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

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Trial Identification

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

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

Study ID: NCT02816125

Interventions

omega-3 fatty acid

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

Contact Details

Name: Sandy Auld, MSc

Affiliation: Research Ethics Officer, University of Guelph

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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