OsteopeniaNCT02174666
Isoflavone Treatment for Postmenopausal Osteopenia.
A study testing Red clover extract in people with Osteopenia and Osteoporosis, run by University of Aarhus at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 85 years, women only
- Conditions the study is for
- Osteopenia, Osteoporosis
- What is being tested?
- Red clover extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2014to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50-85 years, only women
- Have osteopenia (T score between -1 and -2.5)
- Body Mass Index (BMI) between 20 and 40
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Red Clover Treatment on Bone Tissue Regulation in Postmenopausal Osteopenia.
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.
Read the 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.
- Conditions
- Osteopenia, Osteoporosis
- Being tested
- Red clover extract, Supplementation (placebo)
- Keywords
- Aglycones, Isoflavones, Red clover, Osteopenia, Menopause, Bone turnover, Bone mineral density
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red clover extractDietary supplement
Also called Formononetin, Biochanin A, Genistein, Daidzein
Aglycone isoflavones 80mg/d
Supplementation (placebo)Dietary supplement
Also called Vitamin D, Magnesium, Calcuim
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Dietary Supplement: Red clover extract |
| 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). Receives: Dietary Supplement: Supplementation (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma C-terminal telopeptide (CTX)
Bone mineral resorption biomarker.
Measured: 0 - 12 months
Secondary outcomes (1)
Bone mineral density via dual energy X-ray absorptiometry
Objective measure of bone mineral density and bone mineral content.
Measured: 0 - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- European Regional Development Fund, The Ministry of Science, Technology and Innovation, Denmark
- Responsible party
- Principal investigator, Per Bendix Jeppesen, University of Aarhus
- Investigators
- Per B Jeppesen, Prof PhD, Principal investigator, Department of Medicine and Endocrinology MEA, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174666
- Sponsor's protocol ID
- KLKN 14-04-2014
- Other IDs
- DASTI
- Status last verified
- Dec 2023
- First submitted
- 19 Jun 2014
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28768651
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Red Clover Treatment on Bone Tissue Regulation in Postmenopausal Osteopenia.
- ClinicalTrials.gov ID
- NCT02174666
- Acronym / sponsor ID
- KLKN 14-04-2014
- Conditions
- Osteopenia, Osteoporosis
- Keywords
- Aglycones, Isoflavones, Red clover, Osteopenia, Menopause, Bone turnover, Bone mineral density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- European Regional Development Fund, The Ministry of Science, Technology and Innovation, Denmark
- Study start
- Jun 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red clover extract | Active comparator | Dietary Supplement: Red clover extractGroup recieving daily red clover extract containing isoflavones (80 mg/d), along with calcium (1040 mg/d), vitamin D (25µg/d) and magnesium (487mg/d). |
| Placebo group | Placebo comparator | Dietary Supplement: Supplementation (placebo)Group recieving daily placebo extract (with no isoflavone content), calcium (1040 mg/d), vitamin D (25µg/d) and magnesium (487mg/d). |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50-85 years, only women
- Have osteopenia (T score between -1 and -2.5)
- Body Mass Index (BMI) between 20 and 40
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red clover extractAlso: Formononetin, Biochanin A, Genistein, DaidzeinAglycone isoflavones 80mg/d | Dietary supplement | Red clover extract |
| Supplementation (placebo)Also: Vitamin D, Magnesium, Calcuim | Dietary supplement | Placebo group |
Primary outcome
Plasma C-terminal telopeptide (CTX)
Time frame: 0 - 12 months
Bone mineral resorption biomarker.
1 secondary outcome
Bone mineral density via dual energy X-ray absorptiometry
Time frame: 0 - 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Derived from this study: PubMed 28768651Lambert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per B Jeppesen, Prof PhD principal investigator
Department of Medicine and Endocrinology MEA, Aarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red clover extract in people with Osteopenia and Osteoporosis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma C-terminal telopeptide (CTX) (time frame: 0 - 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02174666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.