Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT05297032
Eligibility Criteria:
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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT05297032
Study Brief:
Protocol Section:
NCT05297032