Effects of Quercetin on Metabolic Health

NCT05297032 | Terminated

• 1 other identifier: TRIn-QP01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Quercetin is a natural flavonoid compound widely found in vegetables, fruits, and nuts. It has a long history of use as a dietary supplement. This study aims to assess results from a computational model suggesting that quercetin may offer novel benefits to metabolic health. Participants will take quercetin (as Quercetin Phytosome, a proprietary formulation with enhanced absorption properties) for 90 days while keeping lifestyle habits consistent throughout to estimate net effects of quercetin as much as possible. Blood samples will be collected at the beginning and end of the study to assess the effects of quercetin supplementation on metabolic health metrics such as LDL cholesterol, blood sugar, liver, kidney and immune function and calculated metabolic age. In addition, questionnaires will be completed to ensure compliance with study requirements and assess potential quercetin benefits in the participants' quality of life. This work will provide a proof-of-concept from a computational model of nutraceutical compounds and proposes a new application of quercetin in support of healthy human metabolism.

Conditions

Quercetin; Lipid Metabolism; Aging

Keywords

Quercetin; Quercetin Phytosome; Quercefit; Sophora japonica; Lipids; LDL; HDL; LDL Particles; Triglycerides; Cholesterol; Metabolic Age; Biological Age; Metabolic Health; Metabolism; Blood Test

Outcome Measures

Primary Outcomes (4)

• Change in Biological Age score from before (day 0) to after (day 90) supplementation

  Quantitative changes before and after intervention in calculated metrics of biological age. These metrics are calculated by applying the Klemera-Doubal algorithm to a proprietary set of clinical measures. (Scale for each metric: 0-120) (ref: https://academic.oup.com/biomedgerontology/article/74/Supplement\_1/S52/5625183?login=true)

  90 days

• Change in Apolipoprotein B from before (day 0) to after (day 90) supplementation

  Quantitative changes before and after intervention in Apolipoprotein B test (Quest Diagnostics 91726) (Scale: mg/dL)

  90 days

• Change in Lipoprotein Fractions from before (day 0) to after (day 90) supplementation

  Quantitative changes before and after intervention in Lipoprotein Fractionation, Ion Mobility test (Quest Diagnostics 91604) (Scale: particle number)

  90 days

• Quality of Life scale changes from before (day 0) to after (day 90) supplementation

  Quantitative changes in The Quality of Life Scale (Scale: 1-100 as determined by ref: http://www.jstor.org/stable/4034400)

  90 days

Secondary Outcomes (1)

• Lifestyle changes from before (day 0) to after (day 90) supplementation

  90 days

Study Arms (1)

Quercetin Phytosome

EXPERIMENTAL

All participants will receive Quercetin Phytosome

Dietary Supplement: Quercetin Phytosome

Interventions

Quercetin Phytosome DIETARY_SUPPLEMENT

All participants will ingest 1 capsule of Quercetin Phytosome (250 mg) three times daily with meals for 90 days.

Also known as: Quercetin, Quercefit, Sophora japonica extract (flower)

Quercetin Phytosome

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 20-70 years
• Self-report that, within the past 6 months, a medical professional has informed them of, or a blood test result has shown high-healthy Low Density Lipoprotein (LDL) levels (preferred range, if known: 130-159 mg/dL)
• AND 2 or more of the following 4 (values are preferred, if known):
• Low-healthy fasting High Density Lipoprotein (HDL \< 50 mg/dL)
• High-healthy fasting Triglycerides (TG 150-199 mg/dL)
• High-healthy fasting Blood Sugar (Glucose 100-126 mg/dL)
• Waist Circumference \> 40 in for men or \> 35 in for women (this may be self-measured)
• Also
• 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
• Willing and able to comply with the study schedule (+/- 2 days)
• Willing and able to complete online questionnaires
• Willing and able to check email for study-related messages regularly (daily) and to use email as the primary means of communication for non-emergency study-related contact with the study team
• Informed consent to participate in the study discussed and signed
• Willing and able to avoid making changes to diet, sleep, stress, exercise, and other lifestyle factors that may influence the study metrics

You may not qualify if:

• Individuals who live in NY, NJ, RI, SD, ND, HI, or MD (due to lack of availability of WellnessFX or Quest services)
• Individuals who are currently taking any lipid-lowering medications (including statins) or have taken them within the past 6 months.
• Individuals who are currently taking or have taken any lipid-lowering supplements (including quercetin) consistently in the past 4 weeks. Excluded supplements are products that contain:
• o Berberine, Red Yeast Rice, Fish Oil, Bergamot Juice Extract, Pantethine, Vitamin D3 dosing over 5,000IU daily, Pterostilbene, Aged Garlic, Phytosterols, Niacin (crystalline/acid, not niacinamide), Meriva/curcumin/turmeric
• Diagnosed with metabolic syndrome
• Being treated for hypertension
• Known allergy or sensitivity to any components of the trial's nutritional supplement
• Myocardial infarction, coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, or stent within five years
• Known clinical coronary heart disease symptoms
• Known clinical angina
• History of cerebrovascular accident
• Creatinine \> 2.5 mg/dL
• Chronic liver disease with AST, ALT, or alkaline phosphatase over 1.5 times normal
• Known cancer within two years
• Clinical congestive heart failure (systolic or diastolic CHF)

Sponsors & Collaborators

• Thorne HealthTech, Inc: lead
• Indena S.p.A: collaborator

Study Sites (1)

This is a remote study - participants will find a commercial lab location near them.

Summerville, South Carolina, 29486, United States

Location

MeSH Terms

Interventions

Quercetin

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Stephen Phipps, ND, PhD

  Thorne HealthTech, Inc

  PRINCIPAL INVESTIGATOR

• Loukia Lili, PhD

  Thorne HealthTech, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: March 25, 2022
• Study Start: March 24, 2022
• Primary Completion: August 31, 2022
• Study Completion: September 2, 2022
• Last Updated: January 10, 2023

Record last verified: 2023-01

Locations

US (1)