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AzTrials

QuercetinNCT05297032

Effects of Quercetin on Metabolic Health

A study testing Quercetin Phytosome in people with Quercetin and Lipid Metabolism, run by Thorne HealthTech, Inc at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Quercetin, Lipid Metabolism, Aging
What is being tested?
Quercetin Phytosome
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
24 Mar 2022to 2 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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
  • Willing and able to avoid use of the following supplements during the study:
  • Quercetin, 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

Who cannot join

  • 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
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  • 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)
  • Type 1 or type 2 diabetes mellitus
  • Habitual drinking (cutoff at PI discretion using the following guidelines: 8 or more drinks a week) or being a current smoker/vaping
  • Pregnant or nursing
  • Women of child-bearing age not using an approved contraceptive
  • Planned major surgery during the study (1 week before first blood draw and during the 90-day supplementation)

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Summerville, South Carolina, 29486

Other trials in United States

About this study

Official title: Evaluation of a Computational Model That Predicts the Effects of Quercetin on Metabolic Health Using Biological Age and Other Lipid-related Blood Metrics

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.

Read the detailed description

Following intake and enrollment steps, including providing consent, and approximately one week before other study activities begin, participants will submit an online questionnaire to collect baseline data about lifestyle factors such as diet, exercise, sleep, stress, and general quality of life. During this period they will also receive the study supplement and schedule their first blood draw at a local-to-them Quest Diagnostics facility. Participants will begin taking the study supplement on the day after their first blood draw. Study dosing consists of one capsule of Quercetin Phytosome (Thorne Research, Inc.; 250 mg) taken three times per day with meals for 90 days. Approximately one week after beginning to take study doses, and bi-weekly thereafter, participants will complete an online questionnaire to monitor lifestyle and quality of life factors. The final questionnaire will be completed on the day of or the day after the last study dose is taken. The day after the last study dose, participants will complete a second blood draw at Quest Diagnostics.

Being tested
Quercetin Phytosome
Keywords
Quercetin, Quercetin Phytosome, Quercefit, Sophora japonica, Lipids, LDL, HDL, LDL Particles, Triglycerides, Cholesterol, Metabolic Age, Biological Age, Metabolic Health, Metabolism, Blood Test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quercetin PhytosomeDietary supplement

    Also called Quercetin, Quercefit, Sophora japonica extract (flower)

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

Study groups in NCT05297032
Study groupRoleWhat they receive
Quercetin PhytosomeExperimentalAll participants will receive Quercetin Phytosome
Receives: Dietary Supplement: Quercetin Phytosome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 90 days

  2. 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)

    Measured: 90 days

  3. 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)

    Measured: 90 days

  4. 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)

    Measured: 90 days

Secondary outcomes (1)

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

    Quantitative changes among any time points in metrics of lifestyle measured by questionnaire.

    Questionnaire metrics and scales:

    Stress: 1-10 (little or none:1, extreme:10) Exercise: 1-10 (little or none:1, extreme:10) Diet: 1-10 (very unhealthy:1, very healthy:10) Sleep: 1-10 (very poor:1, excellent:10)

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2022
  2. Study start24 Mar 2022
  3. Primary completion31 Aug 2022
  4. Study completion2 Sep 2022

Why it stopped: Labs ordering channel is no longer available. Indena (collaborator) opted not to increase funding for an alternative, terminated study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05297032
Sponsor's protocol ID
TRIn-QP01
Status last verified
Jan 2023
First submitted
9 Dec 2021
Last updated
10 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lili L, Smith S, Kunces L, Antonella R, Allegrini P, Togni S, Tongiani S, Rickard N, Readhead B, Phipps S, Zhang B. An Application of a Large-Scale, Data-Driven Approach to Prioritize Compound-Targeted Conditions in the Nutraceutical Space: Case Study of QuercefitTM (Quercetin Phytosome) Toward Unbalanced Lipid Conditions in Metabolically Challenged Adults. Mol Nutr Food Res. 2025 Nov;69(22):e70253. doi: 10.1002/mnfr.70253. Epub 2025 Sep 12.

    PubMed 40936357

Questions about this trial

What is this clinical trial studying?

A study testing Quercetin Phytosome in people with Quercetin and Lipid Metabolism, run by Thorne HealthTech, Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Labs ordering channel is no longer available. Indena (collaborator) opted not to increase funding for an alternative, terminated study.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Biological Age score from before (day 0) to after (day 90) supplementation (time frame: 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05297032, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.

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