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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT03064932
Eligibility Criteria:
Inclusion Criteria:
* overweight or obese (25-35kg/m2)
* non-smoking
* male or female
* waist circumference \>= 94cm for men and \>=80cm for women
* at least one other of the following: LDL- cholesterol \>130mg/dL; CRP \>1mg/L; triglycerides \>=150mg/dL; HDL \<40mg/dL for men or \<50mg/dL for women; systolic blood pressure \>= 130mmHg or diastolic \>= 85mmHg; fasting glucose \>=100mg/dL
Exclusion Criteria:
* diabetes (fasting glucose \>126mg/dL)
* hypertension (systolic blood pressure \>160mmHg or diastolic blood pressure \>100mmHg)
* prescribed anti-hypertensive or glucose lowering drugs
* established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease
* use of cholesterol/lipid lowering medication or supplementation (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals
* pregnancy or lactation
* weight loss of \>=10% of body weight within the 6 months prior to enrolling in the study
* vegetarianism
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT03064932
Study Brief:
Protocol Section:
NCT03064932