This trial is active, not recruiting.

Conditions osteopenia, osteoporosis
Treatments red clover extract, supplementation (placebo)
Sponsor University of Aarhus
Collaborator European Regional Development Fund
Start date June 2014
End date June 2016
Trial size 87 participants
Trial identifier NCT02174666, DASTI, KLKN 14-04-2014


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(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).
red clover extract Formononetin
Aglycone isoflavones 80mg/d
(Placebo Comparator)
Group recieving daily placebo extract (with no isoflavone content), calcium (1040 mg/d), vitamin D (25µg/d) and magnesium (487mg/d).
supplementation (placebo) Vitamin D

Primary Outcomes

Plasma C-terminal telopeptide (CTX)
time frame: 0 - 12 months

Secondary Outcomes

Bone mineral density via dual energy X-ray absorptiometry
time frame: 0 - 12 months

Eligibility Criteria

Female participants from 50 years up to 85 years old.

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

Additional Information

Official title The Effects of Red Clover Treatment on Bone Tissue Regulation in Postmenopausal Osteopenia.
Principal investigator Per B Jeppesen, Prof PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Aarhus.