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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816125
• Other study ID #: 235
• Status: Completed
• Phase: Phase 3
• First received: June 24, 2016
• Last updated: October 24, 2016
• Start date: March 2004
• Est. completion date: December 2006

Study information

• Verified date: October 2016
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: menstruating, pre-menopausal -

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Neoplasms
• Healthy
• Premenopausal Period

Intervention

Dietary Supplement:
• omega-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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Guelph	Alison Duncan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	changes in estrogen in blood and nipple aspirate fluid	modification of estrogen production following omega-3 fatty acid consumption	3 months	No
Secondary	changes in oxidative estrogen metabolites in urine	lower concentrations of oxidized estrogen metabolites expected with omega-3 fatty acid supplementation.	3 months	No
Secondary	Body weight changes	lower body weight expected with implementation of the low-fat diet	1 month	No