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

About this trial
This is an interventional prevention trial for Healthy focused on measuring breast cancer, fatty acids, omega-3
Eligibility Criteria
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
NCT ID
NCT02816125
First Posted
June 24, 2016
Last Updated
October 24, 2016
Sponsor
University of Guelph
Collaborators
Alison Duncan
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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