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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT02210767
Eligibility Criteria:
Inclusion Criteria:
* Aged 30-65 years
* BMI greater than 25 and less than or equal to 40 kg/m2
* Non-smokers
* TG \< 350 mg/dL
* LDL-C between the 25-95th percentile from NHANES:
* Males: 105-194 mg/dL
* Females: 98-190 mg/dL
* Stage I hypertension:
* SBP \> 120 mmHg and/or DBP \> 80 mmHg
* SBP \< 160 mmHg and DBP \< 100 mmHg
* Free of established CVD, stroke, diabetes, liver, kidney or autoimmune disease.
Exclusion Criteria:
* Elevated BP (SBP ≥160 mmHg OR DBP ≥ 100 mmHg)
* A history of myocardial infarction, stroke, diabetes mellitus, liver disease, inflammatory disease, kidney disease, and/or thyroid disease (unless controlled on medication).
* Blood pressure or cholesterol-lowering medication use
* Refusal to discontinue intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, and phytoestrogens).
* Vegetarianism or other dietary practices that are inconsistent with the test diets
* Nut allergies (Other food allergies will be reviewed on a case-by-case basis)
* Refusal to discontinue nutritional supplements, herbs, vitamins or NSAID's
* Latex allergy
* Pregnant or lactating females
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT02210767
Study Brief:
Protocol Section:
NCT02210767