Quercetin for Metabolism

Overseen By Loukia Lili, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thorne Research Inc.

Must not be taking: Statins, Lipid-lowering supplements

Disqualifiers: Metabolic syndrome, Hypertension, Diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether quercetin, a natural compound in many fruits and vegetables, can improve metabolic health. Participants will take a special form of quercetin for 90 days to observe its effects on cholesterol, blood sugar, and overall metabolic function. Ideal participants have slightly high LDL cholesterol and meet at least two other criteria, such as a specific waist size. The study requires maintaining consistent lifestyle habits and includes blood tests at the start and end. As an unphased trial, this study offers an opportunity to contribute to scientific understanding and potentially enhance metabolic health.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not take any lipid-lowering medications or supplements, including statins, quercetin, and others listed, during the study. If you are currently taking these, you would need to stop before participating.

What prior data suggests that quercetin is safe for human use?

Research shows that quercetin, a natural substance in many fruits and vegetables, has been safely used as a dietary supplement for a long time. Studies have found that quercetin can help lower blood pressure and cholesterol, benefiting heart health. It also acts as an antioxidant, protecting the body from harmful molecules.

Quercetin is generally well-tolerated. Some individuals have reported side effects like headaches or tingling in the arms and legs, but these are uncommon. In animal studies, very high doses caused problems, but humans typically consume much smaller amounts. Overall, quercetin is considered safe when taken in typical dietary supplement doses, making it suitable for most people to try in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care treatments for metabolic health, which often include lifestyle changes and medications like metformin, Quercetin Phytosome is derived from a natural compound found in fruits and vegetables. Researchers are excited about Quercetin because it acts as an antioxidant with potential anti-inflammatory properties, which might offer a more holistic approach to improving metabolic health. Additionally, the phytosome formulation enhances the body's ability to absorb quercetin efficiently, potentially leading to more effective results. This unique mechanism of action and improved bioavailability make Quercetin Phytosome an intriguing option for those seeking alternatives to conventional metabolic health treatments.

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

Studies have shown that quercetin offers many health benefits, such as reducing inflammation and acting as an antioxidant. It can help lower blood pressure and cholesterol levels, which are important for heart health. Quercetin also boosts the immune system and may protect against infections. Some research suggests that it might help with conditions like rheumatoid arthritis and other autoimmune diseases. These benefits indicate that quercetin could improve metabolic health, including blood sugar levels and overall body function. In this trial, all participants will receive Quercetin Phytosome to evaluate its effects further. ^{1 2 5 6 7}

Who Is on the Research Team?

Stephen Phipps, ND, PhD

Principal Investigator

Thorne HealthTech, Inc

Loukia Lili, PhD

Principal Investigator

Thorne HealthTech, Inc

Are You a Good Fit for This Trial?

Inclusion Criteria

Willing and able to comply with the study schedule (+/- 2 days)

Willing and able to travel to a Quest location for both blood draws

Willing and able to fast (except water) for 12 hours prior to each blood draw

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Baseline Assessment

Participants complete an online questionnaire to collect baseline data about lifestyle factors and schedule their first blood draw

1 week

1 visit (in-person for blood draw)

Treatment

Participants take Quercetin Phytosome (250 mg) three times per day with meals for 90 days

12 weeks

Bi-weekly online questionnaires

Final Assessment

Participants complete a final questionnaire and a second blood draw to assess the effects of quercetin supplementation

1 day

1 visit (in-person for blood draw)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Quercetin

How Is the Trial Designed?

Group I: Quercetin Phytosome Experimental Treatment 1 Intervention

All participants will receive Quercetin Phytosome

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?

Thorne Research Inc.

Lead Sponsor

Trials

11

Recruited

450+

Thorne HealthTech, Inc

Lead Sponsor

Trials

11

Recruited

450+

Indena S.p.A

Industry Sponsor

Trials

10

Recruited

570+

Published Research Related to This Trial

Isolated quercetin, commonly taken as a dietary supplement in doses up to 1000 mg per day, has shown a good safety profile in human studies, with only mild adverse effects reported.

However, there is a lack of long-term safety data for high doses of quercetin (≥1000 mg) beyond 12 weeks, and animal studies suggest potential risks such as enhancing kidney toxicity and promoting tumor development in certain cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Aspects of the Use of Quercetin as a Dietary Supplement. Andres, S., Pevny, S., Ziegenhagen, R., et al.[2019]

Quercetin Phytosome® does not affect the bleeding time in patients taking common antiplatelet medications like acetylsalicylic acid, ticlopidine, or clopidogrel, indicating it is safe to use alongside these drugs.

The supplement also does not alter INR levels in patients on anticoagulants like warfarin or dabigatran, nor does it impact blood sugar control in diabetic patients on metformin, suggesting it has a low risk of interaction with these therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interaction study between antiplatelet agents, anticoagulants, diabetic therapy and a novel delivery form of quercetin. Riva, A., Corti, A., Belcaro, G., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10384403/

Recent Advances in Potential Health Benefits of Quercetin Quercetin has cardiovascular benefits such as lowering blood pressure, reducing cholesterol levels, and improving endothelial function.

2. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2021.689044/full

Potential Implications of Quercetin in Autoimmune Diseases Quercetin has reportedly attenuated rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, and systemic lupus erythematosus in humans or animal ...

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

Quercetin – Uses, Side Effects, and More Learn more about Quercetin uses, effectiveness, possible side effects, interactions, dosage, user ratings and products that contain Quercetin.

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

Quercetin as a Therapeutic Product: Evaluation of Its ... Quercetin has antioxidant, anti-inflammatory, cardioprotective, antiviral, and antibacterial effects. It is found to be beneficial against cardiovascular ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2590257125000057

Anti-inflammatory potential of quercetin: From chemistry ... Flavonoids exhibit potent anti-inflammatory, antioxidative, anticancer, and antiviral properties. •. Quercetin modulates inflammation by regulating ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10143896/

Quercetin as a Dietary Supplementary Flavonoid Alleviates ... Quercetin as a dietary supplement can act efficiently as an antioxidant to counteract the oxidative stress induced by lead toxicity.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0753332216311349

Acute, 28 days sub acute and genotoxic profiling of ... Quercetin-Magnesium complex showed mortality at a dose of 185 mg/kg in the Swiss albino mice. In 28 days repeated oral toxicity study, Quercetin-Magnesium ...