.net/figure/Chemical-structure-of-quercetin-3-3-4-5-7-pentahydroxyflavone_fig1_326831449

Chemical structure of quercetin (3,3′,4′,5,7- ... We evaluated the effects and mechanisms of quercetin, a flavone identified in a wide variety of dietary sources, in LPS-induced rat intestinal microvascular ...

5. pubs.acs.org pubs.acs.org/doi/10.1021/acsomega.0c01818

Therapeutic Potential of Quercetin: New Insights and ... In a placebo-controlled double-blind study, administration of 730 mg of Que per day for 28 days caused significant reductions in systolic (−7 ± ...

6. webmd.com webmd.com/vitamins/ai/ingredientmono-294/quercetin

Quercetin – Uses, Side Effects, and More Quercetin is a plant pigment (flavonoid). It's found in many plants and foods, such as red wine, onions, green tea, apples, and berries.

7. pubchem.ncbi.nlm.nih.gov pubchem.ncbi.nlm.nih.gov/compound/Quercetin

Quercetin | C15H10O7 | CID 5280343 - PubChem - NIH Quercetin is a pentahydroxyflavone having the five hydroxy groups placed at the 3-, 3'-, 4'-, 5- and 7-positions. It is one of the most abundant flavonoids in ...