Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fred Hutchinson Cancer Center
With
Texas A&M University
National Cancer Institute (NCI)
Part 1 (Screening):
Potential participants submit a screening questionnaire for eligibility. Eligible participants will come for an orientation for Part 1. If they consent the study coordinator will measure their height and weight and give them all the materials to do the activities for Part 1.
1. Stool sample
2. Days 1-3: take a lignan pill for three days
3. Day 3: 24-hour urine collection.
No all participants will be eligible for Part 2.
Part 2 (Trial):
Eligible participants will come for an orientation and consent.
Activities:
1. 3-day food record
2. Stool sample
3. Fasting blood draw.
4. Colon cleanse (at home). 2 months- no study activities Period 1,
1\. Day 0: Stool sample 2. Day 0: 24-h urine collection 3. Take study capsule daily for 2 months. 4. Day 54: Stool sample 5. Day 54: 24-hour urine 6. Day 55: Fasting blood draw 7. Day 60 Sigmoidoscopy with biopsies 2 months- no study activities Period 2
1. Day 0: Stool sample
2. Day 0: 24-h urine collection
3. Take the other study capsule daily for 2 months.
4. Day 54: Stool sample
5. Day 54: 24-hour urine
6. Day 55: Fasting blood draw
7. Day 60 Sigmoidoscopy with biopsies
Age
20–45
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
healthy
non-smoking men and women
ages 20-45 y
don't eat a lot of vegetables
You may not be if
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.
