- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05297032
Effects of Quercetin on Metabolic Health
Evaluation of a Computational Model That Predicts the Effects of Quercetin on Metabolic Health Using Biological Age and Other Lipid-related Blood Metrics
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
South Carolina
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Summerville, South Carolina, United States, 29486
- This is a remote study - participants will find a commercial lab location near them.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
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
Exclusion Criteria:
- 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)
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Quercetin Phytosome
All participants will receive Quercetin Phytosome
|
All participants will ingest 1 capsule of Quercetin Phytosome (250 mg) three times daily with meals for 90 days.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Biological Age score from before (day 0) to after (day 90) supplementation
Time Frame: 90 days
|
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
Time Frame: 90 days
|
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
Time Frame: 90 days
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Quantitative changes before and after intervention in Lipoprotein Fractionation, Ion Mobility test (Quest Diagnostics 91604) (Scale: particle number)
|
90 days
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Quality of Life scale changes from before (day 0) to after (day 90) supplementation
Time Frame: 90 days
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Quantitative changes in The Quality of Life Scale (Scale: 1-100 as determined by ref: http://www.jstor.org/stable/4034400)
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lifestyle changes from before (day 0) to after (day 90) supplementation
Time Frame: 90 days
|
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) |
90 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephen Phipps, ND, PhD, Thorne Research Inc.
- Principal Investigator: Loukia Lili, PhD, Thorne Research Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRIn-QP01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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