Isoflavone Treatment for Postmenopausal Osteopenia.

Not Applicable

Completed

• Conditions: Osteopenia; Osteoporosis
• Interventions: Dietary Supplement: Supplementation (placebo); Dietary Supplement: Red clover extract

• Registration Number: NCT02174666
• Lead Sponsor: University of Aarhus

Brief 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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-19
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-25
• Primary Completion: 2016-10
• Study Completion: 2016-11
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 85

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Supplementation (placebo)	Group recieving daily placebo extract (with no isoflavone content), calcium (1040 mg/d), vitamin D (25µg/d) and magnesium (487mg/d).
Red clover extract	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).

Primary Outcome Measures

Name	Time	Method
Plasma C-terminal telopeptide (CTX)	0 - 12 months	Bone mineral resorption biomarker.

Secondary Outcome Measures

Name	Time	Method
Bone mineral density via dual energy X-ray absorptiometry	0 - 12 months	Objective measure of bone mineral density and bone mineral content.

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Central Jutland Region, Denmark