Effects of Quercetin on Metabolic Health

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

5 Participants Needed

Trial Summary

What is the purpose of this trial?

This Trial will test if quercetin can enhance metabolic health over a few months. Participants will take a special form of quercetin to see if it improves cholesterol, blood sugar, and other health markers. Quercetin has been studied for its potential effects on metabolic health, including improvements in insulin sensitivity, blood pressure, and lipid profiles.

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 evidence supports the effectiveness of the drug Quercetin and its related compounds?

Research shows that quercetin, a key component of this drug, has strong antioxidant and anti-inflammatory properties, which can help in managing conditions like metabolic syndrome and skin disorders. Additionally, combining quercetin with rutin enhances its biological effects, such as reducing inflammation and fighting infections. ^{1 2 3 4 5}

Is quercetin safe for human use?

Quercetin is generally considered safe when used as a dietary supplement, with mild adverse effects rarely reported. However, there is limited data on the long-term safety of high doses, and it may interact with certain drugs or affect people with specific health conditions. ^{4 6 7 8 9}

What makes the drug Quercetin unique compared to other treatments?

Quercetin is unique because it is a natural compound found in citrus fruits and has antioxidant, anti-inflammatory, and potential anticancer properties. Unlike many synthetic drugs, it is derived from natural sources and may offer a broader range of health benefits, including cardiovascular protection and neuroprotection. ^{9 10 11 12 13}

Research Team

Stephen Phipps, ND, PhD

Principal Investigator

Thorne HealthTech, Inc

Loukia Lili, PhD

Principal Investigator

Thorne HealthTech, Inc

Eligibility Criteria

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

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

Treatment Details

Interventions

• Quercetin

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Enriched cereal bars are more effective in increasing plasma quercetin compared with quercetin from powder-filled hard capsules. [2017]

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

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

3. Netherlands pubmed.ncbi.nlm.nih.gov

Liposomes, lipid nanocapsules and smartCrystals®: A comparative study for an effective quercetin delivery to the skin. [2018]

4. Italy pubmed.ncbi.nlm.nih.gov

Interaction study between antiplatelet agents, anticoagulants, diabetic therapy and a novel delivery form of quercetin. [2022]

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

Absorption and urinary excretion of quercetin, rutin, and alphaG-rutin, a water soluble flavonoid, in rats. [2013]

6. Germany pubmed.ncbi.nlm.nih.gov

Safety Aspects of the Use of Quercetin as a Dietary Supplement. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Effect of an antioxidant (quercetin) on sodium-lauryl-sulfate-induced skin irritation. [2019]

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

Toxicological and Genotoxicity Assessment of a Dihydroquercetin-Rich Dahurian Larch Tree (Larix gmelinii Rupr) Extract (Lavitol). [2015]

9. England pubmed.ncbi.nlm.nih.gov

Identification and physiological evaluation of the components from citrus fruits as potential drugs for anti-corpulence and anticancer. [2012]

10. Greece pubmed.ncbi.nlm.nih.gov

Effects of prenylflavanones from Sophora species on growth and activation of mouse macrophage-like cell line. [2013]

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

Flavonoid profile and radical-scavenging activity of Mediterranean sweet lemon (Citrus limetta Risso) juice. [2022]

12. 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]

13. Brazil pubmed.ncbi.nlm.nih.gov

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