Gut Microbiota and Colonic Gene Expression: A Lignan Trial in Humans
20 Years
45 Years
Both
Healthy
Trial Information
Gut Microbiota and Colonic Gene Expression: A Lignan Trial in Humans
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Outcome Measure:
mRNA expression in colonic mucosal tissue (stroma and epithelial) and exfoliated cells in individuals with low- or high-ENL excretion.
Outcome Time Frame:
60 days
Safety Issue:
No
Principal Investigator
Johanna Lampe, PhD Rd
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Institutional Review Board
Study ID:
FHCRC IR 7532
NCT ID:
NCT01619020
Start Date:
October 2012
Completion Date:
August 2016
Related Keywords:
- Healthy
- Healthy
- Colon
Name | Location |
|---|---|
| FHCRC | Seattle, Washington 98109 |
