The effects of soymilk plus probiotics supplementation on cardiovascular risk factors in patients with type 2 diabetes mellitus: a randomized clinical trial.

OBJECTIVE: Type 2 diabetes mellitus (T2DM) is associated with an increased risk of cardiovascular diseases. This study aimed to assess the effects of soymilk plus probiotics co-administration on cardiovascular risk factors in T2DM patients. METHODS: One hundred patients with T2DM (aged 40-75 years old) were randomly assigned into 4 groups (soymilk + probiotics supplement, soymilk + placebo, conventional milk + placebo, and probiotics supplement) for 6 weeks. Standard protocols were followed for the collection of fasting blood samples, dietary intakes, and anthropometric measurements. RESULTS: It was shown that soymilk + probiotics consumption significantly decreased diastolic blood pressure (DBP) (p = 0.001), triglycerides (TG) (P < 0.001), total cholesterol (TC) (p < 0.01), and insulin (P < 0.003) levels and significantly increased high-density lipoprotein cholesterol (HDL-C) (P = 0.002) levels. Soymilk + placebo administration significantly decreased DBP (p = 0.01), insulin (p = 0.006), and TG (p = 0.001) levels and significantly increased HDL-C (p = 0.03) levels. A significant decrease in insulin (p = 0.003) and systolic blood pressure (SBP) (p = 0.01) levels and an increase in HDL-C (p = 0.04) levels were observed after supplementation with probiotics. Findings from between-group comparisons showed a significant decrease in SBP levels in the probiotics supplement group compared to conventional milk group (p < 0.05). CONCLUSION: Soymilk and probiotics consumption might improve some cardiovascular risk factors in patients with T2DM. However, possible synergic effects while consumption of soymilk plus probiotics supplement didn't show in this study which warranted further research.

A comparison of the effects of cinnamon, ginger, and metformin consumption on metabolic health, anthropometric indices, and sexual hormone levels in women with poly cystic ovary syndrome: A randomized double-blinded placebo-controlled clinical trial.

Background/objectives: Polycystic ovary syndrome (PCOS) is a prevalent endocrine disorder in women that can alter blood glucose, lipid profile and sexual hormonal level. Therefore, the evaluation of potential therapeutic agents in this population is important. The aim of the study was to determine the effects of cinnamon, ginger, and metformin intake on improvement of sex hormones level, metabolic health (lipid profiles, insulin level and fasting blood glucose) and anthropometric indices (weight, body mass index (BMI), etc.) in women with PCOS. Methods: A total of 100 women with PCOS were randomly assigned to one of the following four groups: cinnamon (500 mg of cinnamon, 3 × day), ginger (500 mg of ginger, 3 × day), metformin (500 mg of metformin 3 × day) or placebo. However, 17 participants were excluded for various reasons and consequently, 83 participants were considered for analysis. Sexual hormones, anthropometrics, glycemic and lipid markers were evaluated before and after the 8-week intervention. Results: Weight and BMI decreased significantly in all intervention groups. The consumption of metformin and cinnamon significantly decreased insulin resistance (HOMA-IR) in comparison to the placebo and ginger groups (P < 0.05). Moreover, a significant decrease in FSH (follicle-stimulating hormone) and LH (Luteinizing hormone) levels were observed in the ginger compared to the placebo group. While metformin and cinnamon significantly lowered testosterone levels (P < 0.05), none of the groups experienced a significant change in DHEA (dehydroepiandrosterone). Conclusion: Our findings suggest that in women with PCOS, cinnamon supplementation causes similar reductions in insulin resistance and testosterone level to that of metformin. Ginger supplementation decreased FSH and LH, hormonal effects not seen following metformin consumption. Overall, cinnamon and ginger supplementations may potentially be used as alternative treatment in women with PCOS. Clinical trial registration: [https://www.irct.ir/trial/28548], identifier [IRCT20171227038105N1].

Evaluating the effects of dark chocolate formulated with micro-encapsulated fermented garlic extract on cardio-metabolic indices in hypertensive patients: A crossover, triple-blind placebo-controlled randomized clinical trial.

This study aimed to investigate the health-related effects of microencapsulated fermented garlic extract (FGE) containing dark chocolate in hypertensive adults. For this purpose, 36 hypertensive adults (15 males vs. 21 females) were randomized to receive the FGE (5 g/day) dark chocolate containing 650 mg of FGE powder or the placebo. Intervention periods lasted for 6 weeks and were separated by a 3-week wash-out period. The response variables included blood pressure, anthropometric indices, lipid profile, and inflammatory and oxidative stress indices. Statistical analyses were performed using the Pkcross procedure, and Cohen's d was estimated for all response variables. There was no significant inter-period difference between the mean changes of body weight, waist circumference, and body mass index (BMI). Furthermore, no significant change was confirmed in participants' blood pressure, triglycerides, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), very low-density lipoprotein (VLDL), serum homocysteine, high-sensitive c-reactive protein (hs-CRP), malondialdehyde (MDA), and total antioxidant capacity (TAC). It seems that the dose of FGE used in this study was not sufficient to cause any significant changes in the outcomes. Therefore, further studies with dose-response designs and longer durations are recommended.

Antihypertensive and antihyperlipemic of spirulina (Arthrospira platensis) sauce on patients with hypertension: A randomized triple-blind placebo-controlled clinical trial.

Systemic arterial hypertension is an independent risk factor for coronary heart disease, stroke, heart failure, and chronic kidney diseases. Spirulina is microalgae with nutritious ingredients and has potential attenuating effects on chronic diseases including hypertension. Spirulina can be added to food products in order to develop functional foods. The aim of this study was to assess the effects of 8-week consumption of a salad dressing containing 2 g of spirulina platensis powder versus a placebo dressing on patients with hypertension. In this triple-blind randomized clinical trial, 48 patients with hypertension were enrolled to receive daily either spirulina-fortified dressing or placebo for 2 months. A total of 41 patients completed this study. We observed that the consumption of spirulina dressing significantly reduced systolic blood pressure (p = .02), diastolic blood pressure (p = .03), serum triglyceride (p = .01), total cholesterol, and low-density lipoprotein (LDL) levels, compared to nonsignificant changes in the placebo group. Significant changes in TAC and hs-CRP levels were observed in none of the groups. According to our findings, spirulina-fortified dressing as a functional food can be used a supportive treatment for patients with hypertension along with standard antihypertensive drugs. However, further investigations are required for a more comprehensive conclusion.

Effect of Artemisia extract on glycemic control: A systematic review and meta-analysis of randomized controlled trial.

BACKGROUND AND AIM: Animal and human studies have indicated anti-diabetic effect of Asteraceae. The present study aimed to systematically review and analyse randomized controlled trials assessing the effect of Artemisia extract on glycemic status in patients with impaired glycemic control. METHODS: Web of Science, Cochrane library, EMBASE and PubMed databases were searched from the earliest possible date up to 7th October 2020. RESULTS: Six studies were included in the meta-analysis. Analysis showed that supplementation with Artemisia extract decreased homeostatic model assessment of insulin resistance (HOMA-IR) (-0.734, 95% CI: -1.236 to -0.232, P = .019) in comparison to placebo. However, reductions in fasting blood glucose (FBG) (-0.595, 95% CI: -1.566 to 0.376, P = .164), insulin (-0.322, 95% CI: -1.047 to 0.404, P = .286) and glycated haemoglobin (-0.106, 95% CI: -0.840 to 0.629, P = .678) were not statistically significant. CONCLUSION: Supplementation with Artemisia extract may reduce HOMA-IR, but beneficial effects on other markers such as FBG requires further investigations.

Dietary Intakes of Zinc, Copper, Magnesium, Calcium, Phosphorus, and Sodium by the General Adult Population Aged 20-50 Years in Shiraz, Iran: A Total Diet Study Approach.

In the present total diet study, the dietary intake of zinc (Zn), copper (Cu), magnesium (Mg), calcium (Ca), phosphorus (P), and sodium (Na) by healthy adults in Shiraz, Iran, was estimated from the foods as consumed. A total of 580 individual food items were collected, prepared, and pooled into 129 composite samples. The metal concentration was then evaluated using inductively coupled plasma-optical emission spectrometry. The mean intakes of Zn (12.92 mg/d), Cu (3.80 mg/d), and Mg (412.68 mg/d) exceeded the estimated average requirements (EARs), but they were well below the upper limits. A high prevalence of inadequate intake was observed for Ca (91.6%) and P (89.7%), which was mainly due to nutritionally imbalanced diets. Sodium intake for average and high consumers (97.5th percentile) was 123.6% and 237.8% of the tolerable upper intake level of 2300 mg/d, respectively, with 70% of the participants having intakes higher than this threshold value. Nutrition education, nutritional rehabilitation, Ca supplementation, food fortification, mandatory reduction of salt content in processed foods, and discretionary salt use (in home cooking or at the table) are among the possible strategies that can be adopted to combat the health problems.

Effects of green tea or green tea catechin on liver enzymes in healthy individuals and people with nonalcoholic fatty liver disease: A systematic review and meta-analysis of randomized clinical trials.

The therapeutic potential of green tea as a rich source of antioxidants and anti-inflammatory compounds has been investigated by several studies. The present study aimed to systematically review and analyze randomized clinical trials (RCTs) assessing the effects of green tea, catechin, and other forms of green tea supplementation on levels of liver enzymes. PubMed, SCOPUS, EMBASE, and Cochrane databases were searched until February 2019. All RCTs investigating the effect of green tea or its catechin on liver enzymes including alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and bilirubin were included. A total of 15 RCTs were included. The overall effect of green tea on liver enzymes was nonsignificant (ALT [Standardized mean difference (SMD)= -0.17, CI -0.42 to 0.08, p = .19], AST [SMD = -0.07, CI -0.43 to 0.29, p = .69], and ALP [SMD = -0.17, CI -0.45 to 0.1, p = .22]). However, subgroup analyses showed that green tea reduced the levels of liver enzymes in participants with nonalcoholic fatty liver disease (NAFLD) but in healthy subjects, a small significant increase in liver enzymes was observed. In conclusion, the results of this study suggest that the effect of green tea on liver enzymes is dependent on the health status of individuals. While a moderate reducing effect was observed in patients with NAFLD, in healthy subjects, a small increasing effect was found.

Effect of probiotic and synbiotic supplementation on inflammatory markers in health and disease status: A systematic review and meta-analysis of clinical trials.

The current systematic review and meta-analysis investigated the effect of probiotic/synbiotic on a wide range of inflammatory and anti-inflammatory markers in healthy and various disease conditions. PubMed, SCOPUS and Web of Science databases were searched. All clinical trials which investigated the effect of oral administration of probiotic or synbiotic on inflammatory markers (C-reactive protein (CRP), interleukin (IL) 1ß, IL-4, IL-6, IL-8, IL-10, IL-12, tumor necrosis factor (TNF) α, interferon (IFN) γ and transforming growth factor (TGF) ß) for more than one week with concurrent control groups were included. One-hundred sixty seven publications was analysed. Results were as follows: CRP decreased in healthy, metabolic disorders, inflammatory bowel disease (IBD), arthritis and critically ill condition but not in renal failure. IL-1B: no change in healthy subjects and arthritis. TNF-α: decreased in healthy, fatty liver, IBD and hepatic cirrhosis, no change in diabetes, metabolic syndrome (MS) + PCOS (polycystic ovary syndrome) and arthritis. IL-6: no change in healthy, metabolic disorders and arthritis, increased in cirrhosis and renal failure, decreased in PCOS + MS. IL-10: no change in healthy, IBD and metabolic disorders, increased in arthritis. IL-4, IL-8, IL-12, IFN-g and TGF-b: no change in healthy subjects. In conclusion, probiotic/synbiotic decreased some of the inflammatory markers. The intervention was most effective in CRP and TNF-α reduction in healthy or disease state. Moreover, the intervention decreased inflammation most effectively in the following disease conditions, respectively: IBD, arthritis, fatty liver. PROSPERO REGISTRATION NUMBER: CRD42018088688.

Sesame oil and vitamin E co-administration may improve cardiometabolic risk factors in patients with metabolic syndrome: a randomized clinical trial.

OBJECTIVES: Metabolic syndrome (MetS) represents a clustering of metabolic abnormalities that are associated with an increased risk of type 2 diabetes and cardiovascular disease. We aimed to evaluate the effects of sesame oil enriched with vitamin E (vit E), sesame oil alone and sunflower oil on lipid profile, fasting blood glucose (FBG), malondialdehyde (MDA), high-sensitivity C-reactive protein (Hs-CRP), homeostatic model assessment (HOMA-IR), and blood pressure (BP) in patients with MetS. SUBJECTS: Overall, 75 individuals with MetS (aged 30-70 years) participated in this randomized, single-blind controlled trial. Patients were randomly allocated to: (1) Group A (n = 25): sesame oil (30 ml/day) enriched with vit E (400 mg/day), (2) Group B (n = 25): sesame oil (30 ml/day), (3) Group C (n = 25): sunflower oil (30 ml/day). Anthropometric data, dietary intake, blood pressure, and biochemical markers, including fasting serum lipids, FBG, serum insulin, MDA, and hs-CRP were measured at baseline and at week 8. RESULTS: In individuals in the sesame oil enriched with vit E group (Group A), there were significant reductions in serum total cholesterol (TC), triglycerides (TG), FBG, HOMA-IR, MDA, hs-CRP, high-density lipoprotein (HDL-C) systolic and diastolic BP (for all the comparison p < 0.02). Similarly, in Group B (taking sesame oil alone), TC, TG, FBG, HOMA-IR, MDA, systolic and diastolic BP were significantly improved (for all the comparison p < 0.025), while there were no significant changes in serum HDL (baseline = 35.9 ± 7.2 mg/dL vs. 36.4 ± 6.2 mg/dL, p = 0.432) and hs-CRP (baseline = 4.38 ± 1.34 mg/dL vs. week 8 = 3.96 ± 1.7 mg/dL, p = 0.057) in second group. No significant changes in any of the studied clinical and anthropometric data were found in Group C (on sunflower oil). CONCLUSION: Sesame oil (±vit E) was shown to beneficially affect several cardiometabolic indices (including lipids, FBG, BP, HOMA-IR, and MDA) in patients with MetS.

The efficacy of probiotic supplementation in rheumatoid arthritis: a meta-analysis of randomized, controlled trials.

Probiotics are considered as -immunomodulatory agents; their efficacy as an adjunct therapy option for rheumatoid arthritis (RA), however, remains controversial. The main aim of the present meta-analysis, therefore, was to compare available data from the published randomized, controlled trials (RCTs) recruiting adults with RA which compared probiotics with placebo. The English literature search was performed using Ovid version of Medline, EmBase, Web of Science, and the Central Cochrane library through October 2016 and supplemented by hand searching reference lists. Among 240 citations identified, 4 RCTs (153 participants; 89% female) were included. All data were pooled using a standardized mean difference (SMD) with a 95% CI. Compared to the placebo, probiotics did not change the inflammatory parameters (erythrocyte sedimentation rate, tumor necrosis factor [TNF]-α, interleukin [IL]-1ß, IL-6, IL-10, and IL-12) and oxidative stress indices (total antioxidant capacity and malondialdehyde) significantly. The borderline significant reduction as a result of probiotic administration was only determined in C-reactive protein [SDM - 0.32 (95% CI - 0.65 to 0.00)]. Among disease activity indices (disease activity score [DAS], tender joint count, and swollen joint count), DAS showed a significant improvement following probiotic treatment with a SMD (95% CI) of - 0.58 (- 0.97 to - 0.19). The number of trials was too small to determine if a strain-, dose-, or duration-response effect was present. Probiotics seem to be less effective in RA; however, to reach a firm conclusion, we need further evidence.

The effect of isolated soy protein adjunctive with flaxseed oil on markers of inflammation, oxidative stress, acute phase proteins, and wound healing of burn patients; a randomized clinical trial.

INTRODUCTION: The objective was to determine the effect of isolated soy protein (ISP) and flaxseed oil (FO) on inflammatory and oxidative stress indices, acute phase proteins, and wound healing of burn patients. METHODS: One hundred eighty-eight patients were assessed for eligibility in this randomized controlled trial. Of these, seventy-three eligible patients (total burn surface area 20-50%) were randomly assigned to 3 isocaloric groups, labeled as control (wheat flour+corn oil (CO)), ISP+FO, and ISP+CO, to receive these nutrients for 3 weeks. We used intention to treat analysis to overcome bias. Because of the large perturbation in water compartments, patients received nutrients from 4th to 25th day of admission. Serum high sensitivity C-reactive protein (hs-CRP), malondialdehyde (MDA), superoxide dismutase (SOD), ferritin, albumin, and transferrin were measured. The wound area was evaluated by stereological test. RESULTS: During the 3-week intervention, hs-CRP (-19.4±5.6, -11.7±4.7µg/ml) and ferritin (-83.8±20.5, -80.1±19.6ng/ml) levels changes significantly reduced compared to the control group (P<0.05). MDA level (-0.05±0.21µmol/l) significantly decreased in group A (P<0/05) but was not significant in groups B and control (P>0.05). Albumin level (0.59±0.14, 0.30±0.12g/dl) significantly increased in group A compared to the control group (P<0.05), but no significant relationship was found between other groups (P>0.05). Transferrin level (4.9±3.6, 2.9±5.1g/dl) significantly increased in ISP groups compared to the control (P<0.05). SOD improved in all groups with no significant difference between them (P>0.05). The stereology examination showed significant improvement in wound healing in the ISP groups on days 22 and 25 compared to the control group. CONCLUSION: Nutritional supplements with ISP may attenuate post-burn oxidative stress and inflammation, leading to improved wound healing in burn patients. Flaxseed oil may not exert a beneficial effect over the ISP.

The Effects of Probiotic Soymilk Fortified with Omega-3 on Blood Glucose, Lipid Profile, Haematological and Oxidative Stress, and Inflammatory Parameters in Streptozotocin Nicotinamide-Induced Diabetic Rats.

OBJECTIVE: The aim of the present study was to evaluate the effects of probiotic soymilk fortified with omega-3 in diabetic rats. METHODS: Soymilk (SM), fermented soymilk (FSM), and fermented soymilk fortified with omega-3 (FSM + omega-3) were prepared. Rats were randomly assigned to five groups of 13 animals per group. Diabetes was induced by a single injection of streptozotocin (STZ) 15 min after the intraperitoneal administration of nicotinamide (NA). Normal control (NC) and diabetic control (DC) rats received 1 mL/day of distilled water and three groups of diabetic rats were given 1 mL/day of SM, FSM, and FSM + omega-3 products by oral gavage for 28 days. RESULTS: Three products significantly (P < 0.05) reduced blood glucose, total cholesterol (TC), triglyceride (TG), and malondialdehyde (MDA) concentrations compared to the DC group, with the maximum reduction seen in the FSM + omega-3 group. Body weight, red blood cells (RBC), haemoglobin (Hb), haematocrit, and superoxide dismutase (SOD) also significantly increased in the FSM + omega-3 group. In the FSM + omega-3 group, MDA level compared with the SM and FSM groups and high sensitivity C-reactive protein (hs-CRP) concentrations compared with the DC and FSM groups were significantly lower (P < 0.05). CONCLUSION: Fermented soymilk fortified with omega-3 may be beneficial in diabetes.

A review of the benefits of Satureja species on metabolic syndrome and their possible mechanisms of action.

Metabolic syndrome, also known as insulin resistance disorder, is the simultaneous manifestation of multiple metabolic disorders in an individual. The present-day complementary and alternative therapies suggest several medicinal herbs that may have the potential to improve one or multiple complications of metabolic syndrome. All of them have their own limitations in efficacy and unwanted effects. Therefore, we reviewed species of Satureja as widespread medicinal herbs and potentially good remedies for metabolic syndrome. We reviewed literature found in PubMed and the ISI Web of Knowledge with the key word Satureja in the title. The influence of any species of Satureja on any disease or syndrome, enzymatic, metabolic, or physiological pathways, in human, animals, or in vitro conditions related to any characteristics of metabolic syndrome were considered. The main outcomes of treatment with Satureja species were categorized, and the possible mechanisms of action are discussed in this article.