Effects of Omega-3 Fatty Acids on Risk Factors for Breast Cancer in Pre-menopausal Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- omega-3 fatty acid incorporation into red blood cells
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •menstruating, pre-menopausal -
排除标准
- •pregnant, lactating, post-menopausal, smoking, on birth control pills
结局指标
主要结局
omega-3 fatty acid incorporation into red blood cells
时间窗: 3 months
replacement 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 fluid
时间窗: 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.
次要结局
- changes in estrogen in blood and nipple aspirate fluid(3 months)
- changes in oxidative estrogen metabolites in urine(3 months)
- Body weight changes(1 month)
研究者
Kelly Anne Meckling, PhD
Professor
University of Guelph