No Evidence of DiseaseNCT01698294
Biomarkers in Post-Menopausal Women Receiving Flaxseed
A study testing Clinical Observation, Flaxseed and Laboratory Biomarker Analysis in people with No Evidence of Disease, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This randomized clinical trial studies biomarkers in post-menopausal women receiving flaxseed. Studying samples of blood, urine, and feces in the laboratory from participants receiving flaxseed may help doctors understand the effects of flaxseed on biomarkers. Read more about this study
- Who is it for?
- Ages 45 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- No Evidence of Disease
- What is being tested?
- Clinical Observation, Flaxseed and Laboratory Biomarker Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2012to 8 Jun 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 45 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
- Participant must be a non-Hispanic white or non-Hispanic black (self-reported race) woman 45 to 80 years of age and postmenopausal; postmenopausal will be defined as no menstrual cycle in the past 12 months; women with a hysterectomy but with intact ovaries will be included if aged >= 55 years
- Willingness to comply with the requirements of the study
Who cannot join
- Unwilling or unable to follow protocol requirements
- Self-reported race other than non-Hispanic white or non-Hispanic black
- Use, in the 2 months prior to week 1 visit, of antibiotics, hormone replacement therapy, nonprescription hormones or herbal supplements for menopausal symptoms, or flaxseed supplements
- Nut or seed allergy
- Self-reported inflammatory bowel disease
- Gastric bypass
Show all 10Show fewer
- Use of thyroid replacement medication (Synthroid or similar) for < 1 year
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive flaxseed
- Chemotherapy/radiation within the past year
- Body weight greater than 400 pounds (limit of Tanita scale)
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: A Pilot Study of the Flaxseed Effects on Hormones and Lignans: Role of Race, Genes, and Gut Microbiome
This randomized clinical trial studies biomarkers in post-menopausal women receiving flaxseed. Studying samples of blood, urine, and feces in the laboratory from participants receiving flaxseed may help doctors understand the effects of flaxseed on biomarkers.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine associations between the composition of the gut bacterial communities and baseline levels of the mammalian lignans and steroid hormones.
II. To determine how variation in gut microbial community composition and in steroid hormone and xenobiotic metabolizing genes affects the metabolism of mammalian lignans and steroid hormones after exposure to a lignan-rich food (flaxseed).
III. To determine how these associations differ by race (i.e., African American and European American women).
OUTLINE: Participants are randomized to 1 of 2 treatment groups.
GROUP I: Participants receive flaxseed orally (PO) daily for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group II.
GROUP II: Participants maintain a usual diet for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group I.
After completion of study treatment, participants are followed up for 30 days.
- Conditions
- No Evidence of Disease
- Being tested
- Clinical Observation, Flaxseed, Laboratory Biomarker Analysis, Questionnaire Administration
- Keywords
- gut microbiome, hormones, women, race, phytoestrogens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical ObservationOther
Participants maintain usual diet and undergo clinical observation
FlaxseedDietary supplement
Also called FLAX SEED, Flour, Flaxseed, Linseed
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (flaxseed) | Experimental | Participants receive flaxseed PO daily for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group II. Receives: Dietary Supplement: Flaxseed; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
| Group II (usual diet) | Active comparator | Participants maintain a usual diet for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group I. Receives: Other: Clinical Observation; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative percent of Eubacteria composition from quantitative polymerase chain reaction (qPCR) associated with lignan levels
Measured: Up to week 21
Steroid hormone and lignans levels after exposure to a lignan-rich food (flaxseed)
Measured: Up to week 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study start14 Dec 2012
- Primary completion8 Jun 2017
- Study completion8 Jun 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 No Evidence of DiseaseStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, National Cancer Institute (NCI), State University of New York at Buffalo, University of Toronto
- Responsible party
- Sponsor
- Investigators
- Spencer Rosario, PhD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698294
- Sponsor's protocol ID
- I 216812
- Other IDs
- NCI-2012-01246, I 216812, U01CA161809
- Status last verified
- May 2022
- First submitted
- 4 Sep 2012
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McCann SE, Rodriguez EM, Erwin D, Yao S, Tritchler D, Hullar MAJ, O'Connor T, Lampe JW. Recruitment and Retention of Healthy, Postmenopausal Women of African and European Ancestry: Results from a Dietary Intervention with Repeated Biospecimen Collections. Curr Dev Nutr. 2022 Jan 29;6(3):nzac012. doi: 10.1093/cdn/nzac012. eCollection 2022 Mar.
PubMed 35261959
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Flaxseed Effects on Hormones and Lignans: Role of Race, Genes, and Gut Microbiome
- ClinicalTrials.gov ID
- NCT01698294
- Acronym / sponsor ID
- I 216812
- Conditions
- No Evidence of Disease
- Keywords
- gut microbiome, hormones, women, race, phytoestrogens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, National Cancer Institute (NCI), State University of New York at Buffalo, University of Toronto
- Study start
- 14 Dec 2012 (actual)
- Primary completion
- 8 Jun 2017 (actual)
- Study completion
- 8 Jun 2017 (actual)
- First posted
- 2 Oct 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.
This randomized clinical trial studies biomarkers in post-menopausal women receiving flaxseed. Studying samples of blood, urine, and feces in the laboratory from participants receiving flaxseed may help doctors understand the effects of flaxseed on biomarkers.
Detailed description
PRIMARY OBJECTIVES:
- To determine associations between the composition of the gut bacterial communities and baseline levels of the mammalian lignans and steroid hormones.
II. To determine how variation in gut microbial community composition and in steroid hormone and xenobiotic metabolizing genes affects the metabolism of mammalian lignans and steroid hormones after exposure to a lignan-rich food (flaxseed).
III. To determine how these associations differ by race (i.e., African American and European American women).
OUTLINE: Participants are randomized to 1 of 2 treatment groups.
GROUP I: Participants receive flaxseed orally (PO) daily for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group II.
GROUP II: Participants maintain a usual diet for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group I.
After completion of study treatment, participants are followed up for 30 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (flaxseed) | Experimental | Dietary Supplement: Flaxseed, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationParticipants receive flaxseed PO daily for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group II. |
| Group II (usual diet) | Active comparator | Other: Clinical Observation, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationParticipants maintain a usual diet for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group I. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
- Participant must be a non-Hispanic white or non-Hispanic black (self-reported race) woman 45 to 80 years of age and postmenopausal; postmenopausal will be defined as no menstrual cycle in the past 12 months; women with a hysterectomy but with intact ovaries will be included if aged >= 55 years
- Willingness to comply with the requirements of the study
Key exclusion criteria (10 listed)
- Unwilling or unable to follow protocol requirements
- Self-reported race other than non-Hispanic white or non-Hispanic black
- Use, in the 2 months prior to week 1 visit, of antibiotics, hormone replacement therapy, nonprescription hormones or herbal supplements for menopausal symptoms, or flaxseed supplements
- Nut or seed allergy
- Self-reported inflammatory bowel disease
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 |
|---|---|---|
| Clinical ObservationParticipants maintain usual diet and undergo clinical observation | Other | Group II (usual diet) |
| FlaxseedAlso: FLAX SEED, Flour, Flaxseed, LinseedGiven PO | Dietary supplement | Group I (flaxseed) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Group I (flaxseed), Group II (usual diet) |
| Questionnaire AdministrationAncillary studies | Other | Group I (flaxseed), Group II (usual diet) |
Primary outcome
Relative percent of Eubacteria composition from quantitative polymerase chain reaction (qPCR) associated with lignan levels
Time frame: Up to week 21
Steroid hormone and lignans levels after exposure to a lignan-rich food (flaxseed)
Time frame: Up to week 21
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 9 May 2022.
- Derived from this study: PubMed 35261959McCann SE, Rodriguez EM, Erwin D, Yao S, Tritchler D, Hullar MAJ, O'Connor T, Lampe JW. Recruitment and Retention of Healthy, Postmenopausal Women of African and European Ancestry: Results from a Dietary Intervention with Repeated Biospecimen Collections. Curr Dev Nutr. 2022 Jan 29;6(3):nzac012. doi: 10.1093/cdn/nzac012. eCollection 2022 Mar.
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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.
Spencer Rosario, PhD principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Observation, Flaxseed and Laboratory Biomarker Analysis in people with No Evidence of Disease, run by Roswell Park Cancer Institute 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 3 inclusion and 10 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 9 May 2022. 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. 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?
Relative percent of Eubacteria composition from quantitative polymerase chain reaction (qPCR) associated with lignan levels (time frame: Up to week 21). The study lists 2 primary outcomes in all. 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 NCT01698294, 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 9 May 2022.