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FlaxFx, A Research Study of the Effects of Flaxseed Lignans on Colon Health

NCT01619020 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2017-09-13

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Texas A&M University

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Johanna Lampe, PhD Rd · Fred Hutchinson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01619020 on ClinicalTrials.gov