DIETARY INTERVENTION--WOMEN HIGH RISK FOR BREAST CANCER

描述：（申请人描述）膳食脂肪摄入和消耗 水果和蔬菜的摄入量被认为会影响乳腺癌的风险 在女人身上。 然而，检验这一假设需要定量标记 乳腺癌的风险，将允许及时评估的影响， 方式 为了评估减少和/或增加 建议的临床研究中摄入水果和蔬菜对癌症风险的影响 试验中，申请人计划测量氧化DNA损伤的水平， 胆固醇氧化物。 这些中间生物标志物指示 氧化应激水平，氧化应激与 乳腺癌风险。 有一级亲属患有 乳腺癌患者将从高风险诊所招募。 的女性 进入试验的人将被随机分配到四种饮食之一：1）对照，2） 低脂肪（15%的热量摄入，而不改变水果的摄入量， 蔬菜），3）高水果/蔬菜（8份/天，不改变脂肪 摄入量），以及4）低脂肪饮食，也是水果和蔬菜的高。 我们计划保留30名妇女/饮食组。12个月的干预将包括 个性化的饮食咨询，满足每个人的需求和能力 女人 血液样品、乳腺液（通过表达从 乳头）和四天食物记录的完整饮食分析将被 在研究入组时和12个月期间定期获得 程序. 5-羟甲基-2'-脱氧尿苷，一种氧化的 胸苷残留，将通过气体分析评估血液中的DNA 色谱-质谱法（GC-MS）。 胆固醇氧化物的水平 将通过GC评估血清和乳腺液中的浓度。 细胞的形态 将通过图像分析进行评估，因为形态学 预期变化与氧化应激水平有关。 的 血清和乳房中微量营养素（类胡萝卜素和生育酚）的水平 液体也将被确定并用作水果和蔬菜的监测器 摄入 此外，微量营养素水平可能会影响其他 生物标志物。 这项关于女性饮食的生物学效应的研究， 乳癌高危人士响应“健康人生2000” 癌症预防的目标。 生物标志物的使用将允许 评估饮食调节对癌症的保护作用， 相对较短的一段时间。

Description: (Applicant s Description) Dietary fat intake and consumption of fruits and vegetables have been suggested to influence breast cancer risk in women. Testing this hypothesis, however, requires quantitative markers of breast cancer risk that will allow assessment of the effect in a timely manner. To evaluate the beneficial effect of reducing and/or increasing the intake of fruits and vegetables on cancer risk in the proposed clinical trial, the applicant plans to measure the levels of oxidative DNA damage and cholesterol oxides. These intermediate biomarkers are indicative of oxidative stress levels, and oxidative stress has been associated with breast cancer risk. Eligible women who have first degree relatives with breast cancer will be recruited from a high-risk clinic. The women who enter the trial will be randomized onto one of four diets: 1) control, 2) low-fat (15 percent of caloric intake without altering intake of fruits and vegetables), 3) high fruit/vegetable (8 servings/day without altering fat intake), and 4) a low-fat diet that is also high in fruits and vegetables. We plan to retain 30 women/diet arm. The 12-month intervention will involve individualized dietary counseling that meets the needs and abilities of each woman. Blood samples, breast fluids (obtained by expression from the nipple) and complete dietary analyses of four-day food records will be obtained at study entry and at regular intervals during the 12 month program. The levels of 5-hydroxymethyl-2'-deoxyuridine, an oxidized thymidine residue, will be assessed in DNA from blood by gas chromatography-mass spectrometry (GC-MS). The levels of cholesterol oxide in serum and breast fluids will be assessed by GC. The morphology of cells in the breast fluids will be assessed by image analysis since morphological changes are expected to be related to levels of oxidative stress. The levels of micronutrients (carotenoids and tocopherols) in serum and breast fluids also will be determined and used as a monitor of fruit and vegetable intake. In addition, micronutrient levels may well influence the other biomarkers. This research on the biological effects of diet in women at high risk for breast cancer is responsive to the "Healthy People 2000" objective of cancer prevention. The use of biomarkers will allow to evaluate the cancer-protective effects of dietary modulation over a relatively short period of time.