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临床试验/NCT02325895
NCT02325895已完成不适用

Effect of Dried Plum on Bone and Bone Biomarkers in Older Women

San Diego State University0 个研究点目标入组 48 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
主要终点
Bone Mineral Density

研究概览

简要总结

The objective of the investigators current study was to examine whether 50 g dried plum would be as effective as 100 g dried plum in reversing bone loss in osteopenic older postmenopausal women.

详细描述

Forty-five randomly assigned into one of three treatment groups: 1) 50g dried plum; 2) 100g dried plum; and 3) control (0g dried plum). All groups received 500mg calcium and 400 IU vitamin D as a daily supplement. Blood samples were collected at baseline, 3 and 6 months to assess biomarkers of bone turnover. Physical activity recall and 3-day food records were obtained at baseline, 3 and 6 months to examine physical activity and dietary confounders as potential covariates

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 79 Years(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • BMD t-score of L1-L4 between -1 to -2.5 standard deviation of the mean
  • Age 65 to 79

排除标准

  • BMD t-score at any site fell below 2.5 standard deviation of the mean
  • Subjects treated with calcitonin, bisphosphonates, raloxifene and/or anabolic agents such as parathyroid hormone and growth hormone, or steroids within three months before the start of the study
  • 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 were not included in the study.

结局指标

主要结局

Bone Mineral Density

时间窗: 6 months

次要结局

  • Changes from baseline in bone specific alkaline phosphatase at 3 months and 6 months(baseline, 3 months and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Shirin Hooshmand

Assistant Professor

San Diego State University

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