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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT03020758
Eligibility Criteria:
Inclusion Criteria:
* Body mass index of 25-36 kg/m2
And, at least one of the following:
* LDL-C above 116 mg/dL (3.0 mmol/L)
* Systolic blood pressure 120-159 mmHg
* Diastolic blood pressure 80-99 mmHg
* Increased waist circumference: ≥94 cm for men and ≥80 cm for women
* Elevated glucose (≥ 100 mg/dL and \< 126 mg/dL)
* Triglycerides: above 150 mg/dL (1.69 mmol/L) and below 350 mg/dL (3.95 mmol/L)
* Low HDL-cholesterol: \<40 mg/dL (\< 1.03 mmol/L) for men and \< 50 mg/dL (\<1.29 mmol/L) for women)
Exclusion Criteria:
* Allergies to the test foods
* History of cardiovascular disease, stage II hypertension (BP 160/100 mmHg), kidney disease, diabetes or inflammatory diseases such as gastrointestinal disorders and rheumatoid arthritis
* Use of medication/supplements for elevated lipids, blood pressure, or glucose
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
60 Years
Study:
NCT03020758
Study Brief:
Protocol Section:
NCT03020758