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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Premenopausal Period
• Intervention / Treatment: Dietary supplement: omega-3 fatty acid

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria: menstruating, pre-menopausal -

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Habitual supplemented; habitual diet with 1.2 g EPA+DHA in capsule form/day.	Dietary supplement: omega-3 fatty acid; 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.
EXPERIMENTAL: Low-fat supplemented; Reduce dietary fat to less than 20% energy, add 1.2 g EPA+DHA in capsule form/day.	Dietary supplement: omega-3 fatty acid; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in estrogen in blood and nipple aspirate fluid	modification of estrogen production following omega-3 fatty acid consumption	3 months
changes in oxidative estrogen metabolites in urine	lower concentrations of oxidized estrogen metabolites expected with omega-3 fatty acid supplementation.	3 months
Body weight changes	lower body weight expected with implementation of the low-fat diet	1 month

Collaborators and Investigators

• Sponsor: University of Guelph
• Collaborators: Alison Duncan
• Investigators: Study Director: Sandy Auld, MSc, Research Ethics Officer, University of Guelph

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Primary Completion (ACTUAL): December 1, 2006
• Study Completion (ACTUAL): December 1, 2006

Study Registration Dates

• First Submitted: June 24, 2016
• First Submitted That Met QC Criteria: June 24, 2016
• First Posted (ESTIMATE): June 28, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: breast cancer; omega-3; fatty acids
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 235

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO