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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy, Premenopausal Period

Intervention / Treatment
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* Dietary Supplement: omega-3 fatty acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: menstruating, pre-menopausal - Exclusion Criteria: pregnant, lactating, post-menopausal, smoking, on birth control pills -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Habitual supplemented<br>habitual diet with 1.2 g EPA+DHA in capsule form/day. | Dietary Supplement: omega-3 fatty acid<br>* 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.<br>|
| Experimental: Low-fat supplemented<br>Reduce dietary fat to less than 20% energy, add 1.2 g EPA+DHA in capsule form/day. | Dietary Supplement: omega-3 fatty acid<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, fatty acids, omega-3