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临床试验/NCT00661856
NCT00661856已完成不适用

The Effect of Increased Soy Protein Intake on Bone Metabolism

Creighton University1 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2001年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
203
试验地点
1
主要终点
Bone Mineral Density

研究概览

简要总结

The aim of the present study was to investigate the effects of soy and soy plus isoflavones on bone mineral Density and physical performance in post menopausal women.

详细描述

Post menopausal estrogen deficiency causes physiologic changes in body composition including decreased lean body weight and bone mass. A decrease in muscle strength along with osteoporosis puts post menopausal women at a high risk of hip fractures causing considerable mortality and morbidity. Estrogen use has been shown to reduce bone density loss and increase muscle strength but given the concerns regarding its use, patients are looking for alternatives such as Soy isoflavones. Most human studies on the effect of Soy on bone mineral density (BMD) in post menopausal women have been short term i.e. 3-6 months and failed to provide conclusive evidence. There is no evidence of its effects on physical performance.

The aim of the present study is to investigate the effects of 25g of soy protein alone or with 90mg of isoflavones on bone mineral Density and physical performance indices in post menopausal women over a duration of 2 years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
55 Years 至 72 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •at least 55-75 years of age
  • •at least 7 years post menopausal either spontaneous or surgical

排除标准

  • •must not have used estrogen for atleast 2 months prior to entering study
  • •must be on no bone active drugs such as bisphosphonates, anti convulsants, calcitonin and long term steroids
  • •osteoporosis (T-score<-2.5)
  • •BMI <18 or >34

研究组 & 干预措施

3

Placebo Comparator

25g of Milk protein

干预措施: Soy protein (Dietary Supplement)

2

Experimental

Soy Isoflavone group 25g of Soy Protein with 90mg of Isoflavones

干预措施: Soy protein (Dietary Supplement)

1

Active Comparator

Soy Protein group 25g of Soy protein with no Isoflavones

干预措施: Soy protein (Dietary Supplement)

结局指标

主要结局

Bone Mineral Density

时间窗: 24 months

次要结局

  • Physical Performance Indices(24 months)

研究者

申办方类型
Other

研究点 (1)

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