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

NCT ID: NCT01619020

Last Updated: 2017-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2017-08-31

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.

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Flaxseed Lignans

Capsules

Group Type: ACTIVE_COMPARATOR

Flaxseed Lignans

Intervention Type: DIETARY_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.

Placebo

Capsules

Group Type: PLACEBO_COMPARATOR

Flaxseed Lignans

Intervention Type: DIETARY_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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Texas A&M University

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johanna Lampe, PhD Rd

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

FHCRC

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31175806 (View on PubMed)

Other Identifiers

FHCRC IR 7532

Identifier Type: -

Identifier Source: org_study_id