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

NCT02816125 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2016-10-26

No results posted yet for this study

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.

Conditions

  • Healthy
  • Premenopausal Period

Interventions

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.

Sponsors & Collaborators

  • Alison Duncan

    collaborator UNKNOWN
  • University of Guelph

    lead OTHER

Principal Investigators

  • Sandy Auld, MSc · Research Ethics Officer, University of Guelph

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2006-12-31
Completion
2006-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02816125 on ClinicalTrials.gov