The effects of grape seed extract supplementation on cardiovascular risk factors, liver enzymes and hepatic steatosis in patients with non-alcoholic fatty liver disease: a randomised, double-blind, placebo-controlled study.

BACKGROUND: Despite the high antioxidant potential of grape seed extract (GSE), very limited studies have investigated its effect on non-alcoholic fatty liver disease (NAFLD). Therefore, this study was conducted with the aim of investigating the effect of GSE on metabolic factors, blood pressure and steatosis severity in patients with NAFLD. METHODS: In this double-blind randomized clinical trial study, 50 NAFLD patients were divided into two groups of 25 participants who were treated with 520 mg/day of GSE or the placebo group for 2 months. The parameters of glycemic, lipid profile, blood pressure and steatohepatitis were measured before and after the intervention. RESULTS: The GSE group had an average age of 43.52 ± 8.12 years with 15 women and 10 men, while the placebo group had an average age of 44.88 ± 10.14 years with 11 women and 14 men. After 2 months of intervention with GSE, it was observed that insulin, HOMA-IR, TC, TG, LDL-c, ALT, AST, AST/ALT, SBP, DBP and MAP decreased and QUICKi and HDL-c increased significantly (p-value for all < 0.05). Also, before and after adjustment based on baseline, the average changes indicated that the levels of insulin, HOMA-IR, TC, TG, LDL-c, SBP, DBP, MAP in the GSE group decreased more than in the control group (p for all < 0.05). Furthermore, the changes in HDL-c were significantly higher in the GSE group (p < 0.05). The between-groups analysis showed a significant decrease in the HOMA-ß and AST before and after adjustment based on baseline levels (p < 0.05). Moreover, the changes in QUICKi after adjustment based on baseline levels were higher in the GSE group than in the control group. Also, between-groups analysis showed that the severity of hepatic steatosis was reduced in the intervention group compared to the placebo group (P = 0.002). CONCLUSIONS: It seems that GSE can be considered one of the appropriate strategies for controlling insulin resistance, hyperlipidemia, hypertension and hepatic steatosis in NAFLD patients. TRIAL REGISTRATION: The clinical trial was registered in the Iranian Clinical Trial Registration Center (IRCT20190731044392N1). https://irct.behdasht.gov.ir/trial/61413 . (The registration date: 30/03/2022).

Grape seed extract supplementation in non-alcoholic fatty liver disease.

Background: Despite rising non-alcoholic fatty liver disease (NAFLD) prevalence and its impact on liver health, there's a lack of studies on grape seed extract's (GSE) effect on oxidative stress and quality of life (QoL) in NAFLD patients. This study aims to fill this gap by the potential benefits of GSE in reducing oxidative stress and improving QoL. Methods: In this randomized clinical trial study, fifty patients with NAFLD were randomly assigned to receive either 2 tablets of GSE containing 250 mg of proanthocyanidins or placebo (25 participants in each group) for two months. QoL was evaluated using the SF-36 questionnaire, and oxidative stress variables (TAC, MDA, SOD, GPx, CAT, and IL-6) were measured at the beginning and end of the study. Results: Compared with the control group, the group supplemented with GSE experienced greater reductions in IL-6 and MDA (3.14±1.43 pg/ml vs. 2.80±0.31 pg/ml; 4.16±2.09 µM vs. 4.59±1.19 µM, p for all <0.05), as well as greater increases in TAC, SOD, and GPx levels (0.18±0.08 mM vs. -0.03±0.09 mM; 10.5±6.69 U/ml vs. 8.93±1.63 U/ml; 14.7±13.4 U/ml vs. 8.24±3.03 U/ml, p for all <0.05). Furthermore, the QoL questionnaire showed that physical limitations, general health, and total physical health were significantly improved in the GSE group compared with the placebo (17.0±42.0 vs. -12.0±37.5; 3.80±14.8 vs. -3.92±9.55; 5.08 5.26 vs. -7.01±13.7, p for all <0.05). Conclusions: GSE can be effective in improving oxidative stress and QoL in patients with NAFLD. More studies are needed to confirm the results of this study.

The association between the dietary inflammatory index and gestational diabetes mellitus: A systematic review of observational studies.

BACKGROUND & AIMS: Unhealthy dietary habits contribute to low-grade chronic inflammation that is known to be associated with metabolic disorders and pregnancy complications such as gestational diabetes mellitus (GDM). The dietary inflammatory index (DII) is a scoring system for assessing the inflammatory potential of various nutrients and foods. This systematic review aims to investigate the current state of evidence on the association between DII and GDM in pregnant women. METHODS: PubMed, Scopus and Web of Science electronic databases were systematically searched for relevant English-language articles published up to February 2023. This study was developed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (CRD42022382813). RESULTS: This review included seven studies (98,115 participants) from five countries. In total, two case-control studies have shown a positive association between DII and GDM. In contrast, three of five cohort studies found no association between dietary inflammatory potential and the risk of developing GDM. CONCLUSION: We found some controversial results due to the small number of studies, with major heterogeneity in research design and findings. Collectively, the current study does not support an association between the DII score and the risk of gestational diabetes. Further, longitudinal studies are needed to elucidate the association between dietary inflammatory potential and GDM.

Probiotics Supplementation Improves Quality of Life, Clinical Symptoms, and Inflammatory Status in Patients With Psoriasis.

BACKGROUND: Studies have proposed a link between psoriasis and imbalanced gut microbiome. Therefore, the modulation of the gut microbiota with probiotics may improve clinical outcomes, chronic inflammation, and cardiovascular risk factors in patients with psoriasis. METHODS: In a randomized double-blind placebo-controlled clinical trial, forty-six patients with psoriasis randomly assigned into probiotic capsules contains multi-strain at least 1.6× 109 CFU/g bacteria or placebo for two months. Psoriasis Area and Severity Index (PASI), blood pressure, quality of life (QOL) pro-inflammatory cytokines (hs-CRP and IL1-β), and lipopolysaccharides (LPS) were measured. RESULTS: Improvements in QOL was significant in patients taking probiotics supplementation comparing to the placebo group and PASI (-5.06±2.10 vs 0.30±1.80, P=0.049) as well. After the intervention, a considerable reduction in serum LPS levels (-7.21±10.33 vs -2.74±0.97 mmol/L, P=0.010), hs-CRP levels (-1.67±0.95 vs -0.70+ 0.38 mg/L, P=0.013), and IL1- β levels (-1.64±1.10 vs 0.17+ -0.20 mg/L, P=0.043) in the probiotics group. CONCLUSION: This study shows that probiotics significantly improved the quality of life and seriousness in psoriatic patients. Moreover, it enhances cardiovascular risk factors and inflammatory/oxidative stress markers. TRIAL REGISTRATION: This trial also was recorded in the Iranian registry of clinical trials (https://www.irct.ir) (code: IRCT20191124045483N1). J Drugs Dermatol. 2022;21(6):637-644. doi:10.36849/JDD.6237.

Does nano-curcumin supplementation improve hematological indices in critically ill patients with sepsis? A randomized controlled clinical trial.

Sepsis is the final common pathway to death for severe infectious diseases worldwide. The present trial aimed to investigate the effects of nano-curcumin supplementation on hematological indices in critically ill patients with sepsis. Fourteen ICU-admitted patients were randomly allocated into either nano-curcumin or placebo group for 10 days. The blood indices, serum levels of inflammatory biomarker and presepsin as well as nutrition status, and clinical outcomes were assessed before the intervention and on days 5 and 10. White blood cells, neutrophils, platelets, erythrocyte sedimentation rate (ESR), and the levels of interleukin-8 significantly decreased in the nano-curcumin group compared to the placebo after 10 days of intervention (p = .024, p = .045, p = .017, p = .041, and p = .004, respectively). There was also a marginal meaningful decrease in serum presepsin levels in the intervention group compared to the placebo at the end of the study (p = .054). However, total lymphocyte count showed a significant increase in the nano-curcumin group compared to the placebo at the end-point (p = .04). No significant differences were found in the level of lymphocyte and the ratios of neutrophil/lymphocyte and platelet/lymphocyte between the study groups. Moreover, no significant between-group differences were observed for other study outcomes, post-intervention. Collectively, nano-curcumin may be a useful adjuvant therapy in critically ill patients with sepsis. However, further trials are suggested to examine the effects of nano-curcumin in the management of sepsis and its complications. PRACTICAL APPLICATIONS: Curcumin (1,7-bis[4-hydroxy-3-methoxyphenyl]-1,6-heptadiene-3,5- dione) or diferuloylmethane is widely used in medicine due to its several biological properties. Recent evidence has shown that curcumin possesses multiple pharmacological activities including immune-modulatory, antioxidant, anti-inflammatory, anti-cancer, and anti-microbial effects. In this study, it was observed that nano-curcumin at a dose of 160 mg for 10 days, without side effects, reduced some inflammatory factors and regulated the immune responses in sepsis patients. For the first time, this trial was conducted to determine the effect of nano-curcumin on hematological indices and the serum levels of presepsin and IL-8.

Probiotic supplementation improves clinical outcomes and quality of life indicators in patients with plaque psoriasis: A randomized double-blind clinical trial.

BACKGROUND & AIMS: The impact of probiotics on psoriasis, a systemic inflammatory disease, remains obscure, thus we decided to evaluate quality of life (QOL), oxidative stress, inflammatory markers and clinical outcome in psoriasis patients. METHODS: Fifty patients with plaque psoriasis randomized into two groups, group 1 received probiotic drink with Lactobacillus strains for 8 weeks while group 2 haven't received any probiotic supplements at this period. The Dermatology Life Quality Index (DLQI) and Beck's questionnaire (BDI) were used to investigate the quality of life and depression, respectively. The effects of supplementation on malondialdehyde (MDA), hs-CRP, IL-6, total antioxidant capacity (1) and psoriasis area and severity index (PASI), psoriasis symptom scale (PSS) were measured at the beginning of the study and after week 8th. RESULTS: Total BDI scores significantly improved in the probiotic group in comparison with the placebo group (-6.15 ± 2.10 vs. 1.39 ± 1.80, P = 0.017) and DLQI (-9.50 ± 4.1 vs. 0.12 ± 0.6, P = 0.045) as well. Group 1 had a considerable reduction in PASI and PSS scores compared to the placebo group (-5.26 ± 3.75 vs. 0.48 ± 1.37, P = 0.049) and (-4.85 ± 3.10 vs. 0.43 ± 0.80, P = 0.047), respectively. In addition, the intervention group have shown increase in TAC levels (45.99 ± 23.33 vs -13.54 ± 30.7 mmol/L, P = 0.030), and decrease in hs-CRP levels (-1.55 ± 0.85 vs. -0.49 + 0.27 mg/L, P = 0.015), IL-6 levels (-4.04 ± 1.30 vs. -1.50 + 0.38 mg/L, P = 0.050) and MDA levels (-71.08 ± 35.73 vs. -9.8 + 15.6 nmol/mL, P = 0.013) compared to the placebo group. CONCLUSIONS: Probiotics improve patients' quality of life and inflammatory biomarkers in psoriatic patients. Further studies are mandatory to propose probiotics as routinely prescribed therapy in inflammatory dermatoses. TRIAL REGISTRATION: This trial was registered at www.irct.ir as IRCT20180712040438N2.

The significance of the oxidative stress markers in the one-year prognosis of patients with acute ischemic stroke: a case-control study.

BACKGROUND: Stroke is a major cause of mortality and morbidity. Also, free radicals and oxidative stress are deleterious factor in the stroke progression. We aimed to evaluate the association between oxidative stress markers and odds of having risk factor for stroke or developing stroke. METHODS: The present case-control study was conducted on 556 participants in Imam-Reza hospital, Tabriz, Iran. Subjects were divided into three group, including individuals with acute ischemic stroke, those who were at risk of stroke, and healthy controls. All enrolled participants except for controls underwent neurological examinations and brain magnetic resonance imaging (MRI). Stroke-related disability and stroke severity were evaluated by modified Rankin Scale (mRS) and National Institutes of Health Stroke Scale (NIHSS), respectively. Serum malondialdehyde (MDA) level and total antioxidant capacity (TAC) were measured within 48 h of the initiation of stroke. One-way ANOVA and Chi-square tests were used for comparing characteristics between groups. Multivariable logistic regression was implemented for odds of stroke based on MDA and TAC quartiles. Also, Spearman's correlation was utilized. RESULTS: Serum MDA, systolic and diastolic blood pressure, cholesterol, and triglyceride were significantly higher in the stroke group than controls. High levels of MDA were associated with increased development of stroke (P-value < 0.001), however TAC and MDA were not associated with having risk factors for stroke (P-value = 1.00 and 0.27, respectively). Also, TAC level was negatively associated with baseline (ρ = - 0.28; P-value = 0.04) and follow-up (ρ = - 0.31; P-value = 0.03) NIHSS scores. Moreover, MDA was correlated with mRS score at follow-up (ρ = - 0.26; P-value = 0.04). CONCLUSIONS: The balance between antioxidants and oxidants markers might reveal a new approach in this context. Further studies are warranted to identify the source of oxidative stress as well as cessation of the production of oxygen radicals in stroke.

Relationship between the levels of serum fibroblast growth factor 19 and metabolic factors in obese and normal weight subjects with and without type 2 diabetes mellitus: a case-control study.

OBJECTIVES: Fibroblast growth factor 19 (FGF-19) is a metabolic regulating factor with an anti-diabetic effect. This study aimed to evaluate FGF-19 in patients with type 2 diabetes mellitus (T2DM) and its relationship with some metabolic risk factors. METHODS: In this case-control study, 80 diabetic patients and 80 non-diabetic individuals were divided into two subgroups based on body mass index (BMI): obese people (BMI≥30) and participants with normal weight (25>BMI≥18.5). Furthermore, stratified analysis by gender was also performed. The metabolic factors were measured and compared in all groups. The relationship between FGF-19 and the measured items was investigated in each group. RESULTS: The FGF-19 levels did not show a significant difference between groups. The serum levels of FGF-19 were negatively associated with some metabolic items, such as BMI, low-density lipoprotein (LDL), total cholesterol (TC) (p<0.01), and LDL/high-density lipoprotein (HDL) ratio (p=0.02) only in the healthy group with normal weight. According to the gender-based classification of individuals, FGF-19 showed a significant inverse relationship with BMI, weight (WT), waist circumference (WC), and hip circumference (HC) (p<0.05) in diabetic men; besides, FGF-19 in non-diabetic women had a significant negative association with TC, LDL, and LDL/HDL ratio (p<0.05). CONCLUSIONS: The levels of FGF-19 were negatively correlated to WT, BMI, WC and HC in diabetic males. More studies are needed to warrant these results.