A crossover randomized controlled trial examining the effects of black seed (Nigella sativa) supplementation on IL-1ß, IL-6 and leptin, and insulin parameters in overweight and obese women.

BACKGROUND: Nigella sativa (NS) oil has been found to have advantageous benefits in the management of inflammation and obesity. This study investigated the effect of NS supplementation on blood mRNA expressions and serum levels of IL-1ß, IL-6, leptin, and insulin concentrations in overweight/obese women. METHODS: In a crossover design, participants were randomized to receive either NS supplements(2000 mg/day) or placebo for 2 durations(8 weeks). With between-subject and within-subject components and interactions, a repeated-measure ANOVA model was used considering the treatment, time, and the carryover effects. Cohen's d(d) was used to measure the magnitude of the effects. RESULTS: Forty-six eligible participants were included. NS supplementation significantly reduced the mRNA expressions(d=-0.68, P = 0.03) and serum levels of IL-1ß with medium-high effect sizes(d=-1.6, P < 0.001). Significant reductions with large effect sizes were observed in the gene expression and serum levels of IL-6(d=-1.8, d=-0.78, respectively; P < 0.01) and Leptin(d=-1.9, d=-0.89, respectively; P < 0.01, serum leptin P carryover < 0.001). Despite the meaningful carryover effect for serum leptin, results remained significant following the first intervention period analysis(P < 0.001). A significant but low effect size decrease in serum insulin was observed(d=-0.3, P = 0.02). CONCLUSIONS: The clinical significance of present findings regarding improvements in obesity-related pro-inflammatory markers must be interpreted with caution due to some observed medium-low effect sizes. TRIAL REGISTRATION: IRCT20180430039475N1 (Date:25/6/2018).

The effect of synbiotic supplementation on atherogenic indices, hs-CRP, and malondialdehyde, as major CVD-related parameters, in women with gestational diabetes mellitus: a secondary data-analysis of a randomized double-blind, placebo-controlled study.

BACKGROUND: Women with GDM have a higher risk of future cardiovascular diseases (CVD). Meanwhile, synbiotics have been demonstrated to have favorable impacts on atherogenic indices, and inflammatory and oxidative stress indicators, all of which are known to be CVD-predictive factors. The aim of this randomized controlled trial was to evaluate the effects of synbiotic supplementation on the atherogenic indices of plasma, high-sensitivity C-reactive protein (hs-CRP), and plasma malondialdehyde (MDA) in women with GDM. METHODS: Eligible pregnant women with GDM were randomized into two groups to receive a daily synbiotic capsule [500 mg of L.acidophilus(5 × 1010 CFU/g), L.plantarum(1.5 × 1010 CFU/g), L.fermentum(7 × 109 CFU/g), L.Gasseri(2 × 1010 CFU/g) and 38.5 mg of fructo-oligo-saccharides], or placebo, for 6 weeks. The ratios of TC/HDL-C, LDL/HDL-C, and logTG/HDL-C were calculated as the atherogenic indices. Serum hs-CRP and MDA concentrations were quantified before and after the intervention. Cohen's d(d) was used to calculate the magnitude of the effect. RESULTS: Ninety participants completed the study. There was no significant difference in dietary antioxidant and mineral intakes between the two groups. Compared with placebo, synbiotic supplementation resulted in a significant decrease in logTG/HDL-C ratio with a medium-low effect size (mean difference = -0.11; 95% CI -0.21, 0; P values for the placebo and the intervention groups were 0.02, and 0.042, respectively; P between groups = 0.003; d = 0.25). No significant changes were observed in other parameters. CONCLUSIONS: Overall, 6 weeks of synbiotic supplementation in women with GDM resulted in a significant improvement in logTG/HDL-C, suggesting that synbiotics may have a beneficial role in reducing the risk of future CVDs associated with GDM. Nevertheless, more studies are needed to confirm the veracity of these results. Trial Registration IRCT201511183140N16 (December 29th, 2015).

The Effect of Vitamin D Supplementation on Treatment-Induced Pain in Cancer Patients: A Systematic Review.

OBJECTIVES: Despite the widespread use of complementary and alternative medicine by patients and physicians alike, there is no accurate evidence regarding the effects of vitamin D supplementation on treatment-induced pain in cancer patients. Thus, the aim of this systematic review of randomized controlled trials (RCTs) was to evaluate the impact of vitamin D administration on therapy-related pain in subjects diagnosed with malignant disorders. REVIEW ANALYSIS METHODS: We searched the Web of Science, Scopus, PubMed/Medline, Embase, and Google Scholar databases up to October 2020 to identify published RCTs that investigated the use of vitamin D in the management of treatment-induced pain in individuals with cancer. RESULTS: Nine RCTs were detected. The median duration of the intervention was of 24 weeks (range 12-52 weeks) and dose of vitamin D employed was 2000-50000 IU of vitamin D3 weekly orally each day. Six RCTs reported a significant reduction in pain, whereas three did not detect a notable decrease of this variable. Of the six studies that reported an alleviation of pain, an RCT which recruited 60 participants and lasted for 24 weeks consisted of supplementation with high doses of vitamin D2 weekly for 8 weeks in women receiving anastrozole as adjuvant therapy, then supplementation with vitamin D2 monthly for 4 months, effectively alleviated the aromatase inhibitor-associated musculoskeletal syndrome (AIMSS). The results of the same RCT also suggested a beneficial effect of vitamin D on musculoskeletal pain. CONCLUSIONS: Our results suggest that the supplementation with high doses of vitamin D in cancer patients with low serum levels of vitamin D, can be effective in reducing treatment-related pain.

The effect of omega-3 fatty acid supplementation on seizure frequency in individuals with epilepsy: a systematic review and meta-analysis.

BACKGROUND: Although there is ample evidence for the effect of omega-3 supplementation on seizure frequency in individuals with epilepsy, the results are inconsistent. Therefore, we conducted this systematic review and meta-analysis to elucidate the potential effect of omega-3 supplementation in the adult and pediatric population. METHODS: Clinical trials articles were searched in electronic databases (Web of Science, Scopus, PubMed/Medline, Embase, and Google Scholar database up to October 2020). No language limitation was imposed in the literature search. Moreover, gray literature search was done via searching the references of identified review papers to find more potentially relevant articles. RESULTS: In order, the duration of the intervention and dosage of omega-3 fatty acid supplement of the included studies ranged from 12 to 42 weeks and 1000-2880 mg/day. Pooled results from the random-effects model indicated that seizure frequency following supplementation of omega-3 fatty acid decreased significantly (WMD: -6.15, 95% CI: -7.78, -4.53, P < 0.001). Furthermore, the results of the subgroup analysis revealed that seizure frequency was more alleviated in studies that used a daily dose of 1500 mg or less of omega-3 fatty acids as well as studies that had an intervention duration of more than 16 weeks. More importantly, our findings also showed that the effect of omega-3 intervention was greater in adults than in children with epilepsy. CONCLUSION: The current meta-analysis on available trials suggested that omega-3 supplementation resulted in beneficial effects on seizure frequency in adult and children with epilepsy.

The effect of synbiotic on glycemic profile and sex hormones in overweight and obese breast cancer survivors following a weight-loss diet: A randomized, triple-blind, controlled trial.

BACKGROUND: The investigation was designed to assess the effects of synbiotic supplementation on glycemic profile, insulin-like growth factor-1 (IGF-1) and sex hormones in overweight and obese postmenopausal breast cancer survivors (BCSs) who had hormone-receptor-positive breast cancer. METHODS: This randomized, triple-blind, placebo-controlled trial was conducted on 76 overweight and obese BCSs aged 57.43 (5.82) years. All participants were given a specified low calorie diet and were randomly assigned into two groups to intake 109 CFU/day of synbiotic supplement (n = 38) or placebo (n = 38) for 8 weeks. Body composition, physical activity, glycemic profile, IGF-1, estradiol, testosterone and dehydroepiandrosterone sulfate (DHEA-S) were measured at baseline and after 8 weeks. RESULTS: A significant reduction in serum insulin (median change (Q1, Q3) from baseline of -1.05 (-2.36, 0.32) µIU/mL; P = 0.006) and insulin resistance (HOMA-IR) (mean change (SD) from baseline of -4.0 (0.9); P = 0.007) were seen over the 8 weeks in the synbiotic group. However, no significant changes were observed in serum insulin, fasting plasma glucose, HbA1c, HOMA-IR, IGF-1, estradiol, testosterone, DHEA-S and sex hormone binding globulin between-groups at the end of the intervention. CONCLUSIONS: Overall, as the 8-week synbiotic consumption compared with placebo had insignificant-reducing effects on glycemic profile, IGF-1 and sex hormones among overweight and obese postmenopausal BCSs, synbiotics may exert considerable beneficial consequences, which need to be further assessed in future clinical trials. TRIAL REGISTRATION: IRCT, IRCT2015090223861N1. Registered 02 February 2017, http://www.irct.ir: IRCT2015090223861N1.

The effect of Nigella sativa supplementation on cardiovascular risk factors in obese and overweight women: a crossover, double-blind, placebo-controlled randomized clinical trial.

PURPOSE: To assess the effect of Nigella sativa (N.S) oil supplements on CVD risk factors in a crossover design for the first time. METHODS: Obese and overweight healthy women were randomized to receive N.S oil (2000 mg/day) and placebo. This intervention period lasted for 8 weeks and separated by a 4-week washout period. An iso-caloric diet was given to every individual throughout the study. Blood pressure, lipid profile, atherogenic indices and liver enzymes were measured. Pkcross procedure was performed for statistical analyses using Stata software. Cohen's d was estimated as effect size for all outcomes to measure the magnitude of the effects. RESULTS: Thirty-nine participants completed the study. Capsules of N.S increased serum high-density lipoprotein cholesterol (Cohen's d = 0.47, P = 0.009), reduced low-density lipoprotein cholesterol (Cohen's d = - 0.33, P = 0.031), reduced TC/HDL-C ratio (as an atherogenic index, Cohen's d = - 0.9, P < 0.001), reduced serum glutamic-oxaloacetic transaminase (Cohen's d = 0- 0.5, P = 0.038) and reduced systolic blood pressure (Cohen's d = - 0.4, P < 0.001). There was no effect on diastolic blood pressure measures (P = 0.96). CONCLUSION: The overall improvements in cardiovascular disease (CVD) risk factors showed beneficial effects of N.S supplements among adults with obesity to prevent possible cardiovascular diseases. More studies with different designs and in other populations are suggested to clarify the exact effects of N.S as a complementary therapy for modulating CVD risk factors in individuals with overweight and obesity. TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT20180528039884N1, Registered on February 15th, 2019.

The effect of Nigella sativa on appetite, anthropometric and body composition indices among overweight and obese women: A crossover, double-blind, placebo-controlled, randomized clinical trial.

OBJECTIVES: Obesity is a global concern which is associated with several complications and disease. DESIGN: Present study is the first crossover, double-blind, placebo-controlled, randomized clinical trial aimed to evaluate the effect of Nigella Sativa (N. sativa) intervention on anthropometric and body composition parameters as well as dietary intake and appetite in a crossover design. METHOD: Forty-five healthy women with obesity or overweight were randomized into two groups of intervention and placebo, and the study conducted in two 8-week periods of intervention separated by a 4-week washout period. Anthropometric and body composition indices and dietary intake were measured. Also, appetite sensation was evaluated via a standard visual analog scale (VAS) questionnaire. Pkcross procedure was performed for statistical analysis using STATA. Cohen's d effect size was estimated for all outcomes to determine the magnitude of the effects. RESULTS: Supplementation with 2000 mg of N. sativa oil found to have a considerable increment in the measures of body mass index (P < 0.001, Cohen's d = 0.5), body weight (P < 0.001, Cohen's d = 0.6) and waist circumference (P = 0.020, Cohen's d = 0.4) with a medium effect size measure, and a significant decrease in body fat mass (P = 0.019, Cohen's d = 0.2), body fat percent (P < 0.001, Cohen's d = 0.2) and visceral fat area (P = 0.011, Cohen's d = 0.2) with a small effect size measure. CONCLUSION: The overall improvements in anthropometric and body composition parameters and a significant decrease in appetite represents the beneficial effects of N. sativa supplements in the treatment of obesity. More studies with different dosages, a larger number of participants, and longer intervention duration are recommended to illustrate the exact effects of N. sativa as a complementary therapy for obesity.

Effects of Vitamin D Supplementation on Omentin-1 and Spexin Levels, Inflammatory Parameters, Lipid Profile, and Anthropometric Indices in Obese and Overweight Adults with Vitamin D Deficiency under Low-Calorie Diet: A Randomized Placebo Controlled Trial.

BACKGROUND AND AIMS: Improved vitamin D levels can have a favorable effect on some metabolic variables. The objective of the current study was to determine the effects of vitamin D supplementation during a weight-loss intervention on the levels of omentin-1, spexin, lipid profiles, and inflammatory factors in obese and overweight participants. METHODS AND MATERIALS: In this double-blind placebo-controlled randomized clinical trial, 70 overweight and obese participants with vitamin D deficiency (25(OH)D ≤ 20 nmol/L) were assigned into the intervention (a daily dose of 2,000 IU vitamin D + low-calorie diet) and placebo (placebo + low-calorie diet) groups for 8 weeks. Anthropometric parameters, serum levels of 25-hydroxy vitamin D (25(OH)D), lipid profiles, omentin-1 and spexin levels, high-sensitivity C-reactive protein (hs-CRP), and soluble intercellular adhesion molecule-1 (sICAM-1) concentrations were assessed before and after the intervention. RESULTS: Vitamin D supplementation after the intervention led to a significant decrease in triglycerides (TG) (P = 0.02), very-low-density lipoprotein-cholesterol (VLDL-C) (P = 0.02), and hs-CRP (P = 0.03) concentrations and a significant increase in the serum vitamin D level (P < 0.001). Furthermore, after adjusting for baseline values, age, and baseline BMI, the levels of serum high-density lipoprotein-cholesterol (HDL-C) (P = 0.01) increased significantly, and a significant reduction was observed in the concentration of sICAM-1 (P = 0.01) in the intervention group. However, we did not find any significant difference in serum omentin-1 and spexin concentrations between the groups after intervention. CONCLUSIONS: Vitamin D supplementation along with a low-calorie diet (LCD) program for 8 weeks significantly decreased the inflammatory markers in obese individuals, while it did not alter serum omentin-1 and spexin concentrations.

The effect of Nigella sativa on the measures of liver and kidney parameters: A systematic review and meta-analysis of randomized-controlled trials.

The aim of this systematic review and dose-response meta-analysis was to determine the effect of Nigella sativa (N.S) supplementation on liver and kidney parameters. We searched PubMed, Scopus, ISI Web of Science, Cochrane central register for controlled trials and Google Scholar from database inception to April 2019 for relevant controlled trials. Mean differences and standard deviations for each outcome were pooled using a random-effects model and a dose-response analysis was performed using a fractional polynomial model. Quality of evidence was evaluated using Cochrane Collaboration Risk of Bias tool and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. Nineteen trials (n = 1295 participants) were included in the meta-analysis. We observed that N.S supplements had significant reducing effects on alkaline-phosphatase (ALP) [9 trials, n = 710 participants, weighted mean difference (WMD)= -10.825; 95 %CI: -19.658, -1.992 U/L; P = 0.016; I2 = 75.7 %; P-heterogeneity = 0.000) and blood urea nitrogen (BUN) (12 trials, n = 821 participants, WMD= -1.016; 95 % CI: -1.760, -0.273 U/L; P = 0.007; I2 = 87.7 %; P-heterogeneity = 0.000) concentrations. Subgroup analysis showed that, an intervention of more than 12 weeks was found to have a reducing effect on aspartate- aminotransferase (AST) measures (2 trials, n = 201 participants, WMD= -11.317; 95 % CI: -15.007, -7.626; P = 0.000; I2 = 0.0 %; P-heterogeneity = 0.977). Creatinine levels increased significantly in studies that considered adjusted analysis based on covariates (3 trials, n = 152 participants, WMD = 0.070; 95 % CI: 0.027, 0.112 U/L; P = 0.001; I2 = 0.0 %; P-heterogeneity = 0.788). A daily dose of 1100-1500 mg of N.S supplements was observed to have a substantial reducing effect on ALP levels (5 trials, n = 340 participants, WMD= -11.323; 95 % CI: -21.418, -1.229 U/L; P = 0.028; I2 = 0.00 %; P-heterogeneity = 0.686), while a dosage of more than 2000 mg per day led to a significant increase in BUN concentrations (2 trials, n = 101 participants, WMD= -1.016; 95 % CI: -1.760, -0.273 U/L; P = 0.007; I2 = 87.7 %; P-heterogeneity = 0.000). Our data suggested that N.S supplementation had significant impacts on liver and kidney parameters leading to a decrease in ALP and BUN levels. Longer duration of intervention and normal daily dosages of N.S supplements led to significant reductions in ALP and AST concentrations, respectively, while higher daily dosages increased BUN levels. Hence, in spite of favorable impacts of N.S supplements on liver and kidney parameters, due to the herbal nature of N.S, more studies with high-quality, large-scale, long-term intervention and precise baseline characteristics are needed to assess the exact effective dose, duration and efficacy of N.S supplementation on kidney and liver parameters.

The effect of intramuscular megadose of vitamin D injections on E-selectin, CRP and biochemical parameters in vitamin D-deficient patients with type-2 diabetes mellitus: A randomized controlled trial.

BACKGROUND AND AIMS: Inflammatory processes has been shown to be associated with the development of type 2 diabetes mellitus (T2DM) in which vitamin D supplementation might exert beneficial outcomes. We examined the effects of vitamin D supplement on inflammatory and cell adhesion molecule in patients with T2DM. METHODS: This study consisted of 50 patients with T2DM who had vitamin D deficiency. Participants were randomized into two groups of 25 in which the intervention group received two intramuscular injections of a 200000-IU vitamin D supplement, one at week 0 and another at week 4. The concentrations of fasting blood glucose (FBG), lipid profiles, liver enzymes, E-selectin, C-reactive protein (CRP), calcium, phosphorus, serum 25-hydroxyvitamin D [25(OH)D] and anthropometric indices were obtained before and after 8 weeks. RESULTS: Vitamin D resulted in significant reductions in CRP(P = 0.01) and gamma glutamyl transferase (GGT) levels(P = 0.03) and significant increases in 25(OH)D concentrations(P = 0.01) in the intervention group compared with the control. Within-group comparisons showed that FBG decreased significantly in the intervention group(P = 0.04). No significant changes were observed regarding within- and between-group comparisons of the other markers. CONCLUSION: Vitamin D had beneficial effects on the levels of CRP, serum 25(OH)D and GGT among vitamin D deficient patients with T2DM. (http://www.irct.ir: IRCT2017100336539N1).

Effects of oral Nigella sativa oil on the expression levels and serum concentrations of adiponectin, PPAR-γ, and TNF-α in overweight and obese women: a study protocol for a crossover-designed, double-blind, placebo-controlled randomized clinical trial.

BACKGROUND: Obesity is a major public health problem in recent decades. The accumulation of excessive fat promotes inflammatory status. Meanwhile, herbal products are marketed for their weight-loss properties, such as Nigella sativa (N. Sativa) which has been used for centuries to treat rheumatoid arthritis, diabetes, and asthma; recently, the anti-obesity characteristics of N. sativa have also been indicated. However, the exact mechanisms and cellular-related pathways are still unclear. Thus, we will aim to assess the effects of oral N. sativa on the gene expression of inflammatory and adipogenesis-related factors, including TNF-α, PPAR-γ, and adiponectin as well as assessing their serum concentrations among obese and overweight individuals. METHODS: Obese and overweight women aged 25-55 years with a body mass index (BMI) of 25-35 kg/m2 will be recruited from the Obesity Clinic in Shahid Sadoughi University of Medical Sciences and will be assessed for eligibility against inclusion criteria. They will be randomly assigned into two groups to receive either two capsules of N. sativa or two capsules of placebo per day for eight weeks (each capsule contains 1000 mg of N. sativa or placebo). There will be a four-week wash-out period and then participants will receive the reverse supplements for another eight weeks. Biochemical assessments and gene expressions (using real-time polymerase chain reaction) will be conducted at the beginning and at the end of every intervention period. DISCUSSION: The present study will investigate the probable cellular pathways for the anti-obesity effects of N. sativa in overweight/obese women. TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT20180528039884N1 . Registered on 2nd of July, 2018.

The Effect of Dietary Intervention Along with Nutritional Education on Reducing the Gastrointestinal Side Effects Caused by Chemotherapy Among Women with Breast Cancer.

Gastrointestinal (GI) side effects caused by chemotherapy in women with breast cancer are common but poorly understood which might be controlled by nutritional intervention. Thus, the major aim of this study was to assess the effect of dietary intervention along with nutritional education on reducing these side effects. The present study is a single-center, single-controlled, and randomized trial. A total of 150 patients with breast cancer undergoing chemotherapy were randomly assigned into intervention group to receive dietary intervention and nutritional education (n = 73) or control group (n = 67) for 10 weeks, after their three sessions of chemotherapy. The primary endpoint was the GI symptoms after each session of chemotherapy that were measured by a designed questionnaire based on ROMIII questionnaire. The severity of GI side effects in the dietary intervention along with nutritional education was decreased significantly in the third session of chemotherapy compared to the first session, which include reflux disorder (P = 0.05), anorexia (P < 0.001), nausea (P = 0.002), constipation (P < 0.001), and diarrhea (P < 0.001). Moreover, significant reductions were observed in the severity of GI side effects in the intervention group compared to control group after the third session (P < 0.001). After adjusting the analysis for baseline values including age, job, education level, weight, and body mass index, significant changes were observed for GI side effects in the intervention group compared to the control group (P < 0.001). This study showed beneficial effects of individualized dietary intervention along with nutritional education on reducing diarrhea, constipation, vomiting, and nausea in women with breast cancer during the chemotherapy.

The effect of probiotic supplementation on glycemic control and lipid profile in patients with type 2 diabetes: A randomized placebo controlled trial.

AIMS: The role of gut microbiota in the pathogenesis of diabetes is increasing; this study investigates the effect of multi-strain probiotics on fasting plasma glucose (FPG), plasma insulin and lipid profile among patients. METHODS: This randomized double blind controlled trial was performed among 60 patients; individuals were randomly assigned into 2 groups of 30 participants in order to take either probiotic supplements or placebo for 6 weeks. The probiotic supplement consisted of 7 viable strains Lactobacillus, Bifidobacterium and Streptococcus. Nutrient intakes were estimated using a 3-day and 24 hour-dietary recall at the beginning and end of study. Fasting blood samples were taken before and after intervention to measure the levels of FPG, plasma insulin and lipid profiles. RESULTS: Within group comparisons showed significant decrease and increase in the levels of FPG (P = 0.001) and HDL-C (P = 0.002) in probiotic group, respectively. No significant alterations were observed for within and between group comparisons in the levels of insulin, triglycerides, total cholesterol, insulin resistance and anthropometric measurements, including weight, waist circumference and body mass index (all P > 0.05). CONCLUSIONS: This study showed a significant decrease in FPG level by multi-strain probiotic supplements in within group comparison; though, further studies are needed to confirm results. (IRCT Code: IRCT2013100714925N1).

Effects of symbiotic and vitamin E supplementation on blood pressure, nitric oxide and inflammatory factors in non-alcoholic fatty liver disease.

Non-alcoholic fatty liver disease (NAFLD) has been suggested to be well correlated with altered blood pressure. This study was conducted to determine the effects of symbiotic and vitamin E supplementation on blood pressure and inflammatory indices of patients with NAFLD. This randomized, double-blind, placebo-controlled trial was performed among 60 NAFLD patients aged 25 to 64 years old. Participants were randomly divided into four groups to receive a 400 IU alpha-tocopherol and 2 × 108 CFU/g symbiotic supplement for 8 weeks. The anthropometric parameters, systolic blood pressure (SBP) and diastolic blood pressure (DBP), serum malondialdehyde (MDA), nitric oxide (NO) and tumor necrosis factor α (TNFα) were assessed at baseline and after 8 weeks of intervention. After 8 weeks of intervention, combined symbiotic and alpha-tocopherol, symbiotic and alpha-tocopherol alone administration, compared with the placebo, resulted in significant decreases in SBP (-17.07±2.1, -16.07±3.56, -1.73±2.25 and -1.55±3.01 mmHg, P=0.01), serum MDA (-1.19±0.5, -0.12±0.65, 0.14 ± 0.64 and 0.16±0.34 nmol/mL, P<0.001), serum TNFα (-15.62±13.93, -9.24±7.12, -11.44 ± 15.47 and 3.01±1.71 pg/ml, P<0.001) concentrations. A significant decrease in serum AST (-11.36±4.52, -7.43±8.58, -5.93±6.61 and 2.5±5.75 µmol/L, P <0.001), ALT (-12.79±3.65, -3.66±6.81, -6.54±7.66 and 4.16±3.43 µmol/L, P <0.001) and ALP (-26.8±11.1, -4.56±9.22, -14.48±12.22 and 5.19±2.64 µmol/L, P <0.001) was seen. Variations in DBP and serum NO concentration were not significant. Alpha-tocopherol and symbiotic supplementation among patients with NAFLD resulted in decreased SBP, serum MDA, TNFα levels and enzymes liver; however, they did not affect DBP and serum NO concentration.