NCT01619020

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

4.8 years

First QC Date

April 16, 2012

Last Update Submit

September 11, 2017

Conditions

Healthy

Keywords

HealthyColon

Outcome Measures

Primary Outcomes (1)

  • mRNA expression in colonic mucosal tissue (stroma and epithelial) and exfoliated cells in individuals with low- or high-ENL excretion.

    60 days

Study Arms (2)

Flaxseed Lignans

ACTIVE COMPARATOR

Capsules

Dietary Supplement: Flaxseed Lignans

Placebo

PLACEBO COMPARATOR

Capsules

Dietary Supplement: Flaxseed Lignans

Interventions

Flaxseed LignansDIETARY_SUPPLEMENT

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.

Flaxseed LignansPlacebo

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • non-smoking men and women
  • ages 20-45 y
  • don't eat a lot of vegetables

You may not qualify 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FHCRC

Seattle, Washington, 98109, United States

Location

Related Publications (1)

  • Lampe JW, Kim E, Levy L, Davidson LA, Goldsby JS, Miles FL, Navarro SL, Randolph TW, Zhao N, Ivanov I, Kaz AM, Damman C, Hockenbery DM, Hullar MAJ, Chapkin RS. Colonic mucosal and exfoliome transcriptomic profiling and fecal microbiome response to a flaxseed lignan extract intervention in humans. Am J Clin Nutr. 2019 Aug 1;110(2):377-390. doi: 10.1093/ajcn/nqy325.

    PMID: 31175806DERIVED

Study Officials

  • Johanna Lampe, PhD Rd

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2012

First Posted

June 14, 2012

Study Start

October 1, 2012

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

September 13, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)