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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02816125
Enrollment
56
Registered
2016-06-28
Start date
2004-03-31
Completion date
2006-12-31
Last updated
2016-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Premenopausal Period

Keywords

breast cancer, fatty acids, omega-3

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.

Interventions

DIETARY_SUPPLEMENTomega-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.

Sponsors

Alison Duncan
CollaboratorUNKNOWN
University of Guelph
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

menstruating, pre-menopausal -

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
omega-3 fatty acid incorporation into red blood cells3 monthsreplacement 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 fluid3 monthsreplacement 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

MeasureTime frameDescription
changes in estrogen in blood and nipple aspirate fluid3 monthsmodification of estrogen production following omega-3 fatty acid consumption
changes in oxidative estrogen metabolites in urine3 monthslower concentrations of oxidized estrogen metabolites expected with omega-3 fatty acid supplementation.
Body weight changes1 monthlower body weight expected with implementation of the low-fat diet

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026