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Effect of whole soy and purified daidzein on androgenic hormones in chinese equol-producing post-menopausal women: a six-month randomised, double-blinded and Placebo-Controlled trial.
Liu, ZM, Li, G, Zhang, D, Ho, SC, Chen, YM, Ma, J, Huang, Q, Li, S, Ling, WH
International journal of food sciences and nutrition. 2020;(5):644-652
Abstract
A randomised, double-blind and placebo-controlled trial was performed to examine the effects of whole soy and isoflavone daidzein on serum androgenic hormones in Chinese equol-producing post-menopausal women. A total of 270 eligible women aged 45-70 years were randomised to either one of the three iso-caloric supplements: 40 g soy flour (whole soy group), 40 g low-fat milk powder +63 mg daidzein (daidzein group) or 40 g low-fat milk powder (placebo group) daily for 6 months. Fasting venous samples were tested for serum androstenedione (AD), testosterone (T), prolactin, sex hormone binding globulin and dehydroepiandrosterone sulphate. Intention-to-treat analysis indicated that serum T (p = .022) and AD (p = .05) levels modestly but significantly decreased after 6-month daidzein treatment in comparison with placebo, with a mean difference of -0.057 nmol/L (95%CI: -0.185 to 0.070, p = .018) and -0.118 ng/mL (95%CI: -0.240-0.004, p = .045), respectively. This 6-month trial suggested that purified daidzein may exhibit less androgenic effect.Trial registration: The trial was registered in ClinicalTrials.gov with identifier of NCT01270737. (URL: http://clinicaltrials.gov/ct2/show/NCT01270737.).
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Effectiveness of Genistein Supplementation on Metabolic Factors and Antioxidant Status in Postmenopausal Women With Type 2 Diabetes Mellitus.
Braxas, H, Rafraf, M, Karimi Hasanabad, S, Asghari Jafarabadi, M
Canadian journal of diabetes. 2019;(7):490-497
Abstract
OBJECTIVES The risk of type 2 diabetes mellitus (T2DM) increases in women after menopause. Genistein is known to modulate metabolic pathways. The aim of this study was to investigate the effects of genistein supplementation on metabolic parameters, oxidative stress and obesity values in postmenopausal women with T2DM. METHODS This randomized, double-blind, placebo-controlled clinical trial was conducted on 54 postmenopausal women 47 to 69 years of age with T2DM. The genistein group (n=28) was given 2 genistein capsules daily for 12 weeks. Each capsule contained 54 mg genistein. The placebo group (n=26) received 2 placebo capsules daily for the same period. Fasting blood samples, anthropometric measurements, dietary intakes and physical activity levels of subjects were collected at baseline and at the end of the trial. Data were analyzed by independent t test, paired t test and analysis of covariance. RESULTS Genistein supplementation significantly reduced serum levels of fasting blood glucose (FBS), glycated hemoglobin (A1C), serum triglyceride (TG) and malondialdehyde (MDA) and increased total antioxidant capacity (TAC) compared with the placebo group at the end of the study (p<0.05 for all). Serum high-density lipoprotein cholesterol and quantitative insulin sensitivity check index significantly increased within the genistein group. Changes in anthropometric indexes and other variables were not significant in any of the groups. CONCLUSIONS Genistein administration improved FBS, A1C, serum TG, TAC and MDA in postmenopausal women with T2DM and may be useful in the control of metabolic status and oxidative stress in these subjects.
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Novel effects of phytoestrogenic soy isoflavones on serum calcium and chloride in premenopausal women: A 2-year double-blind, randomized, placebo-controlled study.
Lu, LW, Chen, NW, Nayeem, F, Ramanujam, VS, Kuo, YF, Brunder, DG, Nagamani, M, Anderson, KE
Clinical nutrition (Edinburgh, Scotland). 2018;(6 Pt A):1862-1870
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Abstract
BACKGROUND Soy phytoestrogens are potential alternatives to postmenopausal hormone replacement therapy (HRT). Adverse effects of HRT such as myocardial infarction, stroke, and pulmonary embolism are mediated by calcium-induced signaling. OBJECTIVE To determine whether soy isoflavones affect serum calcium in healthy female subjects. DESIGN In a double-blind trial, 197 premenopausal women were randomly assigned to either isoflavone (N = 99) or placebo pills (N = 98) 5 days per week for up to 2 years, plus prenatal vitamins. Isoflavone pills contained 60 mg genistein, 60 mg daidzein and 16.6 mg glycitein (expressed as aglycone equivalents). All pills contained 15 mg riboflavin as an adherence marker. Blood chemistries and urinary daidzein, genistein and riboflavin were measured multiple times during the luteal phase before and during treatment. RESULTS Analysis of the adherent population (N = 83 per group), revealed significantly strong associations between urinary levels of isoflavones and serum concentrations of calcium (regression coefficients 0.082 for daidzein and 0.229 for genistein, all P < 0.01) and chloride (regression coefficient, -1.537 for genistein, P < 0.0001), mediated in part by albumin. The effects amounted to mean changes of +0.24 mg/dL for calcium and -1.45 mEq/L for chloride, with each visit for subjects excreting the most vs. the least amounts of isoflavones. These associations were not evident in the intention-to-treat analysis (N = 197) that did not assess expected variations in isoflavone levels within and between subjects from metabolism and adherence. CONCLUSIONS These novel and strong effects of soy isoflavones on calcium homeostasis have important implications for long term effects of these natural substances on cardiovascular diseases.
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Influence of equol and resveratrol supplementation on health-related quality of life in menopausal women: A randomized, placebo-controlled study.
Davinelli, S, Scapagnini, G, Marzatico, F, Nobile, V, Ferrara, N, Corbi, G
Maturitas. 2017;:77-83
Abstract
OBJECTIVE This study was designed to evaluate the effects of equol and resveratrol supplementation on health-related quality of life (HRQoL) in otherwise healthy menopausal women with hot flashes, anxiety and depressive symptoms. METHODS Sixty recently menopausal women aged 50-55 years were randomized in a 12-week, placebo-controlled trial to receive 200mg of fermented soy containing 10mg of equol and 25mg of resveratrol (1 tablet/day). The primary outcome was the change in score on the Menopause Rating Scale (MRS), used to evaluate the severity of age-/menopause-related complaints. Additional outcome measures included the subject-reported score on the Hamilton Rating Scale for Depression (HAM-D) and Nottingham Health Profile (NHP), which was used specifically to assess sleep quality. RESULTS The symptoms assessed by the MRS improved during treatment in the active group. Comparison between placebo and treatment groups revealed statistically significant improvement in particular for dryness of vagina (-85.7%) (p<0.001), heart discomfort (-78.8%; p<0.001) and sexual problems (-73.3%; p<0.001). On the HAM-D significant improvements at week 12 were seen in work and activities (-94.1%) (p<0.001). Subjects treated with equol and resveratrol also had significant differences in the sleep domain of the NHP (p<0.001). CONCLUSION These findings provide evidence that 12 weeks of dietary supplementation with equol and resveratrol may improve menopause-related quality of life in healthy women.
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Phytoestrogen-Rich Natural Preparation for Treatment of Climacteric Syndrome and Atherosclerosis Prevention in Perimenopausal Women.
Kirichenko, TV, Myasoedova, VA, Orekhova, VA, Ravani, AL, Nikitina, NA, Grechko, AV, Sobenin, IA, Orekhov, AN
Phytotherapy research : PTR. 2017;(8):1209-1214
Abstract
The present study evaluated the risks and benefits of phytoestrogen treatment in healthy perimenopausal women in relation to the dynamics of climacteric syndrome and progression of atherosclerosis. Study participants were treated with placebo or phytoestrogen-rich natural preparation Karinat based on grape (Vitis vinifera) seeds, green tea (Camellia sinensis) leaves, hop (Hunulus lupulus) cone powder and garlic (Allium sativum) powder. The dynamics of climacteric syndrome was evaluated by Kupperman Index and Utian Quality of Life Scale. Atherosclerosis progression was evaluated by measuring carotid intima-media thickness. Significant changes of climacteric syndrome's severity in both Karinat and placebo groups (p = 0.005 and p = 0.001) were obtained after 24 months of follow-up. Detailed analysis of Kupperman Index suggested that Karinat possessed a significant effect on nervousness (p = 0.010), weakness (p = 0.020) and formication (p = 0.010). A significant improvement of medical (p = 0.070) and emotional (p = 0.060) components of Kupperman Index and Utian Quality of Life Scale was also observed in Karinat group. However, difference in carotid intima-media thickness between the two groups was not statistically significant at follow-up. A slight positive effect of phytoestrogens on climacteric syndrome manifestations was demonstrated in this study. Karinat can be used for alleviation of climacteric syndrome and cardiovascular disease prevention in perimenopausal women. Copyright © 2017 John Wiley & Sons, Ltd.
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Long-term exercise training and soy isoflavones to improve quality of life and climacteric symptoms.
Fontvieille, A, Dionne, IJ, Riesco, E
Climacteric : the journal of the International Menopause Society. 2017;(3):233-239
Abstract
OBJECTIVE To verify the efficacy of phytoestrogen supplementation combined with aerobic and resistance training on the improvement of climacteric symptoms and health-related quality of life (HRQoL) in postmenopausal women. METHODS From a pool of women who had participated in a 1-year intervention study and were randomly assigned to either exercise + phytoestrogen (EX + PHY) or exercise + placebo (EX + PL), a total of 31 healthy but overweight women (mean age 59.2 ± 4.8 years, body mass index 29.1 ± 3.5 kg/m2) finished the study (EX + PHY, n = 15; EX + PL, n = 16). All the following variables were measured before, after 6 months and after 12 months of intervention: body composition (fat and lean body mass, DXA), HRQoL (SF-36 questionnaire: physical and mental component summaries and subscales; and the 10-item Perceived Stress Scale questionnaire), climacteric symptoms (Kupperman Index questionnaire). RESULTS After 1 year of intervention, physical functioning (p = 0.003), role-emotional (p = 0.031), vitality (p = 0.007), and global health (p < 0.001) were significantly and similarly increased in both groups. Regarding climacteric symptoms, an improvement in the Kupperman index total score (p = 0.015) was observed. CONCLUSION Our results demonstrate that adding phytoestrogens to exercise training does not provide the additive effect for HRQoL in postmenopausal and overweight women. Moreover, exercise and phytoestrogen may interfere in the improvement of climacteric symptoms in the long term.
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The impact of combined nutraceutical supplementation on quality of life and metabolic changes during the menopausal transition: a pilot randomized trial.
Villa, P, Amar, ID, Bottoni, C, Cipolla, C, Dinoi, G, Moruzzi, MC, Scambia, G, Lanzone, A
Archives of gynecology and obstetrics. 2017;(4):791-801
Abstract
PURPOSE The aim of this study was to assess the efficacy of a combined nutraceutical supplement on symptoms and early metabolic alterations during the menopausal transition. This pilot randomized study was conducted at the service for menopause disorders of the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy. METHODS Ninety women in menopausal transition who attended our service with menopausal symptoms were enrolled in the study. Sixty patients, randomly assigned to the treatment group, were prescribed one daily tablet of a combined nutraceutical compound with phytoestrogen substances, vitamins, micronutrients and passion flower herbal medicine for 6 months. Thirty patients did not receive any treatment and comprised the control group. The intensity of perimenopausal symptoms was assessed by the modified Kuppermann Index (KI) at enrollment and at 3 and 6 months of treatment. At baseline and at the end of the study, patients underwent a clinical evaluation, a pelvic ultrasound and analysis of blood samples. RESULTS In the nutraceutical supplemented group, a significant reduction in menopausal symptoms was demonstrated according to the KI after 3 and 6 months of supplementation (p < 0.01). The within-group analysis of different KI parameters in the treated group showed a significant improvement in hot flushes (p < 0.001), insomnia (p < 0.01), fatigue (p < 0.01) and irritability (p < 0.01). Metabolic parameters did not change significantly in the nutraceutical supplemented group. In the control group, total cholesterol level showed a significant increase (p < 0.05). CONCLUSIONS Combined nutraceutical supplementation provides an effective and safe solution for early symptoms occurring during menopausal transition.
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Comparison of Pueraria mirifica gel and conjugated equine estrogen cream effects on vaginal health in postmenopausal women.
Suwanvesh, N, Manonai, J, Sophonsritsuk, A, Cherdshewasart, W
Menopause (New York, N.Y.). 2017;(2):210-215
Abstract
OBJECTIVES To compare the effects of a 12-week treatment with Pueraria mirifica (PM) gel or a conjugated estrogen cream on vaginal maturation index, vaginal symptom score, vaginal health assessment score, and vaginal flora in postmenopausal women. METHODS In a prospective, noninferiority, randomized controlled study, 82 postmenopausal women with at least one vulvovaginal symptom, that is, dryness, soreness, irritation, dyspareunia, or discharge, were recruited. Participants were randomly assigned into two groups for treatment with either PM gel or conjugated estrogen cream (CEE). The treatment regimen consisted of application of 0.5 g of product intravaginally daily for 2 weeks, and then decreased to three times per week for 10 weeks. Vaginal maturation index, vaginal symptoms score, and vaginal health assessment score were evaluated before the beginning of the study and at 6 weeks and 12 weeks after treatment with PM or CEE. RESULTS The vaginal maturation index increased significantly in both treatment groups at week 12, from 22.44 ± 22.28 to 47.56 ± 29.00 and from 27.07 ± 26.12 to 66.90 ± 22.42 in the PM and the CEE groups, respectively (P < 0.05). A significantly higher effect was, however, observed in the CEE group (P < 0.05). Vaginal symptom scores decreased significantly after treatment in both groups, from 4.37 ± 2.79 to 0.95 ± 1.88 and from 4.15 ± 2.16 to 0.68 ± 1.64 in the PM and the CEE groups, respectively (P < 0.05), with no statistically significant different between the two groups (P > 0.05). CONCLUSIONS The use of a 12-week treatment regimen with Pueraria mirifica gel was shown to be efficacious and safe for the treatment of vulvovaginal atrophy. Conjugated estrogen cream was found to be more effective compared to Pueraria mirifica gel in improving signs of vaginal atrophy and restoring vaginal epithelium at 6 and 12 weeks.
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Collagen concentration on the facial skin of postmenopausal women after topical treatment with estradiol and genistein: a randomized double-blind controlled trial.
Silva, LA, Ferraz Carbonel, AA, de Moraes, ARB, Simões, RS, Sasso, GRDS, Goes, L, Nunes, W, Simões, MJ, Patriarca, MT
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology. 2017;(11):845-848
Abstract
OBJECTIVE The objective of this study is to compare the effects of topical estrogen and genistein (a soy isoflavone) on the facial skin collagen of postmenopausal women not undergoing systemic hormonal therapy. METHODS This is a prospective, double blind, randomized, controlled clinical trial. Volunteer women (N = 30) 45-55 year old from the Endocrine Gynecology sector of the Gynecology Department of the Federal University of São Paulo (UNIFESP). The Ethical Committee of the Federal University of São Paulo approved the study (report no. 386/2004; registration on ClinicalTrials.gov NCT01553773), were assigned to topical treatment with either estrogen or genistein for 24 weeks. We quantified and compared facial collagen concentration before and after each treatment by performing pre-auricular skin biopsies. RESULTS Our data showed an increase in the amount of both type I and type III facial collagen by the end of both treatments. However, the outcomes of the estrogen GI (ER) group were superior to the genistein GII (GEN) group, with statistical significance p < 000.1 Conclusion: Treatment with topical estrogen is superior to genistein, but both have positive impacts on facial skin collagen. Nevertheless, it is still unclear whether prolonged use of genistein and other topical phytoestrogens could produce systemic effects and further research is needed to clarify this question.
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Visfatin correlates with hot flashes in postmenopausal women with metabolic syndrome: effects of genistein.
Bitto, A, Arcoraci, V, Alibrandi, A, D'Anna, R, Corrado, F, Atteritano, M, Minutoli, L, Altavilla, D, Squadrito, F
Endocrine. 2017;(3):899-906
Abstract
During menopause, an increased prevalence of metabolic syndrome (MetS) and central obesity seems to increase hot flashes (HFs). Visfatin is an inflammatory adipokine secreted by visceral fat. We investigated visfatin levels and its relationship with hot flash number and BMI, in postmenopausal women with MetS. We also evaluated the effect of genistein, an isoflavone effective in reducing HFs, on visfatin levels and HFs after 1 year of treatment. This was a randomized, double-blind, placebo-controlled trial. Postmenopausal women with MetS were randomly assigned to receive placebo (n = 60) or 54 mg genistein (n = 60), daily for 1 year. As main outcome measures, hot flashes number and circulating visfatin levels were evaluated. Visfatin significantly correlated with BMI and HFs number in women with MetS at basal. After 6 and 12 months, our results indicate a strong correlation and a significant effect of genistein in reducing both HFs and visfatin in women with MetS. The present study suggests that visfatin plays a role in the vasomotor symptoms, at least in postmenopausal women with metabolic syndrome. Genistein may reduce HFs decreasing the circulating levels of this inflammatory adipokine.