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Effects of Omega-3 Fatty Acids on Risk Factors for Breast Cancer in Pre-menopausal Women

Primary Purpose

Healthy, Premenopausal Period

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
omega-3 fatty acid
Sponsored by
University of Guelph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy focused on measuring breast cancer, fatty acids, omega-3

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: menstruating, pre-menopausal -

Exclusion Criteria: pregnant, lactating, post-menopausal, smoking, on birth control pills

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Habitual supplemented

    Low-fat supplemented

    Arm Description

    habitual diet with 1.2 g EPA+DHA in capsule form/day.

    Reduce dietary fat to less than 20% energy, add 1.2 g EPA+DHA in capsule form/day.

    Outcomes

    Primary Outcome Measures

    omega-3 fatty acid incorporation into red blood cells
    replacement of omega-6 long chain fatty acids with DHA and EPA in red blood cell membranes
    omega-3 fatty acid incorporation in cell material from nipple aspirate fluid
    replacement of omega-6 fatty acids with omega-3 fatty acids in the cells sloughed into the ductal fluid and collected. Total fatty acids from PL fraction of NAF.

    Secondary Outcome Measures

    changes in estrogen in blood and nipple aspirate fluid
    modification of estrogen production following omega-3 fatty acid consumption
    changes in oxidative estrogen metabolites in urine
    lower concentrations of oxidized estrogen metabolites expected with omega-3 fatty acid supplementation.
    Body weight changes
    lower body weight expected with implementation of the low-fat diet

    Full Information

    First Posted
    June 24, 2016
    Last Updated
    October 24, 2016
    Sponsor
    University of Guelph
    Collaborators
    Alison Duncan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02816125
    Brief Title
    Effects of Omega-3 Fatty Acids on Risk Factors for Breast Cancer in Pre-menopausal Women
    Official Title
    Effects of Omega-3 Fatty Acids on Risk Factors for Breast Cancer in Pre-menopausal Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2004 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    December 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Guelph
    Collaborators
    Alison Duncan

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Healthy premenopausal women were enrolled in a diet intervention study that examined the effect of a combination EPA/DHA supplement on risk factors associated with breast cancer. In a randomized cross-over design, women consumed their habitual diet with a supplement for three menstrual cycles, had three cycles of wash-out and then consumed a low-fat diet with the same supplement. Blood, urine and nipple aspirate fluid were collected periodically over the 10 month protocol and analyzed for biomarkers associated with supplementation and future risk of breast cancer.
    Detailed Description
    Non-pregnant, non-lactating women aged 18+ were recruited by way of posters, to take part in a dietary intervention study that was examining the effects of dietary fat level and fat type on risk factors associated with breast cancer. Women who were normally menstruating, consumed either their habitual diet or a low-fat diet for three menstrual cycles, along with a supplement containing 1.2 g DHA+EPA /day. This was followed by a 3-menstrual cycle washout, where the habitual diet was consumed without a supplement. Subsequently the participants consumed the other diet (either low-fat or habitual) for a further 3 menstrual cycles with the 1.2 g DHA/EPA supplement. Blood, urine and nipple aspirate fluid were collected at the beginning and end of each intervention period and analyzed for a variety of biomarkers. Diet records were collected continuously over the entire study period and periodic 7-day records examined for collection of detailed nutrition information. Anthropometry was completed at each study visit, and nutritional counselling provided throughout.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy, Premenopausal Period
    Keywords
    breast cancer, fatty acids, omega-3

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    56 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Habitual supplemented
    Arm Type
    Active Comparator
    Arm Description
    habitual diet with 1.2 g EPA+DHA in capsule form/day.
    Arm Title
    Low-fat supplemented
    Arm Type
    Experimental
    Arm Description
    Reduce dietary fat to less than 20% energy, add 1.2 g EPA+DHA in capsule form/day.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    omega-3 fatty acid
    Intervention Description
    SEE YOURSELF WELLTM OMEGA-3 Dietary Supplement: See Yourself Well Inc., Leamington, Ontario) containinged 200 mg of EPA and 100 mg of DHA for a total of 1.2 g n-3/day.
    Primary Outcome Measure Information:
    Title
    omega-3 fatty acid incorporation into red blood cells
    Description
    replacement of omega-6 long chain fatty acids with DHA and EPA in red blood cell membranes
    Time Frame
    3 months
    Title
    omega-3 fatty acid incorporation in cell material from nipple aspirate fluid
    Description
    replacement of omega-6 fatty acids with omega-3 fatty acids in the cells sloughed into the ductal fluid and collected. Total fatty acids from PL fraction of NAF.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    changes in estrogen in blood and nipple aspirate fluid
    Description
    modification of estrogen production following omega-3 fatty acid consumption
    Time Frame
    3 months
    Title
    changes in oxidative estrogen metabolites in urine
    Description
    lower concentrations of oxidized estrogen metabolites expected with omega-3 fatty acid supplementation.
    Time Frame
    3 months
    Title
    Body weight changes
    Description
    lower body weight expected with implementation of the low-fat diet
    Time Frame
    1 month

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: menstruating, pre-menopausal - Exclusion Criteria: pregnant, lactating, post-menopausal, smoking, on birth control pills -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sandy Auld, MSc
    Organizational Affiliation
    Research Ethics Officer, University of Guelph
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27687127
    Citation
    Gomes MA, Jia X, Kolenski I, Duncan AM, Meckling KA. The role of background diet on the effects of eicosapentaenoic acid and docosahexaenoic acid supplementation in healthy pre-menopausal women: a randomized, cross-over, controlled study. Lipids Health Dis. 2016 Sep 29;15(1):168. doi: 10.1186/s12944-016-0341-1.
    Results Reference
    derived

    Learn more about this trial

    Effects of Omega-3 Fatty Acids on Risk Factors for Breast Cancer in Pre-menopausal Women

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