Isoflavone Treatment for Postmenopausal Osteopenia.
Condition: Osteopenia; Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Red clover extract; Supplementation (placebo)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Aglycone isoflavones 80mg/d
Other intervention name(s): Formononetin; Biochanin A; Genistein; Daidzein; Vitamin D; Magnesium; Calcium; Vitamin D; Magnesium; Calcuim
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Genistein; Biochanin A; Daidzein; Formononetin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aglycones; Isoflavones; Red clover; Osteopenia; Menopause; Bone turnover; Bone mineral density