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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT03098056
Eligibility Criteria:
Inclusion Criteria:
Generally healthy subjects (men and women ≥ 18 and ≤ 69 years old) were required:
* to be overweight or obese (BMI ≥ 27 kg/m2 and ≤ 50 kg/m2),
* to exhibit visceral obesity (waist circumference ≥ 35 inches for women and ≥ 39 inches for men),
* and demonstrate signs of cardiometabolic dysfunction. Specifically, subjects were required to have:
* elevated LDL cholesterol ≥ 130 mg/dl
* and/or elevated TG defined as TG ≥ 130 mg/dl. Additionally, subjects were required to have at least one of the following criteria (unless subject had both elevated LDL and TG):
* HDL \< 50 mg/dl for women and \< 40 mg/dl for men,
* blood glucose ≥ 100 mg/dl, HbA1C ≥ 5.7%,
* or Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score defined as ≥ 2.0.
Exclusion Criteria included:
* Pregnancy
* Lactation
* Recent changes in prescription medications, over-the-counter medications, medical foods, and nutritional supplements
* Recent or regular use of narcotics, investigational drugs, corticosteroids, anticoagulants, neuroactive medications, or medication or supplements relevant to hyperglycemia or hyperlipidemia
* Chronic use of over-the-counter medication which would interfere with study endpoints including NSAIDS, laxatives and antacids
* Allergy or intolerance to study products
* Serious, unstable medical conditions including known infection with HIV, tuberculosis or hepatitis; cardiovascular disease; Diabetes Mellitus; autoimmune diseases; malignancy; psychiatric disease; substance abuse;
* Abnormal laboratory findings
* Participating in or planning to begin a weight loss diet during the study period
* Difficulty in swallowing pills
* Lifestyle or schedule incompatible with the study protocol.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT03098056
Study Brief:
Protocol Section:
NCT03098056