FlaxFx, A Research Study of the Effects of Flaxseed Lignans on Colon Health
Condition: Healthy
Study type: Interventional

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.
    

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
    

Intervention name(s): Flaxseed Lignans
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Healthy; Colon