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临床试验/NCT02174666
NCT02174666已完成不适用

The Effects of Red Clover Treatment on Bone Tissue Regulation in Postmenopausal Osteopenia.

University of Aarhus1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2014年6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
85
试验地点
1
主要终点
Plasma C-terminal telopeptide (CTX)

研究概览

简要总结

The aim of the project is to execute a double-blind, parallel, randomized 12-month intervention trial on postmenopausal women with osteopenia (low bone mineral density), in order to determine the effects of daily intake of fermented red clover (RC) extract on estrogen dependent bone mineral resorption when compared to placebo. Both groups will recieve equivalent daily calcium, vitamin D and magnesium supplements. The project will also assess whether bioactive compounds in RC can reduce the risk of developing cardiovascular disease.

详细描述

The project aims to determine whether red clover derived isoflavones have capabilities to exert positive effects in conditions of osteoporosis and osteopenia in states estrogen deficiency and/or dysregulation.

The cause of osteopenia in women is thought to arise from the deficiency of and/or dysregulation by estrogen on target tissues. Hormone Replacement Therapy (HRT) has proven to be an effective treatment, however it retains limited use as there is general consensus that it also increases cancer risk. Plant derived compounds that emulate the chemical structure and behaviour of estrogen (known as isoflavones) offer a compelling alternative to HRT, due to their potential to adopt the regulatory roles of estrogen without incurring equivalent negative side effects of HRT.

There are, at present, few or no direct head to head clinical trials assessing combination treatments of isoflavones, vitamin D and calcium in contrast to standard vitamin D and calcium supplementation proscribed to osteopenic patients. Research in this area will therefore provide valuable insight into the effectiveness of isoflavones to reduce resorption and/or to stimulate the formation of bone tissue. Moreover the study will provide a comprehensive assessment of the potential of isoflavones to enhance the efficacy of existing preventative treatments. Outcomes of the project have the prospect to help thousands of middle aged and PM women suffering. Moreover, the project may enable development of functional foods and/or nutraceuticals that can be used as either a preventative measure and/or as a treatment for osteoporosis in states of estrogen deficiency and thereby provide an alternative to Hormone Replacement Therapy that does involve the same side effects and risks.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Age 50-85 years, only women
  • •Have osteopenia (T score between -1 and -2.5)
  • •Body Mass Index (BMI) between 20 and 40

排除标准

  • •Taken specific osteoporosis drugs (i.e. bisphosphonates, PTH, estrogen or strontium ranelate) in the past 3 months
  • •Taken other selective estrogen receptor modulator preparations (raloxifene, tamoxifen or isoflavones) in the past 3 months
  • •Participation in other clinical trials within the last 3 months
  • •Previous history of cardiovascular, psychiatric, neurological, and / or kidney disease
  • •Alcohol or substance abuse or acute illness
  • •Blood pressure> 160/110
  • •Pregnant and breastfeeding women

研究组 & 干预措施

Red clover extract

Active Comparator

Group recieving daily red clover extract containing isoflavones (80 mg/d), along with calcium (1040 mg/d), vitamin D (25µg/d) and magnesium (487mg/d).

干预措施: Red clover extract (Dietary Supplement)

Placebo group

Placebo Comparator

Group recieving daily placebo extract (with no isoflavone content), calcium (1040 mg/d), vitamin D (25µg/d) and magnesium (487mg/d).

干预措施: Supplementation (placebo) (Dietary Supplement)

结局指标

主要结局

Plasma C-terminal telopeptide (CTX)

时间窗: 0 - 12 months

Bone mineral resorption biomarker.

次要结局

  • Bone mineral density via dual energy X-ray absorptiometry(0 - 12 months)

研究者

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

Per Bendix Jeppesen

Associate Prof., PhD

University of Aarhus

研究点 (1)

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