FlaxFx, A Research Study of the Effects of Flaxseed Lignans on Colon Health
| Status: | Recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Healthy Studies |
| Therapuetic Areas: | Oncology, Other |
| Healthy: | No |
| Age Range: | 20 - 45 |
| Updated: | 8/11/2016 |
| Start Date: | October 2012 |
| End Date: | August 2017 |
| Contact: | Lisa Levy |
| Email: | llevy@fhcrc.org |
| Phone: | 206 667 4353 |
Gut Microbiota and Colonic Gene Expression: A Lignan Trial in Humans
Colorectal (CRC) cancer is the third most common cancer in the United States and its
incidence is rising in younger populations. Diet seems to affect risk for CRC.
Many parts of our diet are processed and modified by the microbes or bacteria in our gut.
There are many different types of bacteria in our gut, each one of us has a "community" of
different types and amounts of each type.
When we eat flaxseeds, certain types of bacteria will process them - producing compounds
that can then affect our body. How much of these compounds are produced by each person
depends on the "community" of bacteria in the gut.
Flaxseed and in certain nuts contain lignans, compounds that may have health benefits. Gut
bacteria can convert the lignans into biologically active compounds that in animal models
prevent the development of colon cancer. The investigators will study how these biologically
active compounds affect colon cell-signaling pathways important to colorectal cancer risk.
Results from our study will bridge the current knowledge from animal studies and
epidemiologic studies and may help to inform approaches for future CRC prevention.
incidence is rising in younger populations. Diet seems to affect risk for CRC.
Many parts of our diet are processed and modified by the microbes or bacteria in our gut.
There are many different types of bacteria in our gut, each one of us has a "community" of
different types and amounts of each type.
When we eat flaxseeds, certain types of bacteria will process them - producing compounds
that can then affect our body. How much of these compounds are produced by each person
depends on the "community" of bacteria in the gut.
Flaxseed and in certain nuts contain lignans, compounds that may have health benefits. Gut
bacteria can convert the lignans into biologically active compounds that in animal models
prevent the development of colon cancer. The investigators will study how these biologically
active compounds affect colon cell-signaling pathways important to colorectal cancer risk.
Results from our study will bridge the current knowledge from animal studies and
epidemiologic studies and may help to inform approaches for future CRC prevention.
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
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.
We found this trial at
1
site
Click here to add this to my saved trials
