Clinical effects of a proprietary combination isoflavone nutritional supplement in menopausal women: A pilot trial

Metagenics Inc, Functional Medicine Research Center, Gig Harbor, WA, USA.
Alternative therapies in health and medicine (Impact Factor: 1.24). 09/2005; 11(5):60-5.
Source: PubMed


As they reach menopause, a majority of women living in Westernized countries experience climacteric symptoms. Hormone replacement therapy (HRT) has been used to remediate these symptoms. Recent studies, however, have suggested that HRT may increase the risk of developing breast cancer and cardiovascular disease (CVD). Therefore, many women are looking for alternative treatment options.
This trial was a pilot study to assess the effect of a nutritional supplement containing isoflavones from kudzu and red clover, along with other targeted nutrients on menopausal symptoms and markers of breast cancer and CVD risk. Twenty-five menopausal women suffering from severe hot flushes and night sweats completed a 12-week intervention using this combination isoflavone nutritional supplement.
We observed a 46% decrease in reported hot flushes, from an average of 9.7 to 5.2 per day. Quality of life, as assessed by the standardized Greene Questionnaire, showed similar improvement. Two markers of CVD risk, the ratio of total cholesterol to high-density lipoprotein (HDL) cholesterol and homocysteine, showed modest improvement. A proposed marker of breast cancer risk, the ratio of 2-hydroxyestrone to 16 alpha-hydroxyestrone, also showed a statistically significant improvement.
The results of this pilot trial suggests that this combination isoflavone nutritional supplement may significantly relieve the most troubling symptoms of menopause, as well as confer some chemopreventive and cardioprotective benefits.

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    • "Nevertheless, further research is required to confirm our suggestions and elucidate these possible interactions. The clinical effects of RCI in the treatment of menopausal symptoms have already been established [59] [60] [61] [62] [63] "
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    ABSTRACT: Red clover is an important source of isoflavones; which has been made commercially available as dietary supplements for the treatment of menopausal symptoms. Bioavailability and metabolism of these red clover isoflavones (RCI) have not been studied in detail. Fructooligosaccharides (FOS) stimulate the growth of intestinal bacteria and play an important role in the formation of certain isoflavone metabolites, such as equol and O-desmethylangolensin. To determine the bioavailability of RCI metabolites and analyze whether FOS supplementation could influence their bioavailability. Seventeen healthy adults were enrolled in the study carried out in two periods. In the first, compound bioavailability was determined after consumption of 80mg of RCI (MF11RCE). In the second, a 6-day supplementation of 2×3000mg/day of FOS was administered before isoflavone consumption. Biochanin A and formononetin were rapidly absorbed and both reached maximum concentrations at an average of 5-7h. Demethylation was a major reaction in the metabolic pathway. Daidzein serum level peaked after about 12.6h. Supplementation with FOS led to a significant decrease in the bioavailability of daidzein, dihydroformononetin, dihydrogenistein and dihydrodaidzein. An increase in equol production was also observed which did not reach statistical significance (p>0.05). This study is the first to provide detailed data on RCI bioavailability in humans and determine no influence of FOS yet a trend toward increased equol production. More research is warranted involving a greater sample size. Copyright © 2015. Published by Elsevier B.V.
    Full-text · Article · Jun 2015 · Fitoterapia
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    ABSTRACT: To perform a systematic review and meta-analysis of all randomized, controlled trials of isoflavone supplementation to determine the efficacy of isoflavone therapy in reducing the number of daily menopausal flushes. A comprehensive search of published studies of isoflavone treatment and menopausal flushing was undertaken. Studies were selected if they were randomized, were placebo controlled, provided the number of baseline flushes, the variance in flushes and the reduction in flushes. Effects for isoflavone treatment compared to control were calculated and a meta-analysis was performed. Regression analysis, weighted for the size of the study was performed to investigate the relationship between the dose of isoflavone, or number of baseline flushes and the reduction in flushes achieved compared to control. Isoflavone supplementation was found to be associated with a significant reduction in flushes (effect size -0.28, 95% confidence intervals -0.39 to -0.18, P < 0.0001). Marked heterogeneity was found between the studies, but the effect remained significant when analyzed using a random effects model (delta = -0.49, 95% confidence intervals -0.81 to -0.17, P = 0.001). The percentage reduction in flushes was significantly related to the number of baseline flushes per day and the dose of isoflavone studied (beta = -0.49 and -0.26, respectively, both P < 0.0001). These results suggest that isoflavone supplementation may produce a slight to modest reduction the number of daily flushes in menopausal women and that the benefit may be more apparent in women experiencing a high number of flushes per day.
    Preview · Article · Oct 2006 · Maturitas
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    ABSTRACT: This study examined the combined plant extracts (FGF271) of Estromon in ovariectomized (OVX) rats to determine whether Estromon's significant clinical improvement effects on menopausal symptoms are predominantly due to the phytoestrogenic action of the combined extracts. The results showed that all three FGF271-treated groups had significantly improved serum osteocalcin levels as compared to the control group (p<0.05). In addition, all FGF271- and Estromon-treated groups had increases in femoral bone mineral density (FBMD) (p<0.05), and the increase in the FGF271 group was dose-dependent. A pairwise comparison of the FGF271- and Estromon-treated groups receiving the same dosage of FGF271 indicated that there was no significant difference between the groups. Therefore, the FBMD increases that occurred in the Estromon groups were solely attributable to the phytoestrogenic effects of FGF271. It was conclude that the phytoestrogenic effects of Estromon, as shown in clinical studies, are predominantly caused by FGF271, the mixed extracts of Cynanchum wilfordii, Phlomis umbrosa, and Angelica gigas.
    Preview · Article · Jan 2008 · Korean Journal of Food Science and Technology
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