Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
85 participants
INTERVENTIONAL
2014-06-30
2016-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Red clover extract
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).
Red clover extract
Aglycone isoflavones 80mg/d
Placebo group
Group recieving daily placebo extract (with no isoflavone content), calcium (1040 mg/d), vitamin D (25µg/d) and magnesium (487mg/d).
Supplementation (placebo)
Interventions
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Red clover extract
Aglycone isoflavones 80mg/d
Supplementation (placebo)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have osteopenia (T score between -1 and -2.5)
* Body Mass Index (BMI) between 20 and 40
Exclusion Criteria
* 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
50 Years
85 Years
FEMALE
No
Sponsors
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European Regional Development Fund
OTHER
The Ministry of Science, Technology and Innovation, Denmark
OTHER_GOV
University of Aarhus
OTHER
Responsible Party
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Per Bendix Jeppesen
Associate Prof., PhD
Principal Investigators
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Per B Jeppesen, Prof PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Medicine and Endocrinology MEA, Aarhus University
Locations
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Aarhus University Hospital
Aarhus, Central Jutland, Denmark
Countries
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References
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Lambert MNT, Thybo CB, Lykkeboe S, Rasmussen LM, Frette X, Christensen LP, Jeppesen PB. Combined bioavailable isoflavones and probiotics improve bone status and estrogen metabolism in postmenopausal osteopenic women: a randomized controlled trial. Am J Clin Nutr. 2017 Sep;106(3):909-920. doi: 10.3945/ajcn.117.153353. Epub 2017 Aug 2.
Other Identifiers
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DASTI
Identifier Type: OTHER
Identifier Source: secondary_id
KLKN 14-04-2014
Identifier Type: -
Identifier Source: org_study_id