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

40 Participants Needed

Trial Summary

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.

What evidence supports the effectiveness of the drug Quercetin for microvascular health?

Citrus bioflavonoids, which are components of Quercetin, have been shown to have cardioprotective effects and powerful antioxidant properties, which may support microvascular health. Additionally, nobiletin, a citrus flavonoid, has demonstrated cardiovascular-protective effects, suggesting potential benefits for microvascular health. ^{1 2 3 4 5}

Is quercetin safe for human use?

The research provided does not contain specific safety data for quercetin in humans, so it's important to consult with a healthcare provider for personalized advice. ^{1 6 7 8 9}

What makes the drug Quercetin unique for microvascular health?

Quercetin is unique for microvascular health because it not only improves heart function and blood flow by protecting the structure of blood vessels, but it also has antioxidant and anti-inflammatory properties that help reduce damage and inflammation in the body. This combination of effects makes it different from other treatments that may not address these multiple aspects of vascular health. ^{10 11 12 13 14}

What is the purpose of this trial?

The goal of this study is to learn how a supplement Quercetin can affect microvascular function. Participants will: * give two blood draws of 5 mL each * have a camera placed under the tongue to take pictures of blood vessels * have 2 laser Doppler microdialysis catheters placed on the forearm to monitor blood vessels before and after local drug infusion Researchers will compare blood vessel function of those who take estrogen supplements to those who do not.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Citrus Flavanones Enhance β-Carotene Uptake in Vitro Experiment Using Caco-2 Cell: Structure-Activity Relationship and Molecular Mechanisms. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Citrus flavonoid 5-demethylnobiletin suppresses scavenger receptor expression in THP-1 cells and alters lipid homeostasis in HepG2 liver cells. [2017]

3. Germany pubmed.ncbi.nlm.nih.gov

Transcriptomics, molecular docking, and cross-resistance profiling of nobiletin in cancer cells and synergistic interaction with doxorubicin upon SOX5 transfection. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Analysis of Citrus Bioflavonoid Content and Dipeptidyl Peptidase-4 Inhibitory Potential of Commercially Available Supplements. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

The inhibitory effects of 5-hydroxy-3,6,7,8,3',4'-hexamethoxyflavone on human colon cancer cells. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of functional stability of quercetin as a raw material and in different topical formulations by its antilipoperoxidative activity. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of functional stability of quercetin as a raw material and in different topical formulations by its antilipoperoxidative activity. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Safety and pharmacokinetics of naringenin: A randomized, controlled, single-ascending-dose clinical trial. [2021]

9. Brazil pubmed.ncbi.nlm.nih.gov

Complete 1H and 13C NMR assignments and anti fungal activity of two 8-hydroxy flavonoids in mixture. [2022]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The cardioprotective action of quercetin in experimental occlusion and reperfusion of the coronary artery in dogs]. [2013]

11. England pubmed.ncbi.nlm.nih.gov

Quercetin and its major metabolites selectively modulate cyclic GMP-dependent relaxations and associated tolerance in pig isolated coronary artery. [2021]

12. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The effect of the 5-lipoxygenase inhibitor quercetin on the functional and morphologic manifestations of myocardial lesions in ischemia and reperfusion of the heart]. [2017]

13. Czech Republic pubmed.ncbi.nlm.nih.gov

Chronic administration of quercetin induces biomechanical and pharmacological remodeling in the rat coronary arteries. [2020]

14. Germany pubmed.ncbi.nlm.nih.gov

Assessment of anti-inflammatory and antioxidant activity of quercetin-rutin blend (SophorOx™) - an invitro cell based assay. [2022]