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:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 12:08 AM
NCT ID:
NCT03064958
Eligibility Criteria:
Inclusion Criteria:
* male aged 40-65 years
* BMI 25-35kg/m2
* nonsmoking
* waist circumference =/\> 94cm and at least one other CVD risk factor (elevated LDL-C (\> 130 mg/dL), CRP (\> 1 mg/L), elevated Triglycerides (≥ 150 mg/dL), reduced HDL-cholesterol (\< 40 mg/dL), elevated blood pressure (systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg), elevated fasting glucose (≥ 100 mg/dL))
* low herb/spice consumers (consumption \<1/day)
Exclusion Criteria:
* Chronic disease risk factors that are diagnostic of diabetes (fasting glucose \> 126 mg/dL) or hypertension (SBP \>160 mm Hg or DBP \> 100 mm Hg).
* Prescription of anti-hypertensive or glucose lowering drugs.
* Established CVD, stroke, diabetes, liver, kidney or autoimmune disease
* Use of cholesterol/lipid-lowering medication or supplements (psyllium, fish oil, soy lecithin, and phytoestrogens) and botanicals
* weight loss of ≥10% of body weight within the 6 months prior to enrolling in the study
* vegetarianism
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT03064958
Study Brief:
Protocol Section:
NCT03064958