FLAX FX, A Research Study of the Effects of Flaxseed Lignans on Colon Health (Flax FX)

This study is currently recruiting participants.
Verified March 2014 by Fred Hutchinson Cancer Research Center
Sponsor:
Collaborators:
Texas A&M University
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01619020
First received: April 16, 2012
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Healthy
Dietary Supplement: Flaxseed Lignans

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Gut Microbiota and Colonic Gene Expression: A Lignan Trial in Humans

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • mRNA expression in colonic mucosal tissue (stroma and epithelial) and exfoliated cells in individuals with low- or high-ENL excretion. [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lignan capsule Dietary Supplement: Flaxseed Lignans
We will use a specially formulated dietary lignan supplement (Lignan Research Inc., San Diego, CA) as a source of lignans for the lignan challenge in the screening study and as a daily supplement in the intervention. It is a flaxseed extract that contains SDG (269 mg/g; 50 mg/capsule), pinoresinol diglucoside (160 mg/g), and lesser amounts of caffeic (50 mg/g), ferulic (40 mg/g) and coumaric acids (30 mg/g). Lignan capsules and placebo capsules will be prepared by Lignan Research, Inc., a well-established supplement company that follows GMP.
Placebo Comparator: Placebo capsule Dietary Supplement: Flaxseed Lignans
We will use a specially formulated dietary lignan supplement (Lignan Research Inc., San Diego, CA) as a source of lignans for the lignan challenge in the screening study and as a daily supplement in the intervention. It is a flaxseed extract that contains SDG (269 mg/g; 50 mg/capsule), pinoresinol diglucoside (160 mg/g), and lesser amounts of caffeic (50 mg/g), ferulic (40 mg/g) and coumaric acids (30 mg/g). Lignan capsules and placebo capsules will be prepared by Lignan Research, Inc., a well-established supplement company that follows GMP.

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
  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619020

Contacts
Contact: Lisa Levy 206 667 4353 llevy@fhcrc.org
Contact: Yvonne Schwarz 206-667-7804 FlaxFX@fhcrc.org

Locations
United States, Washington
FHCRC Recruiting
Seattle, Washington, United States, 98109
Contact: Lisa Levy    206-667-4353    FlaxFX@fhcrc.org   
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Texas A&M University
Investigators
Principal Investigator: Johanna Lampe, PhD Rd Fred Hutchinson Cancer Research Center
  More Information

No publications provided

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01619020     History of Changes
Other Study ID Numbers: FHCRC IR 7532
Study First Received: April 16, 2012
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:
Healthy
Colon

ClinicalTrials.gov processed this record on April 17, 2014