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 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT03488992
Eligibility Criteria:
Inclusion Criteria:
* Body Mass Index of 29.9 to 40 kg/m2 ±1 kg/m2
* Waist measurement for males ≥ 102 cm (40 inches) or for females ≥ 89 cm (35 inches)
* two or more of the following risk factors:
* Elevated blood pressure ( 130/85 mm Hg)
* Fasting elevated triglycerides \> 1.69 mmol/L ( 150 mg/dL)
* Elevated fasting glucose \> 5.56 mmol/L ( 100 mg/dL) and \<7.0 mmol/L (\<126 mg/dL)
* Low HDL cholesterol \<1.29 mmol/L ( 50 mg/dL) for females, and \<1.03 mmol/L ( 40 mg/dL) for males
* Not currently taking a multivitamin/mineral, antioxidant supplement, or other dietary supplements or are willing to wash out for 4 weeks before enrollment
Exclusion Criteria:
* Pregnant and/ or lactating females or females trying to become pregnant
* Use of lipid lowering medications
* Lipid lowering OTC or herbal supplements within 3 weeks of enrollment
* Use of conventional multivitamin/mineral, antioxidant supplements or other dietary supplements within four weeks prior to enrollment
* Insulin-dependent Type I and Type II diabetics
* Diabetic men \> 45 years and diabetic women \> 55 years
* Metformin or other diabetes medications are prohibited in this study
* Type II diabetes controlled by diet and/or exercise
* Elevated blood pressure ( 160/95 mm Hg) at screening
* Individuals with a history of coronary artery disease, previous myocardial infarction, peripheral vascular disease, or atherosclerosis
* Men above 50 years and women above 60 years who have a 10-year risk of cardiovascular event FRS between 10% and 19% (inclusive) at screening and who present with one of the following LDL-C \> 3.5 mmol/L, TC/HDL-C ratio \> 5.0, or hs-CRP \> 2 mg/L
* Individuals with a 10-year risk of cardiovascular event FRS \< 10% at screening and present with LDL-C \> 5.0 mmol/L or TC/HDL-C ratio \> 6.0
* Participants taking blood thinners
* Participants with stomach ulcers, gall stones, or bile duct obstruction
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT03488992
Study Brief:
Protocol Section:
NCT03488992