Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT01619020
Status:
COMPLETED
Last Update Posted:
2017-09-13
First Post:
2012-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FlaxFx, A Research Study of the Effects of Flaxseed Lignans on Colon Health
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Study Overview
Official Title:
Gut Microbiota and Colonic Gene Expression: A Lignan Trial in Humans
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FlaxFx
Brief Summary:
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.
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.
Detailed Description:
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: