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Botanicals in Postmenopausal Osteoporosis.
Słupski, W, Jawień, P, Nowak, B
Nutrients. 2021;13(5)
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One of the main age-associated hormonal imbalances women experience during peri- and post-menopause is osteoporosis. Oestrogen plays a protective role in maintaining bone mineral density, so a decrease in this hormone that naturally occurs with menopause leads to an increased risk of osteoporosis. Due to the various side effects associated with pharmaceutical drugs, many women seek complementary or alternative treatments during menopause. The aim of this review is to present the current information on the efficacy and mechanism of plant-derived compounds in modulating menopause-associated bone metabolism. The main plant compounds that have been studied in detail are phytoestrogens, specifically isoflavones. The literature shows these compounds not only prevent bone resorption, but also promote bone formation. This review also highlights the many biologically plausible mechanisms by which these compounds influence bone metabolism. According to these findings, the authors conclude there are many bioactive, plant-based compounds that may be useful alternative therapies for peri- and post-menopausal women experiencing osteoporosis. While there is promising potential therapeutic use for these botanicals, further clinical research is needed.
Abstract
Osteoporosis is a systemic bone disease characterized by reduced bone mass and the deterioration of bone microarchitecture leading to bone fragility and an increased risk of fractures. Conventional anti-osteoporotic pharmaceutics are effective in the treatment and prophylaxis of osteoporosis, however they are associated with various side effects that push many women into seeking botanicals as an alternative therapy. Traditional folk medicine is a rich source of bioactive compounds waiting for discovery and investigation that might be used in those patients, and therefore botanicals have recently received increasing attention. The aim of this review of literature is to present the comprehensive information about plant-derived compounds that might be used to maintain bone health in perimenopausal and postmenopausal females.
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Bioactivity of soy-based fermented foods: A review.
Cao, ZH, Green-Johnson, JM, Buckley, ND, Lin, QY
Biotechnology advances. 2019;37(1):223-238
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Fermented foods are growing in popularity in the West due to their unique flavour and nutritional value. This review investigates the fermentation processes, health-associated bioactive components and underlying mechanisms of the popular fermented soy products Natto, fermented soy milk, Tempeh and soy sauce. Each fermented soy product is summarised based on functional activities. The existing literature points to an overall positive effect on bone health and immune activities. Interestingly, each fermented soy food exhibits different profiles of bioactive components and therefore different mechanisms of action. Based on this review, the authors conclude there is a need for further in-depth human studies with large sample sizes and long-term follow up to better understand these foods benefits and potential toxicity.
Abstract
For centuries, fermented soy foods have been dietary staples in Asia and, now, in response to consumer demand, they are available throughout the world. Fermentation bestows unique flavors, boosts nutritional values and increases or adds new functional properties. In this review, we describe the functional properties and underlying action mechanisms of soy-based fermented foods such as Natto, fermented soy milk, Tempeh and soy sauce. When possible, the contribution of specific bioactive components is highlighted. While numerous studies with in vitro and animal models have hinted at the functionality of fermented soy foods, ascribing health benefits requires well-designed, often complex human studies with analysis of diet, lifestyle, family and medical history combined with long-term follow-ups for each subject. In addition, the contribution of the microbiome to the bioactivities of fermented soy foods, possibly mediated through direct action or bioactive metabolites, needs to be studied. Potential synergy or other interactions among the microorganisms carrying out the fermentation and the host's microbial community may also contribute to food functionality, but the details still require elucidation. Finally, safety evaluation of fermented soy foods has been limited, but is essential in order to provide guidelines for consumption and confirm lack of toxicity.
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Dietary Inflammatory Index, Dietary Non-Enzymatic Antioxidant Capacity, and Colorectal and Breast Cancer Risk (MCC-Spain Study).
Obón-Santacana, M, Romaguera, D, Gracia-Lavedan, E, Molinuevo, A, Molina-Montes, E, Shivappa, N, Hebert, JR, Tardón, A, Castaño-Vinyals, G, Moratalla, F, et al
Nutrients. 2019;11(6)
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This study aims to correlate the risk factors of inflammation and antioxidant capacity in cases of colon and breast cancer, using data from a large Spanish case-controlled study (1852 colon cancer subjects, 1567 breast cancer subjects and a total 4933 controls). The role of diet in colon cancer is widely accepted, however it is more controversial with breast cancer where genetic mutations and other lifestyle factors are cited as primary risk factors. What unites these cancers is the inter-related presence of both inflammation and oxidative stress. The dietary inflammatory index (DII®) and non-enzymatic antioxidant capacity (NEAC) were used to evaluate inflammation and oxidative stress using 30 nutrient parameters and 6 inflammatory blood markers. The results showed that colon cancer subjects typically ate a more pro-inflammatory diet compared to controls, with a higher odds ratio of men to women, and tended to be older, heavier and less physically active. The breast cancer subjects also had higher inflammatory scores versus controls but demographically were younger, premenopausal, frequently with a first-degree family link to breast cancer, and including a higher percentage of smokers. For both cancers, inflammation significantly and statistically increased risk factors. Adding in oxidative stress results showed a statistically higher risk of developing colon cancer whilst in breast cancer subjects the risk was increased but non-statistically valid. They did report that meat-eaters had a relative 9% increased risk of Breast cancer. Overall the study concluded that dietary components of inflammation and oxidative stress increased risk of colon cancer but were not statistically valid for breast cancer.
Abstract
Inflammation and antioxidant capacity have been associated with colorectal and breast cancer. We computed the dietary inflammatory index (DII®), and the total dietary non-enzymatic antioxidant capacity (NEAC) and associated them with colorectal and breast cancer risk in the population-based multi case-control study in Spain (MCC-Spain). We included 1852 colorectal cancer and 1567 breast cancer cases, and 3447 and 1486 population controls, respectively. DII score and NEAC were derived using data from a semi-quantitative validated food frequency questionnaire. Unconditional logistic regression models were used to estimate odds ratios (OR) and 95% confidence intervals (95%CI) for energy-adjusted DII (E-DII), and a score combining E-DII and NEAC. E-DII was associated with colorectal cancer risk (OR = 1.93, highest quartile versus lowest, 95%CI:1.60-2.32; p-trend: <0.001); this increase was observed for both colon and rectal cancer. Less pronounced increased risks were observed for breast cancer (OR = 1.22, highest quartile versus lowest, 95%CI:0.99-1.52, p-trend: >0.10). The combined score of high E-DII scores and low antioxidant values were associated with colorectal cancer risk (OR = 1.48, highest quartile versus lowest, 95%CI: 1.26-1.74; p-trend: <0.001), but not breast cancer. This study provides evidence that a pro-inflammatory diet is associated with increased colorectal cancer risk while findings for breast cancer were less consistent.
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Combined bioavailable isoflavones and probiotics improve bone status and estrogen metabolism in postmenopausal osteopenic women: a randomized controlled trial.
Lambert, MNT, Thybo, CB, Lykkeboe, S, Rasmussen, LM, Frette, X, Christensen, LP, Jeppesen, PB
The American journal of clinical nutrition. 2017;106(3):909-920
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Oestrogens play a vital role in maintaining bone health. The natural decline in oestrogen during menopause negatively impacts bone mineral density and increases the risk of osteoporosis and fractures. Standard interventions offered include calcium and vitamin D supplementation and hormone replacement therapy. As hormone replacement therapy is associated with increased cancer risk, there is a need to find effective treatments that display a suitable safety profile for long-term use. Isoflavones are compounds found in legume plants, many of which are dietary staples in some cultures. Isoflavones are phytoestrogens, substances that can selectively interact with human oestrogen receptors. Initial research on Isoflavones indicated that it reduces bone breakdown whilst showing protective effects for certain cancers. This randomized, double- blind, placebo-controlled trial compared the effectiveness of an lactic acid fermented, probiotic-rich isoflavone product from Red Clover (RCE) or a placebo, when given in addition to Calcium, Magnesium and Vitamin D (CMD) in postmenopausal women with osteopenia. Participants were monitored using blood tests assessing phytoestrogen activity and oestrogen metabolism, DXA scans to observe changes in bone structure and activity and dietary questionnaires. A total of 78 participants completed the study. The results showed that twice a day 60 mg isoflavones from RCE had a significant physiological impact on preventing bone loss associated with oestrogen deficiency, and was more effective in preserving bone density than CDM alone. The authors concluded that RCE was close to effectiveness to conventional bone-preserving treatments like hormone therapy but stood out due to its better safety profile and minimal side effects. Gut bacteria enhance the effectiveness of these isoflavones, which can be metabolised into compounds called equol. While before the study none of the participants could produce equol, in the end, half of the participants in the RCE group were able to produce equol, suggesting that the probiotic presence in the supplement positively influenced the participants' gut bacteria, creating favourable conditions. Additionally, RCE treatment led to favourable changes in urinary oestrogen metabolites associated with less carcinogenic oestrogen metabolism. In conclusion, the probiotic RCE, enhanced the effectiveness of CMD in preventing bone loss, whilst also increasing the ability to produce equol.
Expert Review
Conflicts of interest:
None
Take Home Message:
- Fermented red clover extract, rich in bioavailable isoflavones with selective oestrogen receptor affinity and probiotics, combined with traditional supplementation (calcium, magnesium and vitamin D) improves bone mineral density and bone turnover compared to placebo in post menopausal women with osteopenia.
- Combining probiotics with isoflavones appears to enhance intestinal isoflavone uptake and isoflavone metabolism.
Evidence Category:
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A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
This was a well-constructed randomised, parallel-design, placebo-controlled, double-blind trial over 12 months. The primary aim was to determine the effectiveness of a novel fermented red clover extract (RCE) containing isoflavones and probiotics combined with traditional calcium/magnesium/vitamin D supplementation, in comparison with traditional calcium/magnesium/vitamin D supplementation alone on bone mineral density (BMD) in postmenopausal women with osteopenia.
Methods
- The trial followed the guidelines of the Declaration of Helsinki and received ethics approval.
- Inclusion criteria: female; >=1 year postmenopause; age 60-85; and bone T score of -1 to -2.25.
- Exclusion criteria: medical treatment for osteopenia or hormone replacement therapy within the past 3 months; diet rich in or supplementation with isoflavones; supplementation with Vitamin K; medical history of stipulated conditions.
- 85 participants were eligible and randomised to either the control or treatment group.
- Treatment group received 95 mL of RCE twice daily, containing 60 mg isoflavone aglycones and probiotics, plus 1040mg calcium, 487mg magnesium and 25μg Vitamin D daily (CMD/d). Control group received masked RCE placebo plus CMD/d.
Results
- The change in BMD (p=0.043) and T score (p=0.045) showed a statistically significant greater decrease in the lumbar spine, femoral neck and hip of the control group than the RCE treatment group after 12 months of treatment.
- A statistically significant reduction in one bone resorption marker was found in the RCE group compared to control (p=0.045). All other bone biomarkers failed to reach significance.
- Plasma isoflavone concentration was elevated in the RCE treatment group compared to control (p=0.0094).
- The concentration ratios of urinary oestrogen metabolites 2-OH:16αOH was significantly increased in the RCE group compared to control (p=0.026).
Conclusion
Fermented RCE with CMD/d slowed oestrogen-deficient BMD loss and improved one marker of bone turnover in postmenopausal osteopenic women. Combining RCE with CMD/d was found to be more effective in preserving bone density than CMD/d alone in this target group. Probiotics in the fermented RCE appear to enhance intestinal isoflavone uptake, metabolism, and therapeutic effect.
Clinical practice applications:
- Healthcare practitioners working with women in post-menopause with osteopenia could consider the addition of fermented RCE with CMD/d for improved bone mineral density and bone turnover over 12 months.
- Given the positive impact of RCE intake over 12 months on 2-OH:16αOH oestrogen metabolite ratios, healthcare practitioners could consider fermented RCE when HRT is not an available option in relation to cancer risk.
- Based on these results, Nutritional Therapists working with post-menopausal women with osteopenia can focus on dietary isoflavone intake and pre and probiotic foods to support BMD, alongside supplementary options.
Considerations for future research:
- Given the length of time taken in bone remodelling cycles, a clinical trial of more than 2 years would strengthen the evidence provided by DXA scan.
- All trial participants were normotensive and healthy weight. Future studies could include women with hypertension and obesity to determine effects of RCE on bone and blood pressure/lipid markers in this group.
- Controlled feeding studies to determine the dietary effects of isoflavones and pre and probiotic foods would provide additional information in this area.
- Other fermented RCE products should be trialled to replicate findings.
Abstract
Background: Female age-related estrogen deficiency increases the risk of osteoporosis, which can be effectively treated with the use of hormone replacement therapy. However, hormone replacement therapy is demonstrated to increase cancer risk. Bioavailable isoflavones with selective estrogen receptor affinity show potential to prevent and treat osteoporosis while minimizing or eliminating carcinogenic side effects.Objective: In this study, we sought to determine the beneficial effects of a bioavailable isoflavone and probiotic treatment against postmenopausal osteopenia.Design: We used a novel red clover extract (RCE) rich in isoflavone aglycones and probiotics to concomitantly promote uptake and a favorable intestinal bacterial profile to enhance isoflavone bioavailability. This was a 12-mo, double-blind, parallel design, placebo-controlled, randomized controlled trial of 78 postmenopausal osteopenic women supplemented with calcium (1200 mg/d), magnesium (550 mg/d), and calcitriol (25 μg/d) given either RCE (60 mg isoflavone aglycones/d and probiotics) or a masked placebo [control (CON)].Results: RCE significantly attenuated bone mineral density (BMD) loss at the L2-L4 lumbar spine vertebra (P < 0.05), femoral neck (P < 0.01), and trochanter (P < 0.01) compared with CON (-0.99% and -2.2%; -1.04% and -3.05%; and -0.67% and -2.79, respectively). Plasma concentrations of collagen type 1 cross-linked C-telopeptide was significantly decreased in the RCE group (P < 0.05) compared with CON (-9.40% and -6.76%, respectively). RCE significantly elevated the plasma isoflavone concentration (P < 0.05), the urinary 2-hydroxyestrone (2-OH) to 16α-hydroxyestrone (16α-OH) ratio (P < 0.05), and equol-producer status (P < 0.05) compared with CON. RCE had no significant effect on other bone turnover biomarkers. Self-reported diet and physical activity were consistent and differences were nonsignificant between groups throughout the study. RCE was well tolerated with no adverse events.Conclusions: Twice daily RCE intake over 1 y potently attenuated BMD loss caused by estrogen deficiency, improved bone turnover, promoted a favorable estrogen metabolite profile (2-OH:16α-OH), and stimulated equol production in postmenopausal women with osteopenia. RCE intake combined with supplementation (calcium, magnesium, and calcitriol) was more effective than supplementation alone. This trial was registered at clinicaltrials.gov as NCT02174666.
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Combined Red Clover isoflavones and probiotics potently reduce menopausal vasomotor symptoms.
Lambert, MNT, Thorup, AC, Hansen, ESS, Jeppesen, PB
PloS one. 2017;12(6):e0176590
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Menopausal symptoms, such as hot flushes and night sweats, significantly impact the quality of life for women. These, also called, vasomotor symptoms (VMS) are a consequence of the natural decline and dysregulation of the body’s own oestrogen. While hormone therapy is the standard treatment for VMS, it is associated with an increased risk of cancers. Isoflavones, phytoestrogens that selectively interact with human oestrogen receptors, offer a potential alternative. The selective nature of isoflavones, like those from Red Clover (RC), can provide beneficial effects while minimizing cancer risks. These extracts have shown an even greater efficacy if isoflavones undergo fermentation processes. While recent clinical trials of RC for VMS have shown promising results, some of the challenges around research into VMS have been that they are primarily based on subjective experiences. Hence this study also employed hot flush analysis technology to generate objective data, besides blood samples, blood pressure readings, and subjective questionnaires. This randomised, double-blind, placebo control trial assessed the effect of bioavailable RC-derived isoflavones and probiotics in peri-menopausal women experiencing daily VMS. The participants received twice-daily 34 mg/d isoflavones and probiotics or a placebo for 12 weeks. The data from 59 participants was analysed for the results. This indicated that moderate doses of isoflavones from RC and probiotics, effectively reduce both physiological and reported menopausal symptoms. The authors observed discrepancies between physiological and reported measures, which may have been due to reporting biases and missing data in self-reports. Interestingly, both the placebo and treatment groups showed improved symptoms, highlighting the prevalence of the placebo effect in menopausal women and underscoring the challenges associated with self-report measures in menopausal research. Their isoflavones did not exhibit any effect on lowering blood pressure, which confirmed previous research that dietary isoflavones may only impact hypertensive people but not those with normal blood pressure. Isoflavones also did not impact blood lipids. The study highlights the importance of developing and implementing objective assessment methods for interventions targeting menopausal VMS, acknowledging the influence of the prevalent placebo effect. And further demonstrated that well-formulated probiotic isoflavone compounds can be a helpful tool in reducing VMS, with minimal side effects.
Abstract
BACKGROUND Natural estrogen decline leads to vasomotor symptoms (VMS). Hormone therapy alleviates symptoms but increases cancer risk. Effective treatments against VMS with minimal cancer risks are needed. We investigate the effects of a highly bioavailable aglycone rich Red Clover isoflavone treatment to alleviate existing menopausal VMS, assessed for the first time by 24hour ambulatory skin conductance (SC). METHODS AND RESULTS We conducted a parallel, double blind, randomised control trial of 62 peri-menopausal women aged 40-65, reporting ≥ 5 hot flushes/day and follicle stimulating hormone ≥35 IU/L. Participants received either twice daily treatment with bioavailable RC extract (RCE), providing 34 mg/d isoflavones and probiotics, or masked placebo formulation for 12 weeks. The primary outcome was change in daily hot flush frequency (HFF) from baseline to 12 weeks using 24hr SC. Secondary outcomes were change in SC determined hot flush intensity (HFI), self-reported HFF (rHFF) and hot flush severity (rHFS), blood pressure and plasma lipids. A significant decrease in 24hr HFF (P < 0.01) and HFI (P<0.05) was found when comparing change from baseline to 12 months of the RCE (-4.3 HF/24hr, CI -6.8 to -2.3; -12956 μS s-1, CI -20175 to -5737) with placebo (0.79 HF/24hr, CI -1.56 to 3.15; 515 μS s-1, CI -5465 to 6496). rHFF was also significantly reduced (P <0.05)in the RCE (-2.97 HFs/d, CI -4.77 to -1.17) group compared to placebo (0.036 HFs/d, CI -2.42 to 2.49). Other parameters were non-significant. RCE was well tolerated. CONCLUSION Results suggest that moderate doses of RCE were more effective and superior to placebo in reducing physiological and self-reported VMS. Findings support that objective physiological symptom assessment methods should be used together with self-report measures in future studies on menopausal VMS. TRIAL REGISTRATION ClinicalTrials.gov NCT02028702.
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Could gestational diabetes mellitus be managed through dietary bioactive compounds? Current knowledge and future perspectives.
Santangelo, C, Zicari, A, Mandosi, E, Scazzocchio, B, Mari, E, Morano, S, Masella, R
The British journal of nutrition. 2016;115(7):1129-44
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Gestational diabetes mellitus (GDM) is the most common metabolic disorder during pregnancy. Women with GDM are at a high risk of developing type 2 diabetes (T2D) later in life. Moreover, uncontrolled GDM is linked with a detrimental intra-uterine environment, which leads to foetal complications and an increased risk for the child of developing obesity and metabolic disorders. The aim of the review is to examine the current knowledge and issues about the impact of dietary polyphenols on the mechanisms and/or factors regulating glucose homeostasis, inflammation and adipose tissue function in metabolic alterations linked with GDM. Moreover, this study also reviews the role of Omega-3 fatty acids in pregnancy. The study is a descriptive review based on several studies. Literature data is mainly derived from in vitro and animal models. In vitro and animal studies show that almost all subclasses of flavonoids, stilbene RSV and some olive oil phenolic compounds, interact and modulate several molecular pathways regulating insulin. Obesity worsens GDM with increased risk of developing metabolic disorders in both mother and offspring later in life. The adoption of healthy lifestyle, with adherence to a healthy dietary pattern, has positive effects on the prevention and management of diabetes.
Abstract
Gestational diabetes mellitus (GDM) is a serious problem growing worldwide that needs to be addressed with urgency in consideration of the resulting severe complications for both mother and fetus. Growing evidence indicates that a healthy diet rich in fruit, vegetables, nuts, extra-virgin olive oil and fish has beneficial effects in both the prevention and management of several human diseases and metabolic disorders. In this review, we discuss the latest data concerning the effects of dietary bioactive compounds such as polyphenols and PUFA on the molecular mechanisms regulating glucose homoeostasis. Several studies, mostly based on in vitro and animal models, indicate that dietary polyphenols, mainly flavonoids, positively modulate the insulin signalling pathway by attenuating hyperglycaemia and insulin resistance, reducing inflammatory adipokines, and modifying microRNA (miRNA) profiles. Very few data about the influence of dietary exposure on GDM outcomes are available, although this approach deserves careful consideration. Further investigation, which includes exploring the 'omics' world, is needed to better understand the complex interaction between dietary compounds and GDM.