NCT01237938终止不适用
Pilot Study of the Effect of a Low Glycemic Index Diet on Breast Density (Diet and Breast Health Study )
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Diet Change
研究概览
简要总结
This study is a Pilot Phase II cancer intervention trial of a low glycemic index diet to reduce mammographic density in women at high risk for breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Are between 40 and 60 years of age
- •Still menstruating with at least 10 menstrual cycles in the previous 12 months
- •Not Taking hormone replacement therapy
- •Stable oral contraceptive use (no changes is use in past 12 months nor changes intended during interventional period)
- •Have not been previously diagnosed with breast cancer, DCIS,lobular carcinoma in situ, atypical lobular hyperplasia or atypical hyperplasia
- •No history of breast augmentation or reduction surgery
- •Have no history of any other malignancy (excluding non-melanoma skin cancer) in the previous 5 years
- •Have no history of diabetes or other metabolic diseases requiring dietary modification
- •Have a study baseline mammographic density of at least 50% as estimated by mammographer
- •BIRADS 1 or 2 mammogram if first ever mammogram, otherwise stable mammogram (no change since previous year)
- •Have not followed a weight reduction or Atkins typs diet in the past 6 months Not pregnant or lactating in the past 12 months, nor intending pregnancy during the study period
- •Successful completion of three baseline telephone-administered 24- hour dietary recalls
排除标准
- 未提供
结局指标
主要结局
Diet Change
时间窗: 2 years
To Assess the feasibility of a randomized trial to achieve diet change and promote longterm adoption of a low glycemic index diet intervention among women at high risk for breast cancer (\> 50% of breast area occupied by radiological density)
次要结局
- Biomarkers(4, 8 & 12 months on Treatment)
研究者
研究点 (2)
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