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 @ 6:30 PM
Ignite Modification Date:
2025-12-24 @ 6:30 PM
NCT ID:
NCT00640757
Eligibility Criteria:
Inclusion Criteria:
* Male or female between the ages of 21 to 60, inclusive
* Waist greater than 40 inches for men and 35 inches for women
* Weight has been stable for at least 6 months (no more than 5 pounds gained or lost)
* For women of childbearing potential: subject must be willing to use acceptable form of contraception (pill, condom, diaphragm etc.)
* At least 2 of the following:
HDL cholesterol
* Men \< 40 mg/dL
* Women \< 50 mg/dL Triglycerides ≥150 mg/dL Blood pressure ≥130/≥ 85 mmHg Fasting glucose ≥110-125 mg/dL
Exclusion Criteria:
* Type 1 or Type 2 diabetes
* History of heart attack or stroke
* Pregnant or breastfeeding or planning to become pregnant during the study
* Cancer (other than non-melanoma skin) within the last 5 years
* Significant illness requiring medication
* Inability to read and follow directions in English
* Donated blood in the last 2 months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT00640757
Study Brief:
Protocol Section:
NCT00640757