Clinical trial NCT02816125: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Premenopausal Period
Keywords: breast cancer
fatty acids
omega-3
Lead sponsor: University of Guelph
Sponsor class: OTHER
Collaborators: name: Alison Duncan
First posted: 2016-06-28
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria: menstruating, pre-menopausal -

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

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Primary outcomes:
measure: omega-3 fatty acid incorporation into red blood cells
timeFrame: 3 months
measure: omega-3 fatty acid incorporation in cell material from nipple aspirate fluid
timeFrame: 3 months
Secondary outcomes:
measure: changes in estrogen in blood and nipple aspirate fluid
timeFrame: 3 months
measure: changes in oxidative estrogen metabolites in urine
timeFrame: 3 months
measure: Body weight changes
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Research Ethics Officer, University of Guelph
name: Sandy Auld, MSc
role: STUDY_DIRECTOR
References:
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.