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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT04376632
Eligibility Criteria:
Inclusion Criteria:
* Ages 30-75y with higher cholesterol levels or BMI of 28 kg/m2 or greater (A higher cholesterol level is indicated by "Borderline High/Undesirable" in two or more of the variables (total cholesterol 200-239 mg/dL, LDL cholesterol 130-159 mg/dL, triglycerides 150-199 mg/dL) or "High" in either total cholesterol (240 mg/dL and higher) or LDL (160 mg/dL or higher).
Exclusion Criteria:
* Familial hypercholesterolemia (individuals with LDL levels greater than the 95th percentile or HDL levels lower than the 20th percentile based on age and sex)
* Nut consumption \>2 servings/week or tree nut butter consumption \>3 servings/week
* Hormone replacement therapy \<5 years
* Women who are pregnant or planning to become pregnant
* Regular exercise of \>3 hours/week
* Weight gain or loss of \>5% of body weight during last 3 months
* Plans to begin a weight loss/exercise regiment
* History of medical or surgical events that could affect digestion or swallowing
* Gastrointestinal surgeries, conditions or disorders
* Chronic or metabolic diseases
* Atherosclerosis, previous myocardial infarction, stroke, cancer
* Fasting blood glucose levels \>126 mg/dl
* Blood pressure \>180/120 mmHg
* Medication use that affects digestion, absorption, metabolism
* Lipid-lowering medications
* Medications for diabetes or attention deficit disorders (with or without hyperactivity)
* Steroid/hormone therapies
* Individuals on medically prescribed or special diet
* Individuals with food allergies to foods specifically in the study
* Individuals taking fish oil supplements
* Excessive alcohol consumption (greater than 3 drinks/d for men; greater than 2 drinks/d for women)
* Tobacco or nicotine use
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT04376632
Study Brief:
Protocol Section:
NCT04376632