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 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT00535535
Eligibility Criteria:
Inclusion Criteria:
* Males and females, 18-75 years of age
* Body mass index (BMI) 25-35 and within 10% of maximum weight
* Willing and able to stop fish oil, psyllium, other non-prescribed vitamins/supplements for 1 week prior to study until completion of study
* Willing to not drink alcohol for 24 h before each day of blood sampling
Exclusion Criteria:
* Diabetes or other endocrine disorder, hepatitis or other liver disorder, HIV, or autoimmune disease
* Medication(s) known to affect lipids, including hormonal contraceptives
* Recent acute illness
* Gastrointestinal disease resulting in significant GI dysfunction or malabsorption
* History of fasting TG \>800 mg/dl
* History of ethanol abuse (current intake \>2 drinks/d) or illicit drugs
* History of severe psychiatric illness
* If female, pregnant or breastfeeding
* Participation in an investigational drug study within one month of screening
* Unusual diet or extreme level of physical activity
* Have any other condition, which in the opinion of the investigator, should prohibit the participation in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00535535
Study Brief:
Protocol Section:
NCT00535535