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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01246 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 216812 | Other Identifier | Roswell Park Cancer Institute | |
| U01CA161809 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fred Hutchinson Cancer Center | OTHER |
| National Cancer Institute (NCI) | NIH |
| State University of New York at Buffalo | OTHER |
| University of Toronto |
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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.
PRIMARY OBJECTIVES:
I. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Observation | Other | Participants maintain usual diet and undergo clinical observation |
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| Measure | Description | Time Frame |
|---|---|---|
| Relative percent of Eubacteria composition from quantitative polymerase chain reaction (qPCR) associated with lignan levels | Up to week 21 | |
| Steroid hormone and lignans levels after exposure to a lignan-rich food (flaxseed) | Up to week 21 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Spencer Rosario, PhD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35261959 | Derived | 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. |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| D008043 | Linseed Oil |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| OTHER |
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| Flaxseed | Dietary Supplement | Given PO |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| D005224 | Fats, Unsaturated |
| D005223 | Fats |
| D008055 | Lipids |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |