NCT04785131已完成不适用
The Impact of Consuming California Dried Plums on Bone Health of Young Women Using Hormonal Contraceptives
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Changes in bone mineral density from baseline to 12 months
研究概览
简要总结
The primary objective of this study is to determine if 12 months of consuming 50 grams of dried plum daily will prevent bone loss or augment bone accrual of young adult oral contraceptive (OC) users.
详细描述
Eligible participants will be assigned among three groups 1) control non-OC users, 2) control OC users, and 3) dried plum OC users. OC users will be randomly allocated to the dried plum OC group, which will consume 50 g dried plum daily for 12 months, or a control group, for which dried plums will not be allowed and no control food will be provided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-25
排除标准
- •Metabolic bone disease, renal disease, cancer, CVD, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease or other chronic diseases, heavy smoking (more than twenty cigarettes/day) and current use of any prescription medications known to alter bone and calcium metabolism
- •Regularly consumed dried plum or prune juice
结局指标
主要结局
Changes in bone mineral density from baseline to 12 months
时间窗: At baseline, at 12 months
Bone density measurements with DXA
次要结局
- Changes from baseline in bone specific alkaline phosphatase at 6 months and 12 months(At baseline, at 6 months, at 12 months)
研究者
Shirin Hooshmand
Professor
San Diego State University
研究点 (4)
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