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

University of Guelph

Status and phase: Completed; Phase 3

Conditions: Healthy; Premenopausal Period

Treatments: Dietary Supplement: omega-3 fatty acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02816125

235

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: menstruating, pre-menopausal -

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Habitual supplemented

Active Comparator group

Description:

habitual diet with 1.2 g EPA+DHA in capsule form/day.

Treatment:

Dietary Supplement: omega-3 fatty acid

Low-fat supplemented

Experimental group

Description:

Reduce dietary fat to less than 20% energy, add 1.2 g EPA+DHA in capsule form/day.

Treatment:

Dietary Supplement: omega-3 fatty acid