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

Completed · Not applicable · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01619020

Run by

Fred Hutchinson Cancer Center

People needed

66

Starts

2012-10-01

Expected to finish

2017-08-01

Last updated by the study team

2017-09-13

Who can join

Age: 20 and older, up to 45. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• FHCRC — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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