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 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT00923403
Eligibility Criteria:
Inclusion Criteria:
1. Healthy males and females, age 19-60 years old, will be screened for determination of fasting circulating LDL-cholesterol and triglyceride (TG) levels.
2. Subjects accepted into the study will have plasma LDL-C levels between 120 and 200 mg/dl, TG levels below 250 mg/dl, and a body mass index (BMI) between 22 to 32 kg/m2.
3. Subjects must also demonstrate an ability to understand dietary and exercise procedures and be judged as compliant and motivated by the investigators.
4. Subjects will be permitted to take stable doses of thyroid hormone and anti-hypertensive agents, as long as these are continued equivalently throughout the duration of study.
Exclusion Criteria:
1. History of recent (i.e. less than 3 mo) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 6 months.
2. History of chronic use of alcohol (\>2 drinks/d), systemic antibodies, corticosteroids, androgens, or phenytoin.
3. Myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months.
4. Recent onset of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, or significant current (ie. onset within past three months) gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year).
5. Exercise greater than walking or running 15 miles/wk or 4,000 kcal/week.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT00923403
Study Brief:
Protocol Section:
NCT00923403