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| Name | Class |
|---|---|
| Canadian Breast Cancer Foundation, Ontario Region (funder) | UNKNOWN |
| University of Toronto | OTHER |
| York University, Institute for Social Research | UNKNOWN |
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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).
PRIMARY OBJECTIVES:
I. 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flaxseed (ground) | Experimental |
| |
| Usual diet | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ground flaxseed | Dietary Supplement | 2 tablespoons of ground flaxseed taken daily for approximately 50 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in circulating levels of sex steroid hormones at Day 0 (baseline) compared with ~Day 50 (end of study period) | Day 0 and ~Day 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum enterolignan levels at Day 0 (baseline) compared with ~Day 50 (end of study period) | Day 0 and ~Day 50 |
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Inclusion Criteria:
1. Women residing in Toronto aged 57-64 years old, and post-menopausal.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Cotterchio, PhD | Cancer Care Ontario and Dalla Lana School of Public Health, University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Care Ontario | Toronto | Ontario | M5G2L7 | Canada |
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| Mount Sinai Services |
| UNKNOWN |
| Roswell Park Cancer Institute | OTHER |
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