HealthyNCT02501031
Flaxseed Intervention Study to Assess Sex Hormone Levels Among Post-Menopausal Women
A study testing Ground flaxseed in people with Healthy, run by Cancer Care Ontario at 1 site in Canada.
Trial summary
The purpose of this study is to understand whether consuming flaxseed for approximately 50 days may beneficially affect the level of certain hormones in the blood thought to be involved in the development of breast cancer. Read more about this study
- Who is it for?
- Ages 57 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ground flaxseed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to Jan 2018
- 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 57 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Women residing in Toronto aged 57-64 years old, and post-menopausal.
Who cannot join
- Consumers of flaxseed and soy (including supplements) in the past 6 months.
- Consumers of sesame oil and sesame seeds in the past 6 months.
- Women who took antibiotics orally in the past 6 months.
- Women who took hormone replacement therapy or corticosteroids in the past month.
- Non-English speaking.
- Current chronic illnesses such as bowel disease (e.g. IBS - irritable bowel syndrome, or IBD - inflammatory bowel disease, such as Crohn's or ulcerative colitis), diabetes, heart disease (e.g. high cholesterol or high blood pressure and on medication for it), cancer, or another chronic illness.
- Women who are currently taking blood thinners, such as Warfarin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dietary Flaxseed on Circulating Sex Hormone Levels Among Post-menopausal Women - an Intervention Trial to Explore Flaxseed Intake as a Possible Breast Cancer Prevention Strategy
The purpose of this study is to understand whether consuming flaxseed for approximately 50 days may beneficially affect the level of certain hormones in the blood thought to be involved in the development of breast cancer. This study will address the first steps toward the development of possible breast cancer prevention strategies. Differences in hormone levels (from blood samples) will be compared between two groups of women - those in the group assigned to eating ground flaxseed daily and those in the control group (with no change in diet).
Read the detailed description
PRIMARY OBJECTIVES:
- Evaluate whether a dietary flaxseed intervention among post-menopausal women influences circulating levels of sex steroid hormones and estrogen metabolites (including estradiol, estrone, 2-hydroxy(OH)-/16-OH-estrone ratio, SHBG, testosterone, 2-MeOH-E1\&-E2, 4-MeOH-E1\&-E2) thought to be involved in the development of breast cancer.
SECONDARY OBJECTIVES:
II. Assess a) the effect of flaxseed intake on serum enterolignan levels (lignan biomarker), b) the relationship between serum enterolignan and sex hormone levels.
III. Describe adherence to the flaxseed intervention.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM 1: Participants take 2 tablespoons of ground flaxseed daily for approximately 50 days.
ARM 2: Participants maintain their usual diet for approximately 50 days.
All participants will complete a questionnaire and have their blood drawn at the beginning of the study (Day 0) and at the end of the study period (approximately Day 50).
- Conditions
- Healthy
- Being tested
- Ground flaxseed
- Keywords
- Flaxseed, Postmenopause, Hormones, Lignans, No Evidence of Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ground flaxseedDietary supplement
2 tablespoons of ground flaxseed taken daily for approximately 50 days.
| Study group | Role | What they receive |
|---|---|---|
| Flaxseed (ground) | Experimental | Not described Receives: Dietary Supplement: Ground flaxseed |
| Usual diet | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in circulating levels of sex steroid hormones at Day 0 (baseline) compared with ~Day 50 (end of study period)
Measured: Day 0 and ~Day 50
Secondary outcomes (1)
Change in serum enterolignan levels at Day 0 (baseline) compared with ~Day 50 (end of study period)
Measured: Day 0 and ~Day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Care Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation, Ontario Region (funder), University of Toronto, York University, Institute for Social Research, Mount Sinai Services, Roswell Park Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Michelle Cotterchio, PhD, Principal investigator, Cancer Care Ontario and Dalla Lana School of Public Health, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501031
- Sponsor's protocol ID
- CBCF 2014-grant
- Status last verified
- Jan 2018
- First submitted
- 13 Jul 2015
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Flaxseed on Circulating Sex Hormone Levels Among Post-menopausal Women - an Intervention Trial to Explore Flaxseed Intake as a Possible Breast Cancer Prevention Strategy
- ClinicalTrials.gov ID
- NCT02501031
- Acronym / sponsor ID
- CBCF 2014-grant
- Conditions
- Healthy
- Keywords
- Flaxseed, Postmenopause, Hormones, Lignans, No Evidence of Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Cancer Care OntarioUniversity, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation, Ontario Region (funder), University of Toronto, York University, Institute for Social Research, Mount Sinai Services, Roswell Park Cancer Institute
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 17 Jul 2015 (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.
The purpose of this study is to understand whether consuming flaxseed for approximately 50 days may beneficially affect the level of certain hormones in the blood thought to be involved in the development of breast cancer. This study will address the first steps toward the development of possible breast cancer prevention strategies. Differences in hormone levels (from blood samples) will be compared between two groups of women - those in the group assigned to eating ground flaxseed daily and those in the control group (with no change in diet).
Detailed description
PRIMARY OBJECTIVES:
- Evaluate whether a dietary flaxseed intervention among post-menopausal women influences circulating levels of sex steroid hormones and estrogen metabolites (including estradiol, estrone, 2-hydroxy(OH)-/16-OH-estrone ratio, SHBG, testosterone, 2-MeOH-E1\&-E2, 4-MeOH-E1\&-E2) thought to be involved in the development of breast cancer.
SECONDARY OBJECTIVES:
II. Assess a) the effect of flaxseed intake on serum enterolignan levels (lignan biomarker), b) the relationship between serum enterolignan and sex hormone levels.
III. Describe adherence to the flaxseed intervention.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM 1: Participants take 2 tablespoons of ground flaxseed daily for approximately 50 days.
ARM 2: Participants maintain their usual diet for approximately 50 days.
All participants will complete a questionnaire and have their blood drawn at the beginning of the study (Day 0) and at the end of the study period (approximately Day 50).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flaxseed (ground) | Experimental | Dietary Supplement: Ground flaxseed |
| Usual diet | No intervention | – |
Who may qualify
- Ages
- 57 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Women residing in Toronto aged 57-64 years old, and post-menopausal.
Key exclusion criteria (7 listed)
- Consumers of flaxseed and soy (including supplements) in the past 6 months.
- Consumers of sesame oil and sesame seeds in the past 6 months.
- Women who took antibiotics orally in the past 6 months.
- Women who took hormone replacement therapy or corticosteroids in the past month.
- Non-English speaking.
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 |
|---|---|---|
| Ground flaxseed2 tablespoons of ground flaxseed taken daily for approximately 50 days. | Dietary supplement | Flaxseed (ground) |
Primary outcome
Change in circulating levels of sex steroid hormones at Day 0 (baseline) compared with ~Day 50 (end of study period)
Time frame: Day 0 and ~Day 50
1 secondary outcome
Change in serum enterolignan levels at Day 0 (baseline) compared with ~Day 50 (end of study period)
Time frame: Day 0 and ~Day 50
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 12 Jan 2018.
- 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.
Michelle Cotterchio, PhD principal investigator
Cancer Care Ontario and Dalla Lana School of Public Health, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ground flaxseed in people with Healthy, run by Cancer Care Ontario at 1 site in Canada.
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 1 inclusion and 7 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 12 Jan 2018. 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 Canada. 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. 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?
Change in circulating levels of sex steroid hormones at Day 0 (baseline) compared with ~Day 50 (end of study period) (time frame: Day 0 and ~Day 50). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2018.