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Completed

NCT Number: NCT02816125

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

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.

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Key information

Conditions

Healthy Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Premenopausal Period Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

menstruating, pre-menopausal -

Exclusion criteria

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

-

Treatment and study plan

Omega-3 fatty acid

Dietary Supplement

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.

Primary outcomes

  1. omega-3 fatty acid incorporation into red blood cells

    Time frame: 3 months

    replacement of omega-6 long chain fatty acids with DHA and EPA in red blood cell membranes

  2. omega-3 fatty acid incorporation in cell material from nipple aspirate fluid

    Time frame: 3 months

    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.

Secondary outcomes

  1. changes in estrogen in blood and nipple aspirate fluid

    Time frame: 3 months

    modification of estrogen production following omega-3 fatty acid consumption

  2. changes in oxidative estrogen metabolites in urine

    Time frame: 3 months

    lower concentrations of oxidized estrogen metabolites expected with omega-3 fatty acid supplementation.

  3. Body weight changes

    Time frame: 1 month

    lower body weight expected with implementation of the low-fat diet

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Collaborators

  • Alison Duncan

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jun 28, 2016
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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