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

Phase 3

Completed

• Conditions: Healthy; Premenopausal Period
• Interventions: Dietary Supplement: omega-3 fatty acid

• Registration Number: NCT02816125
• Lead Sponsor: University of Guelph

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.

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2016-06-24
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-28
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

menstruating, pre-menopausal -

Exclusion Criteria

pregnant, lactating, post-menopausal, smoking, on birth control pills

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Habitual supplemented	omega-3 fatty acid	habitual diet with 1.2 g EPA+DHA in capsule form/day.
Low-fat supplemented	omega-3 fatty acid	Reduce dietary fat to less than 20% energy, add 1.2 g EPA+DHA in capsule form/day.

Primary Outcome Measures

Name	Time	Method
omega-3 fatty acid incorporation into red blood cells	3 months	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	3 months	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

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