Isoflavone Treatment for Postmenopausal Osteopenia.
|ClinicalTrials.gov Identifier: NCT02174666|
Recruitment Status : Unknown
Verified December 2015 by Per Bendix Jeppesen, University of Aarhus.
Recruitment status was: Active, not recruiting
First Posted : June 25, 2014
Last Update Posted : December 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Osteopenia Osteoporosis||Dietary Supplement: Red clover extract Dietary Supplement: Supplementation (placebo)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||87 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effects of Red Clover Treatment on Bone Tissue Regulation in Postmenopausal Osteopenia.|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||September 2016|
Active Comparator: 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).
Dietary Supplement: Red clover extract
Aglycone isoflavones 80mg/d
Placebo Comparator: Placebo group
Group recieving daily placebo extract (with no isoflavone content), calcium (1040 mg/d), vitamin D (25µg/d) and magnesium (487mg/d).
Dietary Supplement: Supplementation (placebo)
- Plasma C-terminal telopeptide (CTX) [ Time Frame: 0 - 12 months ]Bone mineral resorption biomarker.
- Bone mineral density via dual energy X-ray absorptiometry [ Time Frame: 0 - 12 months ]Objective measure of bone mineral density and bone mineral content.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174666
|Aarhus University Hospital|
|Aarhus, Central Jutland Region, Denmark, 8000|
|Principal Investigator:||Per B Jeppesen, Prof PhD||Department of Medicine and Endocrinology MEA, Aarhus University|