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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT02148458
Eligibility Criteria:
Inclusion Criteria:
1. \- The participants in this study will be 50 men and women in the 30 to 65 year age range, who have a BMI in the high-normal to moderately overweight range (i.e. 22 to 28 kg/m2),
2. \- Participants who are eating usual US diets and are sedentary to moderately active (i.e. not exercise trained).
3. \- Participants have at least one of these metabolic abnormalities: pre-hypertension or hypertension (i.e. systolic blood pressure \> 120 mmHg or diastolic blood pressure \> 80 mmHg or specific treatment of previously diagnosed hypertension)10, sub-optimal lipid levels (i.e. LDL-cholesterol \> 100 mg/dl or HDL-cholesterol \< 59 mg/dl or specific treatment for this lipid abnormality)11, impaired fasting glucose or glucose intolerance (i.e. fasting glucose \> 100 mg/dl or 2 hr-glucose during OGTT with a glucose load of 75 g \> 140 mg/dl or specific treatment for previously diagnosed type 2 diabetes)12, or high-risk waist circumference (≥ 94 cm in men and ≥ 80 cm in women)13.
Exclusion Criteria:
\- 1 - History of any chronic disease process that could interfere with interpretation of results 2 - Smoking, pregnancy, alcoholism, psychiatric problems, life situations that would interfere with study participation and compliance.
3 - Currently eating diet similar to Mediterranean diet based on dietary and food frequency questionnaires and 4-day food diary.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT02148458
Study Brief:
Protocol Section:
NCT02148458