Abstract

Objective. To investigate the effect by which daily consumption of a novel red clover (RC) extract influences bone health, inflammatory status, and cardiovascular health in healthy menopausal women. Design. A 12-week randomized, double-blinded, placebo-controlled trial involving 60 menopausal women receiving a daily dose of 150 mL RC extract containing 37.1 mg isoflavones (33.8 mg as aglycones) or placebo. Methods. Bone parameters were changes in bone mineral density (BMD), bone mineral content (BMC), and T-score at the lumbar spine and femoral neck. Bone turnover (CTx) and inflammatory markers were measured in plasma and finally blood pressure (BP) was evaluated. Results. RC extract had positive effect on bone health, and only the women receiving the placebo experienced a decline in BMD (p < 0.01) at the lumbar spine. T-score at the lumbar spine only decreased in the placebo group (p < 0.01). CTx decreased in the RC group with −9.94 (±4.93)%, although not significant. Conclusion. Daily consumption of RC extract over a 12-week period was found to have a beneficial effect on bone health in menopausal women based on BMD and T-score at the lumbar spine and plasma CTx levels. No changes in BP or inflammation markers were found and no side effects were observed.

Highlights

  • Menopause is a natural occurring part of life characterized by amenorrhea due to the cessation of the ovarian function causing reduced circulating estrogens levels

  • Placebo-controlled intervention study, which included 60 healthy menopausal women, we found that a daily supplement of red clover extract containing isoflavones, mainly in the aglycone form, had positive effect on bone health

  • The spinal bone mineral density (BMD), T-score, and CTx levels all improved in the group receiving the active red clover (RC) supplement, but no effects were found on inflammatory markers and blood pressure

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Summary

Introduction

Menopause is a natural occurring part of life characterized by amenorrhea due to the cessation of the ovarian function causing reduced circulating estrogens levels. The maintenance of bone homeostasis in mammals is influenced by estrogens and the decline in endogenous estrogen (especially 17β-estradiol) during and after menopause. It results in enhanced bone resorption accompanied by impaired bone formation, regeneration, and increase of fat tissue in the bone marrow [1, 2]. In 2002 the first publication [5] from the Women’s Health Initiative trial yielded statistically significant increases in cases of breast cancer and cardiovascular events in HRT-treated women. This prompted sudden changes to recommendations concerning HRT. Due to the critical risk-benefit profile, pharmacological treatment cannot be used in cases of low osteoporosis risk, and osteopenia itself is not a criterion for pharmacotherapy under current international guidelines [6]

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