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 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT01619020
Eligibility Criteria:
Inclusion Criteria:
* healthy
* non-smoking men and women
* ages 20-45 y
* don't eat a lot of vegetables
Exclusion Criteria:
* chronic medical illness, history of gastrointestinal disorders (e.g., ulcerative colitis, Crohn disease, celiac sprue, HNPCC, familial adenomatous polyposis, pancreatic disease, previous gastrointestinal resection, radiation or chemotherapy) and cancer (other than non-melanoma skin cancer);
* pregnancy or lactation;
* weight change greater than 4.5 kg within past year;
* oral or IV antibiotic use within the past 3 months;
* alcohol intake of \>2 drinks/day (2 drinks being equivalent to 720 ml beer, 240 ml wine, or 90 ml spirits);
* dietary fiber intake \>15 g/day;
* abnormal renal, liver or metabolic test results at baseline;
* inability to swallow pills;
* contraindications to sigmoidoscopy;
* regular use of prescription or over-the-counter medications, including oral contraceptives;
* known allergy to nuts, seeds and flaxseed;
* intention to relocate out of study area within next 12 months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT01619020
Study Brief:
Protocol Section:
NCT01619020