Synbiotic as an ameliorating factor in the health-related quality of life in women with polycystic ovary syndrome. A randomized, triple-blind, placebo-controlled trial.

BACKGROUND: There are complicated mechanisms that link the disruption of the gut microbiome to the symptoms and complications of polycystic ovary syndrome (PCOS). In this study, an attempt was made to assess the effects of synbiotics on the health-related quality of life (HRQoL) in women with PCOS . METHODS: Fifty-six women with PCOS were enrolled in a triple-blind controlled trial for 12 weeks. They were randomly assigned to receive a daily 2-gram synbiotic sachets (containing Bacillus coagulans (GBI-30), Lactobacillus rhamnosus, Lactobacillus helveticus, and fructooligosaccharide) (n = 28) or placebo (n = 28). To evaluate the impact on the HRQoL, participants were required to fill 26-Item Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ-26), 12-Item Short-Form Health Survey (SF-12) and Perceived Stress Scale (PSS-10) pre and post the intervention. RESULTS: Finally, statistical analyses were performed on 52 participants who finished the trial. Synbiotic supplementation improved the scores of emotional (P = 0.044), body hair (P = 0.016), weight (P = 0.033) and infertility domains (P = 0.027) of PCOSQ-26 compared to placebo group. The physical score within SF-12 also had a significant enhancement (P = 0.035). No significant improvement was seen in the PSS-10 score at the end of the trial. CONCLUSION: This study illustrated the advantageous effects of synbiotics on the health-related quality of life in women with PCOS. Further studies are required to confirm our findings. TRIAL REGISTRATION: http://www.irct.ir : IRCT20211108053007N1; date of registration: 14/02/2023.

The association between dietary nitrate, nitrite and total antioxidant capacity with cardiometabolic risk factors: a cross-sectional study among patients with type 2 diabetes.

Diabetes is a common, chronic, and complex disorder that leads to several disabilities and serious complications. Certain nutrients can be effective in the management of diabetes mellitus. In the present study, we aimed to investigate the effects of dietary nitrate, nitrite, dietary total antioxidant capacity (DTAC), and nitric oxide (NO) index on some cardiometabolic parameters in patients with diabetes. This cross-sectional study was conducted on 100 participants with type 2 diabetes. A validated, semi-quantitative, food frequency questionnaire was collected to evaluate dietary intakes. Anthropometric parameters, blood pressure, and biochemical parameters, including glycemic indices, lipid profile, high-sensitive C-reactive protein (hs-CRP), and serum NO were measured using standard methods. Higher intakes of nitrate and nitrite in our study were primarily attributed to drinking water, vegetables, grains (for nitrate), dairy products, and legumes (for nitrite) rather than higher meat intakes. After adjustment for total energy, MET, BMI, and age, higher intake of nitrate was related to lower HbA1C (p = 0.001) and hs-CRP (p = 0.0.23), and greater HDL-C (p < 0.001) and serum NO (p = 0.008). Moreover, a greater nitrite intake was associated with lower DBP (p = 0.017), HbA1C (p = 0.040), FPG (p = 0.011), and higher serum NO values (p = 0.001). Higher amounts of DTAC and NO index were also related to greater DBP (p < 0.001, and p = 0.004, respectively) and lower hs-CRP (p = 0.004, and p = 0.009, respectively). High intakes of dietary nitrate and nitrite, in the context of high DTAC, are significantly associated with the improvement of some cardiometabolic parameters in patients with diabetes.

A higher intake of nitrite is related to improving glycemic indices.A higher intake of nitrate is related to increasing HDL-C and decreasing hs-CRP.A higher intake of nitrate and nitrite, with a high DTAC index, is related to reduced cardiometabolic parameters.

Efficacy of the Synbiotic Supplementation on the Metabolic Factors in Patients with Metabolic Syndrome: A Randomized, Triple-Blind, Placebo-Controlled Trial.

Background: Metabolic syndrome is overwhelmingly increasing and is a significant risk factor for cardiovascular disorder, so effective treatment strategies are considered high priority. This study aimed to determine the effects of synbiotic supplementation on metabolic factors in patients with metabolic syndrome. Methods: In this triple-blind, randomized, placebo-controlled, clinical trial, 108 participants were divided into two groups to receive synbiotic supplementation or placebo for 12 weeks. All participants were also educated about maintaining a healthy lifestyle and consuming low-calorie nutritious meals, along with dietary intake and physical activity monitoring. Anthropometric measures, blood pressure, glycemic indices, lipid profile, hepatic enzymes, and hs-CRP were evaluated at the baseline and end of the trial. Results: Synbiotic supplementation significantly reduces fasting blood glucose (FBG) levels in the intervention group versus placebo group [-14.69 ± 15.11 mg/dl vs. -8.23 ± 7.90 mg/dl; p=0.007], but there was no difference between groups in other metabolic factors. Conclusions: These findings suggest that synbiotic supplementation while following a healthy lifestyle and nutrition improved FBG in patients with metabolic syndrome.

Growth and Nutritional Status of Phenylketonuric Children and Adolescents.

BACKGROUND: The goal of this study was to assess the anthropometric and biochemical parameters of children and adolescents with phenylketonuria (PKU). METHODS: The participants in this cross-sectional study ranged in age from four to 18 years old. Biochemical markers such as vitamin B12, folic acid, iron, ferritin, calcium, 25-hydroxy vitamin D3, zinc, plasma phenylalanine (Phe) and tyrosine (Tyr) levels in blood were evaluated, as well as demographics and anthropometric measurements. A three-day dietary recall questionnaire was completed by all individuals. RESULTS: 80% (64) of the 80 patients (42 females, 52.5%) had typical PKU. Consanguineous marriages were found in 57.5% (46) of the patients' parents. According to the height for age index, 17.5% of the study group (n = 14) were short or very short. According to age-related weight and body mass index (BMI), 37.5% (n = 30) and 43.8% (n = 35) of people are obese or overweight, respectively. Biochemical tests revealed increased vitamin B12 levels and 25-hydroxy vitamin D3 deficiency in 35% (n = 28) of the patients, insufficient folic acid in 12.5% (n = 10), and elevated phenylalanine levels in 70.3% (n = 45) of children under 12 years old, and adolescents 62.5% (n = 10). A high Phe intake (OR = 4.44, CI %95 = 1.27-15.57) is a risk factor for obesity and overweight. CONCLUSION: Patients with PKU had a high rate of overweight and obesity. PKU patients who are overweight or obese do not differ from normal-weight patients in terms of dietary intake or laboratory findings (except for serum iron levels). One-third of patients with phenylketonuria were vitamin D deficient and had a BMI/A index of overweight/obese. It is recommended to use special medical food to help solve energy and nutrient deficiencies.

Diet-dependent acid load and the risk of colorectal cancer and adenoma: a case-control study.

OBJECTIVES: Colorectal cancer (CRC) is the third and second most prevalent cancer in men and women, respectively. Various epidemiological studies indicated that dietary factors are implicated in the aetiology of CRC and its precursor, colorectal adenomas (CRA). Recently, much attention has been given to the role of acid-base balance in the development of chronic diseases including cancers. Therefore, the aim of the current study is to examine the association of diet-dependent acid load and the risk of CRC and CRA. DESIGN: In this case-control study, potential renal acid load (PRAL) was computed based on dietary intake of participants assessed via a validated FFQ. Negative PRAL values indicated a base-forming potential, while positive values of PRAL implied acid-forming potential of diet. Logistic regression was used to derive OR and 95 % CI after adjusting for confounders. SETTING: Tehran, Iran. PARTICIPANTS: A total of 499 participants aged 30-70 years were included in the study (240 hospital controls, 129 newly diagnosed CRC and 130 newly diagnosed CRA). The current study was conducted between December 2016 and September 2018. RESULTS: After adjusting for potential confounders, a higher PRAL was associated with increased odds of CRC and CRA. The highest v. the lowest tertile of PRAL for CRC and CRA was OR 4·82 (95 % CI 2·51-9·25) and OR 2·47 (95 % CI 1·38-4·42), respectively. CONCLUSIONS: The findings of the current study suggested that higher diet-dependent acid load is associated with higher risk of CRC and CRA.

Dietary intake of polyphenols and total antioxidant capacity and risk of prostate cancer: A case-control study in Iranian men.

BACKGROUND: Prostate cancer (PCa) is one of the leading causes, globally, of cancer-related mortality. Previous studies have reported an inverse relationship between some food items or dietary patterns and prostate cancer risk. Polyphenols, as antioxidant and anti-inflammatory dietary components, have been associated with a reduced risk of PCa, whilst dietary indices such as total antioxidant capacity are good predictors of PCa risk. OBJECTIVE: The purpose of this study was to conduct a case-control study on the association between polyphenol intake and DTAC (dietary total antioxidant capacity) and PCa risk in men. METHOD: 205 hospital-based controls and 97 newly diagnosed PCa patients were asked about their dietary intakes using a validated questionnaire. The polyphenol contents (flavonoids, lignans, stilbenes and phenolic acids) of foods and beverages were calculated. TAC was obtained using a comprehensive database consisting of the total antioxidant content of more than 3000 food and beverages. Logistic regression was used to determine the odds ratios (OR), with 95% confidence intervals (CI), of PCa according to categories of polyphenol intake and TAC. RESULTS: When comparing the highest and the lowest tertile of total polyphenol (OR: 0.12; 95% CI: 0.03-0.41), lignans (OR: 0.14; 95% CI: 0.04-0.41), phenolic acids (OR: 0.18; 95% CI: 0.05-0.57) and some flavonoid subgroups intake including flavan-3-ols (OR: 0.24; 95% CI: 0.08-0.67), flavanones (OR: 0.10; 95% CI: 0.03-0.31) and flavones (OR: 0.33; 95% CI: 0.12-0.87), we observed a significant decreasing trend in the risk of PCa (p for trend<0.05). CONCLUSION: The results suggest that the consumption of some polyphenols can significantly reduce the risk of PCa.

Correlation of Low Levels of α-1 Antitrypsin and Elevation of Neutrophil to Lymphocyte Ratio with Higher Mortality in Severe COVID-19 Patients.

BACKGROUND: Variations in COVID-19 prevalence, severity, and mortality rate remain ambiguous. Genetic or individual differences in immune response may be an explanation. Moreover, hyperinflammation and dysregulated immune response are involved in the etiology of severe forms of COVID-19. Therefore, the aim of the present study was to analyze serum alpha-1 antitrypsin (AAT) levels, as an acute-phase plasma protein with immunomodulatory effect and neutrophil to lymphocyte ratio (NLR) as a marker of inflammation response in severe COVID-19 illness. METHODS: In this retrospective observational cohort study, 64 polymerase chain reaction (PCR) positive COVID-19 hospitalized patients were studied for AAT, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), troponin, complete blood count (CBC), random blood sugar, serum glutamate oxaloacetate transaminase (SGOT), serum glutamate pyruvate transaminase (SGPT), and arterial oxygen saturation (O2sat) at admission and during hospitalization. RESULTS: The results showed that hospitalized patients with COVID-19 had low serum levels of AAT and high CRP levels at the first days of hospitalization. In particular, the percentages of individuals with low, normal, and high AAT levels were 7.80%, 82.80%, and 9.40%, respectively, while high and low values of CRP accounted for 86.70% and 13.30% of patients. Most of the patients had an upward neutrophil to lymphocyte ratio (NLR) trend, with a higher mortality rate (p < 0.05) and troponin levels (p < 0.05). However, comorbidities, CRP alterations, ESR alterations, nonfasting blood sugar, SGOT, SGPT, O2sat, RBC, and PLT values were not significantly different between the NLR downward and upward trend groups. CONCLUSIONS: The current study revealed that severe COVID-19 patients had low serum AAT levels related to CRP values. Therefore, AAT response may be considered as a new mechanism by which some COVID-19 patients show immune dysregulation and more severe symptoms.

Inflammatory markers response to crocin supplementation in patients with type 2 diabetes mellitus: A randomized controlled trial.

Inflammation and oxidative stress is a risk factor for the development of long-term consequences in patients with type 2 diabetes mellitus (T2DM). This study was designed to investigate the effects of crocin consumption on oxidative stress and inflammatory markers in patients with T2DM. In this clinical trial with a parallel-group design, 50 patients with T2DM were randomly assigned to either the crocin or the placebo group. The crocin group received 15 mg crocin twice daily, whereas the placebo group received corresponding placebos. At baseline and the end of week 12, serum high sensitive C-reactive protein (hs-CRP), interleukin-6 (IL-6), tumor necrosis factor-ɑ (TNF-ɑ), nuclear factor-κB (NF-κB), and malondialdehyde (MDA) were measured. Compared with placebo group, crocin reduced hs-CRP (-1.03 vs. 1.42, p = .007), TNF-ɑ (-0.8 vs. 0.28, p = .009), and NF-κB (-0.39 vs. 0.01, p = .047) after 12 weeks intervention; these improvements were also significant in comparison with the baseline values. Plasma IL-6 decreased significantly in the crocin group at the end of week 12 compared to baseline (p = .037), whereas no significant change was observed in the placebo group. Plasma concentration of MDA did not change within and between groups after intervention. This study indicates that daily administration of 30 mg crocin supplement to patients with T2DM reduces the concentrations of hs-CRP, TNF-ɑ, and NF-κB which are involved in the pathogenesis of complications of T2DM.

The effects of nano-curcumin supplementation on glycemic control, blood pressure, lipid profile, and insulin resistance in patients with the metabolic syndrome: A randomized, double-blind clinical trial.

Metabolic syndrome (MetS) is one of the most important health hazards. Curcumin is extracted from Curcuma longa (turmeric), which can affect the components of MetS. To increase the oral bioavailability of curcumin, nano-micelle curcumin is used instead of curcumin powder. In this randomized, double-blind, controlled clinical trial, 50 patients with MetS were randomly assigned to two groups to receive either 80 mg/day nano-curcumin (n = 25) or placebo (n = 25), for 12 weeks anthropometric measurements, blood pressure, and biochemical factors-including fasting blood sugar (FBS), Hemoglobin A1c (HbA1c), homeostatic model assessment (HOMA) for insulin resistance (HOMA-IR), pancreatic ß cell function (HOMA-ß) and lipid profile-were assessed at the baseline and the end of the study. Statistical analyses were done using SPSS software (Version 23). The analysis between the two groups has illustrated a significant reduction in the average change of triglyceride (TG) levels (-60.5 ± 121.7 vs. 13.1 ± 78.1 mg/dL; p < .05) and HOMA-ß (-5.7 ± 48.2 vs. -4.01 ± 16.9; p < .05). But there were no significant differences in anthropometric measurements, blood pressure and biochemical factors-including FBS, HbA1c, HOMA-IR, HOMA-ß, and lipid profile variables include (total cholesterol, LDL-C, and HDL-C) at the end of the study. In conclusion, supplementation with nano-micelle curcumin significantly improved serum TG in MetS patients.

Is Bacillus coagulans supplementation plus low FODMAP diet superior to low FODMAP diet in irritable bowel syndrome management?

PURPOSE: The aim of this study was to assess the superiority of low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) diet plus Bacillus coagulans supplementation to low FODMAP diet alone in the reduction of irritable bowel syndrome (IBS) symptoms. METHODS: In this randomized clinical trial, fifty IBS patients who met Rome IV criteria for IBS were randomly assigned to receive a low FODMAP diet plus either a probiotic or a placebo capsule for 8 weeks. Probiotic capsules contained 109B. coagulans spores and 400 mg inulin, while placebo capsules consisted of 500 mg rice starch. RESULTS: Significant improvements were observed in abdominal pain intensity and frequency, abdominal distension, satisfaction with bowel habits, quality of life, defecation consistency, and patient-reported severity score in both groups; however, only improvement in severity score was significantly higher in probiotic group compared with placebo group (P = 0.001). Moreover, the frequency of patients with clinical improvement in IBS-symptom severity scale (IBS-SSS) was significantly more in probiotic group compared to placebo group (P = 0.038). CONCLUSION: Our results indicate that the addition of probiotic supplement containing B. coagulans to the low FODMAP diet might be superior to low FODMAP diet in alleviating IBS symptoms.

The effects of curcumin supplementation on high-sensitivity C-reactive protein, serum adiponectin, and lipid profile in patients with type 2 diabetes: A randomized, double-blind, placebo-controlled trial.

Diabetes mellitus is one of the most common and important metabolic diseases in human. Curcumin, which is a natural polyphenol found in turmeric, can be used in treatment of diabetes complications for its antidiabetic, anti-inflammatory, and antioxidant properties. In this double-blind randomized clinical trial, 44 patients with Type 2 diabetes randomly assigned to curcumin or placebo group. Patients consumed either 1,500-mg curcumin or placebo daily for 10 weeks. Anthropometric measurements were measured at baseline and at the end of the study. Serum concentrations of triglyceride (TG), total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, high-sensitivity C-reactive protein, and adiponectin were determined after 12-hr fasting at the beginning and end of study. The mean serum level of TG decreased in curcumin group compared with baseline (109 ± 36 vs. 124 ± 36; p < 0.05). At the end of study, the mean concentration of high-sensitivity C-reactive protein decreased in the curcumin group compared to the control (2.9 ± 2.9 vs. 3.4 ± 4.2; p < 0.05). The mean serum concentration of adiponectin increased (64 ± 3 vs. 63 ± 4; p < 0.05) in the treatment group compared with the placebo at the end of the study. The results of the current study indicate that curcumin consumption may reduce diabetes complications through decreasing TG level as well as indicators of inflammation.

Effects of green coffee extract supplementation on anthropometric indices, glycaemic control, blood pressure, lipid profile, insulin resistance and appetite in patients with the metabolic syndrome: a randomised clinical trial.

This study was conducted to elucidate the effects of decaffeinated green coffee bean extract (GCE) on anthropometric indices, glycaemic control, blood pressure, lipid profile, insulin resistance and appetite in patients with the metabolic syndrome (Mets). Subjects were randomly allocated to consume 400 mg GCE or placebo capsules twice per d for 8 weeks. Both groups were advised to follow an energy balanced diet. After GCE supplementation, systolic blood pressure (SBP) significantly reduced compared with the placebo group (-13·76 (sd 8·48) v. -6·56 (sd 9·58) mmHg, P=0·01). Also, GCE treatment significantly reduced fasting blood glucose (FBS) (-5·15 (sd 60·22) v. 29·42 (sd 40·01) mg/dl (-0·28 (SD 3·34) v. 1·63 (SD 2·22) mmol/l); P=0·03) and homoeostatic model of assessment of insulin resistance in comparison to placebo (-1·41 (sd 3·33) v. 1·23 (sd 3·84), P=0·02). In addition, waist circumference (-2·40 (sd 2·54) v. -0·66 (sd 1·17) cm, P=0·009) and appetite score (-1·44 (sd 1·72) v. -0·2 (sd 1·32), P=0·01) of the individuals supplemented with GCE indicated a significant decline. Besides, weight and BMI reduction in the intervention group was almost twice as much as the placebo group; however, this discrepancy was marginally significant (weight: -2·08 (sd 2·11) v. -0·92 (sd 1·30) kg, P=0·05). No difference was observed in terms of glycated Hb (HbA1c) percentage and lipid profile parameters between the two groups. To sum up, GCE administration had an ameliorating effect on some of the Mets components such as high SBP, high FBS and Mets main aetiological factors including insulin resistance and abdominal obesity. Furthermore, GCE supplementation could reduce appetite level.

Effects of pomegranate juice consumption on oxidative stress in patients with type 2 diabetes: a single-blind, randomized clinical trial.

Increased free radicals production due to hyperglycemia produces oxidative stress in patients with diabetes. Pomegranate juice (PJ) has antioxidant properties. This study was conducted to determine the effects of PJ consumption in oxidative stress in type 2 diabetic patients. This study was a randomized clinical trial performed on 60, 40-65 years old diabetic patients. The patients were randomly allocated either to PJ consumption group or control. Patients in PJ group consumed 200 ml of PJ daily for six weeks. Sex distribution and the mean age were not different between two groups. After six weeks intervention, oxidized LDL and anti-oxidized LDL antibodies decreased and total serum antioxidant capacity and arylesterase activity of paraoxonase increased significantly in the PJ-treated group compared to the control group. Our data have shown that six weeks supplementation of PJ could have favorable effects on oxidative stress in patients with type 2 diabetes (T2D).

Effects of pomegranate juice consumption on inflammatory markers in patients with type 2 diabetes: A randomized, placebo-controlled trial.

BACKGROUND: Diabetes causes the increased concentration of circulatory cytokines as a result of inflammation. Considering that pomegranate juice (PJ) is known to have antioxidant and anti-inflammatory properties, the purpose of this study was to determine the effects of PJ consumption on markers of inflammation in patients with type 2 diabetes (T2D). MATERIALS AND METHODS: In a randomized, double-blind clinical trial study, 50 patients with T2D (40-65 years old) were randomly assigned to one of two groups. Participants in each group received either 250 mL/day PJ or a control beverage for 12 weeks. Biochemical markers including fasting plasma glucose (FPG), insulin and inflammatory markers were assayed on the baseline and follow-up blood samples. RESULTS: In all, 44 patients in two groups were included in the analysis: PJ (n = 22) and placebo (n = 22). After 12 weeks of intervention, in the PJ group, there were 32% and 30% significant decreases in plasma C-reactive protein (hs-CRP) and Interlukin-6, respectively (P < 0.05). The mean ± SD plasma interlukin-6 (7.1 ± 5.6 vs. 11.9 ± 14.4 mg/L) and hs-CRP (1791 ± 1657 and 1953 ± 1561 ng/mL) concentrations in the PJ group were significantly lower than the placebo group after intervention (P < 0.05). CONCLUSION: PJ consumption by patients with T2D does not affect FPG or the insulin resistance index (HOMA-IR), whereas it does reduce Interlukin-6 and hs-CRP concentrations in plasma. Therefore, PJ consumption may have an anti-inflammatory effect in patients with T2D.

Dietary polyphenols and metabolic syndrome among Iranian adults.

AIM: The aim of this study was to investigate the association between total polyphenol intake, its subclasses (including flavonoids, phenolic acids, stilbenes and lignans), and the metabolic syndrome (MetS). METHODS: This population-based cross-sectional study was conducted on a representative of 2618 adults, aged 19 to 84 years. Dietary intake was assessed using a validated food-frequency questionnaire and intakes of total polyphenol and four main subclasses of polyphenol including flavonoids, phenolic acids, stilbenes and lignans were determined. RESULTS: Higher consumption of flavonoid intakes was associated with lower odds of enlarged waist circumference, hypertriglyceridemia, low HDL cholesterol, hyperglycemia, hypertension and MetS. Subjects in the highest quartile of lignan intakes had higher odds of having hypertriglyceridemia and hyperglycemia. Subjects in the highest quartile of stilbene intakes had higher odds of having hypertension. CONCLUSION: Intakes of selected subclasses of polyphenol such as flavonoids are associated with a lower prevalence of MetS among Tehranians.

Effects of concentrated beetroot juice consumption on glycemic control, blood pressure, and lipid profile in type 2 diabetes patients: randomized clinical trial study.

BACKGROUND: While the prevalence of type 2 diabetes (T2D) is growing worldwide, dietary intake plays a remarkable role in the management of disease complications. Evidence suggests that beetroot has health-promoting potentials, including anti-inflammatory, antioxidant, and antidiabetic properties. Therefore, the present clinical trial aimed to investigate the effects of concentrated beetroot juice (BJ) supplementation on anthropometric measures, glycemic control, blood pressure (BP), and lipid profile in T2D patients. METHODS: In the simply randomized, parallel-group, controlled, and open-label trial, forty-six patients with T2D were randomly allocated to either the intervention group (BJ group), who consumed 24 ml concentrated BJ daily for 12 weeks, or the control group without any intervention. Anthropometric measurements, physical activity, dietary intakes, glycemic measures, lipid profile, and blood pressure were assessed at the baseline and the end of the study. RESULTS: Plasma nitric oxide (NO) in the intervention group had a higher nonsignificant increase after 12 weeks compared with the control group (8.57 ± 23.93 vs. 2.31 ± 15.98, P = 0.128). Compared with the baseline, significant reductions in plasma insulin (14.55 ± 7.85 vs. 10.62 ± 6.96, P = 0.014) and homeostasis model assessment of ß-cell function (HOMA-B) (3.96 ± 0.83 vs. 3.63 ± 0.75, P = 0.038), as well as a marginally significant reduction in high-density lipoprotein cholesterol (HDL-C) (70.81 ± 11.24 vs. 65.44 ± 6.46, P = 0.058) were observed in the control group after 12 weeks. Diastolic blood pressure (DBP) was significantly reduced in the BJ group compared with the baseline (74.73 ± 16.78 vs. 72.36 ± 16.09, P = 0.046). After adjusting for baseline values, no significant effect on the levels of fasting plasma glucose (FPG), insulin, hemoglobin A1c (HgA1c), HOMA-ß, homeostatic model assessment for insulin resistance (HOMA-IR), total cholesterol (TC), low-density lipoprotein (LDL), HDL, triglycerides (TG), and blood pressure (BP) was observed. CONCLUSIONS: Our study showed that daily consumption of 24 ml concentrated BJ did not affect the levels of glycemic measures, blood pressure, and lipid profile. More studies are necessary to confirm these findings. TRIAL REGISTRATION: This present clinical trial has been registered in the Iranian Registry of Clinical Trials with registration number IRCT20150815023617N5.

The effects of rice bran supplementation for management of blood lipids: A GRADE-assessed systematic review, dose-response meta-analysis, and meta-regression of randomized controlled trials.

BACKGROUND: We aimed to conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) to investigate the effects of rice bran supplementation on serum lipid profile levels. METHODS: We searched PubMed/Medline, Scopus, ISI Web of Science, and Google Scholar using related keywords. Published RCTs exploring the effects of rice bran consumption on lipid profile were searched up to June 2022. Evidence certainty was assessed on the basis of the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. The data were pooled using a random-effects model and reported as weighted mean difference (WMD) and 95% confidence interval (CI) for each outcome. RESULTS: Meta-analysis of eight RCTs (with 11 effect sizes) showed no significant effect of rice bran supplementation on serum levels of triglyceride (WMD: -11.38 mg/dl; 95% CI: -27.73, 4.96; P = 0.17), total cholesterol (WMD: -0.68 mg/dl; 95% CI: -7.25, 5.88; P = 0.834), low-density lipoprotein cholesterol (WMD: -1.68 mg/dl; 95% CI: -8.46, 5.09; P = 0.627) and high-density lipoprotein cholesterol (WMD: 0.16 mg/dl; 95% CI: -1.52, 1.85; P = 0.848) compared to control group. CONCLUSION: Our meta-analysis suggests that rice bran supplementation has no significant effects on serum levels of lipid profile components. However, larger studies with longer durations and improved methodological quality are needed before firm conclusions can be reached.

Effects of Synbiotic-Containing Bacillus coagulans (GBI-30) on the Cardiovascular Status of Patients With Polycystic Ovary Syndrome: A Triple-blinded, Randomized, Placebo-controlled Study.

PURPOSE: Despite the high risk of cardiovascular diseases in women with polycystic ovary syndrome, fewer studies have addressed the improvement of cardiometabolic status of these patients. This study was conducted with the aim of investigating the effects of synbiotic-containing, spore-forming Bacillus coagulans on cardiometabolic indicators, including lipid profile, C-reactive protein, and atherogenic indexes in patients with polycystic ovary syndrome. METHODS: In the present 12-week, triple-blinded, randomized, placebo-controlled clinical trial, 72 women with polycystic ovaries were randomized to receive either 2 g of synbiotic sachet (n = 36) or placebo (n = 36) plus lifestyle modification. Fasting blood samples were taken before and after the intervention. FINDINGS: Statistical analysis was performed in 60 participants with a mean (SD) age of 28.25 (5.98) years who completed the intervention (synbiotic group [n = 34] and placebo group [n = 26]). A significant mean (SD) decrease in C-reactive protein level was observed in the synbiotic group compared with the placebo group (-0.12 [9.57] v. -0.008 [4.69], P = 0.03). No significant differences in mean changes of lipid profile and atherogenic indexes were seen between the 2 groups. Although the estimated mean changes in atherogenic indexes in the synbiotic group indicates a greater reduction than the placebo group, no significant difference was detected. IMPLICATIONS: Our 12-week synbiotic intervention improved the inflammatory status in women with polycystic ovaries without affecting lipid profile or atherogenic indexes.

Does symbiotic supplementation which contains Bacillus Coagulans Lactobacillus rhamnosus, Lactobacillus acidophilus and fructooligosaccharide has favourite effects in patients with type-2 diabetes? A randomised, double-blind, placebo-controlled trial.

This study aimed to determine the effect of Bacillus Coagulans symbiotic supplementation on metabolic factors and inflammation in patients with type-2 diabetes. In this clinical trial, 50 patients with type-2 diabetes were randomly assigned to the symbiotic (containing Bacillus Coagulans + Lactobacillus rhamnosus + Lactobacillus acidophilus and fructooligosaccharide) or placebo groups to receive one sachet daily for 12 weeks. Glycaemic Index, lipid profile, and hs-CRP were measured at the beginning and end of the study. Analysis of covariance demonstrated that fasting blood glucose (FBG), insulin, homeostatic Model Assessment for Insulin Resistance (HOMA-IR), ß-cell function (HOMA-ß) (p <.05) and hs-CRP (p <.05) significantly declined in the treatment group compared with the placebo group. So, the current study indicated that Bacillus Coagulans symbiotic supplementation could improve metabolic factors and inflammation in patients with type-2 diabetes.

A randomized clinical trial of beetroot juice consumption on inflammatory markers and oxidative stress in patients with type 2 diabetes.

Oxidative stress and chronic inflammation are both major underlying factors for the initiation and progression of diabetes, as well as for the development of long-term diabetes-related consequences in patients with type 2 diabetes mellitus (T2DM). This study was designed to evaluate the effects of beetroot juice (BJ) consumption on oxidative stress and inflammatory markers in patients with T2DM. In this trial, 52 patients with T2DM were randomly assigned to either the concentrated BJ or the control group. The BJ group received 12 ml concentrated BJ twice daily, whereas the control group received no intervention. At the baseline and the end of week 12, plasma levels of malondialdehyde (MDA), high sensitive C-reactive protein (hs-CRP), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and nuclear factor-κB (NF-κB) were measured. Compared with the control group, BJ reduced IL-6 (-0.1 vs. 0.83, P = 0.001), TNF-α (-1.28 vs. 5.51, P = 0.001), and NF-κB (-0.03 vs. 0.36, P = 0.005) after 12-week intervention; plasma concentration of MDA and hs-CRP did not change between groups after intervention. Intra-group comparison disclosed that daily BJ consumption could not change oxidative stress and inflammatory markers except for TNF-α (-1.28 ± 2.31, P = 0.026) compared with the baseline. However, the concentrations of IL-6, TNF-α, and NF-κB increased significantly in the control group at the end of week 12 compared to baseline (19.5%, P = 0.001; 120%, P = 0.001; and 69%, P = 0.021, respectively). In conclusion, our study indicates that daily consumption of BJ reduces the concentrations of some inflammatory markers, including IL-6, TNF-α, and NF-κB, which are involved in the pathogenesis of complications of T2DM. PRACTICAL APPLICATION: Beetroot juice concentrate contains nutrients such as antioxidants that can improve the health status of people with type 2 diabetes.