HealthyFlaxFxNCT01619020
FlaxFx, A Research Study of the Effects of Flaxseed Lignans on Colon Health
A study testing Flaxseed Lignans in people with Healthy, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Flaxseed Lignans
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- non-smoking men and women
- ages 20-45 y
- don't eat a lot of vegetables
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gut Microbiota and Colonic Gene Expression: A Lignan Trial in Humans
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.
Read more
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.
Read the 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.
- Stool sample
- Days 1-3: take a lignan pill for three days
- 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:
- 3-day food record
- Stool sample
- Fasting blood draw.
- Colon cleanse (at home). 2 months- no study activities Period 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
- Day 0: Stool sample
- Day 0: 24-h urine collection
- Take the other study capsule daily for 2 months.
- Day 54: Stool sample
- Day 54: 24-hour urine
- Day 55: Fasting blood draw
- Day 60 Sigmoidoscopy with biopsies
- Conditions
- Healthy
- Being tested
- Flaxseed Lignans
- Keywords
- Healthy, Colon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Flaxseed Lignans | Active comparator | Capsules Receives: Dietary Supplement: Flaxseed Lignans |
| Placebo | Placebo comparator | Capsules Receives: Dietary Supplement: Flaxseed Lignans |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRNA expression in colonic mucosal tissue (stroma and epithelial) and exfoliated cells in individuals with low- or high-ENL excretion.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Texas A&M University, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Johanna Lampe, PhD Rd, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619020
- Sponsor's protocol ID
- FHCRC IR 7532
- Acronym
- FlaxFx
- Status last verified
- Sep 2017
- First submitted
- 16 Apr 2012
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31175806
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota and Colonic Gene Expression: A Lignan Trial in Humans
- ClinicalTrials.gov ID
- NCT01619020
- Acronym / sponsor ID
- FlaxFx / FHCRC IR 7532
- Conditions
- Healthy
- Keywords
- Healthy, Colon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Texas A&M University, National Cancer Institute (NCI)
- Study start
- Oct 2012
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 14 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Stool sample
- Days 1-3: take a lignan pill for three days
- 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:
- 3-day food record
- Stool sample
- Fasting blood draw.
- Colon cleanse (at home). 2 months- no study activities Period 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
- Day 0: Stool sample
- Day 0: 24-h urine collection
- Take the other study capsule daily for 2 months.
- Day 54: Stool sample
- Day 54: 24-hour urine
- Day 55: Fasting blood draw
- Day 60 Sigmoidoscopy with biopsies
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flaxseed Lignans | Active comparator | Dietary Supplement: Flaxseed LignansCapsules |
| Placebo | Placebo comparator | Dietary Supplement: Flaxseed LignansCapsules |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy
- non-smoking men and women
- ages 20-45 y
- don't eat a lot of vegetables
Key exclusion criteria (12 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flaxseed LignansWe 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. | Dietary supplement | Flaxseed Lignans, Placebo |
Primary outcome
mRNA expression in colonic mucosal tissue (stroma and epithelial) and exfoliated cells in individuals with low- or high-ENL excretion.
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Derived from this study: PubMed 31175806Lampe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johanna Lampe, PhD Rd principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flaxseed Lignans in people with Healthy, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRNA expression in colonic mucosal tissue (stroma and epithelial) and exfoliated cells in individuals with low- or high-ENL excretion. (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01619020, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2017.