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 @ 5:57 PM
Ignite Modification Date:
2025-12-24 @ 5:57 PM
NCT ID:
NCT01825668
Eligibility Criteria:
Inclusion Criteria:
* Triglycerides (TG) \<3.0 mmol/L
* Body mass index (BMI) between 20 and 30 kg/m2
* Participants must have been breast-fed at least during the first 6 months of their life
Exclusion Criteria:
* History of recent (i.e. less than 1 month) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 3 months
* History of chronic use of alcohol (\>2 drinks/d), smoking, systemic antibodies, corticosteroids, androgens, or phenytoin
* Myocardial infarction, coronary artery bypass, kidney disease, liver disease or other major surgical procedures within the last six months,
* Sitosterolemic patients
* Recent onset of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, or significant current (i.e. 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)
* Exercise greater than walking or running 15 miles/wk or 4,000 kcal/wk
* Participants who have not been breast-fed at all
* Pregnant or planning for pregnancy during the next 5 month period
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01825668
Study Brief:
Protocol Section:
NCT01825668