Combination therapy of flaxseed and hesperidin enhances the effectiveness of lifestyle modification in cardiovascular risk control in prediabetes: a randomized controlled trial.

BACKGROUND: Regarding the increasing prevalence of cardiometabolic abnormalities, and its association with non-communicable chronic diseases, providing preventive and therapeutic strategies is a priority. A randomized placebo-controlled study was conducted to assess the effects of combination therapy of milled brown flaxseed and hesperidin during lifestyle intervention on controlling cardiovascular risk in prediabetes. METHODS: A total of forty-eight subjects were randomly assigned to receive lifestyle intervention plus combination therapy of brown flaxseed (30 g milled) and hesperidin (two 500 mg capsules) or lifestyle modification alone for 12 weeks. Changes from baseline in anthropometric measures, lipid profile and atherogenic indices, glucose homeostasis parameters, and inflammatory biomarkers was assessed as a primary end point. RESULTS: Anthropometric data comparison between the two groups showed a significant reduction in weight (p = 0.048). Waist circumference reduction was about twice that of the control group (- 6.75 cm vs - 3.57 cm), but this difference was not statistically significant. Comparison of blood pressure changes throughout the study indicated a greater reduction in blood pressure in the intervention group rather than control group (- 5.66 vs. - 1.56 mmHg, P = 0.049). Improvements of lipid profile and atherogenic indices, glucose homeostasis parameters, and inflammatory biomarkers in flaxseed-hesperidin group was significantly more than the control group after 12 weeks of intervention (p < 0.05). CONCLUSION: Our results indicate that co-administration of flaxseed and hesperidin as an adjunct to lifestyle modification program is more effective than lifestyle modification alone in the metabolic abnormalities remission of prediabetic patients. TRIAL REGISTRATION:  The trial was registered with ClinicalTrials.gov, number NCT03737422. Registered 11 November 2018. Retrospectively registered, https://clinicaltrials.gov/ct2/results?cond=&term=NCT03737422&cntry=&state=&city=&dist= .

The effects of soy isoflavones on total testosterone and follicle-stimulating hormone levels in women with polycystic ovary syndrome: a systematic review and meta-analysis.

OBJECTIVES: The aims of this systematic review and meta-analysis were to evaluate the effectiveness of soy isoflavones on serum levels of total testosterone (TT) and follicle-stimulating hormone (FSH) in women with polycystic ovary syndrome (PCOS). METHODS: A meta-analysis was performed by searching for relevant randomised controlled trials (RCTs) in several databases. Of the four trials found, the eligibility criteria to evaluate the efficacy of soy isoflavones on serum levels of FSH were met by three trials and of TT by four trials. The Cochrane scale was used to evaluate the risk of bias. Fixed-effects and random-effects models were used to evaluate overall effect. The χ 2 test (Cochran's Q test) and the I 2 index were used to assess the heterogeneity of RCTs. RESULTS: Our results showed that soy isoflavones significantly decreased TT (weighted mean difference [WMD] - 0.14; 95% confidence interval [CI] - 0.2, -0.02; p = 0.016; I 2 = 89%, p < 0.001) but had no significant effect on FSH levels (WMD -0.25; 95% CI -0.54, 0.02; p = 0.06; I 2 = 0%, p = 0.85). CONCLUSION: Although the results of this meta-analysis showed that soy isoflavones in women with PCOS decreased TT and had no significant effect on FSH, better and more valid studies are needed to confirm these results.

The effects of Melissa officinalis (lemon balm) in chronic stable angina on serum biomarkers of oxidative stress, inflammation and lipid profile.

BACKGROUND AND OBJECTIVES: Coronary artery disease (CAD) is a major cause of death worldwide. Chronic stable angina (CSA) is the primary sign of CAD. Oxidative stress and inflammation play a substantial role in pathogenesis and progression of CAD. The aim of this study was to investigate the effects of oral administration of powdered Melissa officinalis (MO) on biomarkers of oxidative stress, inflammation, and lipid profile in patients with CSA. METHODS AND STUDY DESIGN: A randomized, double-blind, placebo-controlled clinical trial was performed in 80 patients with CSA. The subjects were randomly assigned to obtaineither oral MO 3 g/d (n=40) or placebo (n=40) for eight weeks. Anthropometric indices, biomarkers of oxidative stress, inflammation, and lipid profile were evaluated at baseline and post-intervention. RESULTS: The mean serum concentrations of triglycerides, total-cholesterol, LDL-cholesterol, and malondialdehyde (MDA), and high sensitive C-Reactive Protein (hs-CRP) were lower in the intervention group compared with placebo (p<0.01) post intervention. Moreover, the mean serum concentration of paraxonase 1 (PNO1) and HDL-c were higher (p<0.001) in the intervention group compared with the control group. CONCLUSION: Oral MO supplementation improves the lipid profile, MDA, hs-CRP, and PNO1 in patients with CSA.

The effects of Melissa officinalis supplementation on depression, anxiety, stress, and sleep disorder in patients with chronic stable angina.

BACKGROUND: Despite advances in the treatment of cardiovascular diseases in recent decades, patients experience high levels of depression, anxiety, stress, and insomnia. Since the calming effect of Melissa officinalis (MO) has been known, this study aimed to determine the effects of MO supplementation on depression, anxiety, stress, and sleep disturbances in patients with chronic stable angina (CSA). METHODS: In this double-blind placebo-controlled clinical trial, 80 patients with CSA were divided randomly into two groups (taking 3 g MO supplement or placebo daily for 8 weeks). The shortened 21-item version of the depression, anxiety and stress scale (DASS-21) test and Pittsburgh sleep quality index were done before and after the intervention. RESULTS: At the end of the study, the intervention group receiving MO capsules had a significant reduction in scores of depression, anxiety, stress, and total sleep disturbance, compared with the placebo group (P < 0.05). CONCLUSIONS: The results showed that 8-week supplementation with 3 g MO can decrease depression, anxiety, stress, and sleep disorder in patients with CSA.

Co-exposure to endocrine disruptors: effect of bisphenol A and soy extract on glucose homeostasis and related metabolic disorders in male mice.

OBJECTIVES: Bisphenol A (BPA) is a xenoestrogen, which is commonly used as a monomer of polycarbonate plastics food containers and epoxy resins. Little is known about the interaction effects between xeno- and phyto- estrogens on glucose homeostasis or other metabolic disorders. The aim of this study was to examine effects of individual or combined exposure to low doses of BPA and soy extract on glucose metabolism in mice with the goal to establish its potential mechanisms. METHODS: Fifty-four male mice were randomly divided into six groups. Mice were treated with soy extract at 60 or 150 mg/kg by daily gavage with or without subcutaneously administration of BPA (100 µg/kg/day) for four weeks at the same time, while the control group received a vehicle. Serum levels of fasting glucose, insulin, adiponectin, testosterone, malondialdehyde (MDA), and total antioxidant capacity (TAC) were measured. Homeostatic model assessment-ß cell function (HOMA-ß) index was also determined. RESULTS: BPA exposure induced hyperglycemia and significantly reduced HOMA-ß, serum levels of insulin, adiponectin, testosterone, and TAC and noticeably enhanced MDA in BPA group compared to control one. While treatment with soy extract in high dose (150 mg/kg) significantly decreased the levels of fasting blood glucose and MDA and notably improved the serum levels of insulin, HOMA-ß, and TAC compared to BPA group. CONCLUSION: Soy extract may protect against some adverse effects of BPA. These findings represent the first report suggesting a potential effect between soy extract and BPA in low doses, however, further studies are needed to confirm these results.