Synthesis and evaluation of the antifungal activity of 5-hydroxy-3-phenyl-1H-pyrazole-1-carbothioamide for use in the oral environment.

Background and aim: Candida albicans and Candida tropicalis, can cause superficial infections of the oral mucosa as well as disseminated bloodstream and deep-tissue infections. The most frequently employed class of antifungals used for Candida infection treatment are the azole antifungals. Their low price, low toxic qualities, and availability for oral use make fluconazole and similar azole antifungals the preferred treatment for various infections caused by Candida. Nevertheless, developed and intrinsic resistance to antifungals of the azole family has been widely documented in association with various species of Candida. Candida infection management requires synthesizing new compounds to improve azole class antifungals, as Candida isolates resistant to azole are increasingly encountered in the clinical setting. This study aimed to synthesize a new azole compound and investigate its antifungal activity. Methods: In this experimental study, 5-hydroxy-3-phenyl-1H-pyrazole-1-carbothioamide was synthesized by the reaction between thiosemecarbazide and ethylbezoylacetate. The structure of the synthesized compound was characterized by different techniques such as Fourier transform infrared (FT-IR) and nuclear magnetic resonance (NMR) spectra and its antifungal activity against Candida albicans and Candida tropicalis was investigated by the Spread Plat method to determine its minimum fungicidal concentration (MFC) and minimum inhibitory concentration (MIC). Results and discussion: The Spread Plat test demonstrated that with the increase in 5-hydroxy-3-phenyl-1H-pyrazole-1-carbothioamide concentration, colonies of fungi were increasingly eliminated at a significant level(p < 0.001). At a concentration of 1000 ppm, all Candida albicans and Candida tropicalis colonies were destroyed. Conclusions: The results indicate that the synthesized compound showed a promising antifungal effect. On the other hand, it had a suitable spectrum of effect, because it showed antifungal effects on both Candida albicans and Candida tropicalis strains.

The association between dietary inflammatory index and C-reactive protein in plasma and semen with semen quality: A cross-sectional study.

Background: Infertility affects couples worldwide, with male factors being responsible for half of all cases. Objective: This study aimed to investigate the relationship between dietary inflammatory index (DII) and levels of C-reactive protein (CRP) in plasma and semen with the quality of semen in infertile males. Materials and Methods: In this cross-sectional study, 88 infertile men referring to Besat hospital, Tehran, Iran from December 2021-November 2022 were enrolled. A detailed questionnaire requesting information, and a 168-item semiquantitative food frequency questionnaire, were completed by participants. A food frequency questionnaire was used to calculate the DII. Additionally, semen and blood samples were collected from each participant for semen analysis and CRP-level assessment. Statistical analyses were performed to explore the association between DII and CRP levels with sperm quality. The correlation between DII and serum/semen CRP, besides assessing nutrients in each DII quartile group, was also explored. Results: A significant difference was observed between different DII quartiles considering sperm motility (p = 0.006) and morphology (p = 0.014). Post hoc study revealed a significant difference between the 1st and 2nd quartiles and the 1st and 4th quartiles of DII regarding sperm motility (p = 0.011, and 0.017 respectively) and a significant difference between the 1st and 2nd quartiles of DII considering sperm morphology (p = 0.009). A statistically significant inverse correlation was also observed between DII and sperm motility (p = 0.017). Carbohydrates and ß-carotenes were significantly different between the 4 DII quartiles (p = 0.043 and p = 0.026, respectively). Finally, no significant correlation was observed between DII and CRP levels in blood and semen (p > 0.05). Conclusion: The findings suggested a notable correlation between DII and semen quality; however, no significant association were observed between DII and CRP levels in blood and semen.

The effect of Spirulina supplementation on lipid profile: GRADE-assessed systematic review and dose-response meta-analysis of data from randomized controlled trials.

BACKGROUND: Cardiovascular diseases (CVD) are one of the most important causes of death worldwide. Dyslipidemia is one of the main causal risk factors for CVD that can be controlled by modifying lifestyle, which entails the use of healthy diets containing functional foods. The present study was conducted to summarize the effects of Spirulina on the lipid profile in previous randomized controlled trials. METHODS: MEDLINE, Scopus, Clarivate Analytics Web of Science, and the Cochrane Library databases were searched systematically until January 2023, for clinical interventions that investigated the effect of Spirulina supplementation on plasma lipid profile concentrations. RESULTS: ooled results of 20 studies (with 23 arms and 1076 participants) indicated that Spirulina intervention significantly reduced LDL-C (SMD: -0.6, 95% CI: -0.9, -0.2, P<0.05), TC (SMD: -0.6, 95% CI: -0.9, -0.2, P<0.05) and TG (SMD: -0.6, 95% CI: -0.9, -0.2, P<0.05) levels while HDL-C levels were significantly increased (SMD: 0.3, 95% CI: 0.0, 0.6, P<0.05). CONCLUSIONS: The findings of the present meta-analysis and review show the usefulness of supplementing with Spirulina in improving serum levels of TC, TG, LDL-C, and HDL-C.

Effects of Dietary Modification Based on Complementary and Alternative Iranian Medicine in Patients with Secondary-Progressive Multiple Sclerosis: A Randomized Controlled Clinical Trial.

Objectives: To evaluate the efficacy of dietary modifications based on complementary and alternative Iranian medicine (CAIM) in patients with secondary-progressive multiple sclerosis (SPMS). Design: In this randomized controlled trial, 70 SPMS patients were randomized to receive either a moderate-nature diet based on Persian medicine (as intervention) or usual diet plus health-related diet recommendations (as control) for 2 months. Serum high-sensitivity C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), Expanded Disability Status Scale (EDSS), Modified Fatigue Impact Scale (MFIS), State-Trait Anxiety Inventory (STAI), Global Pain Scale (GPS), Gastrointestinal Symptom Rating Scale (GSRS), anthropometric measurements, and quality of life (QOL) were assessed at baseline and end of trial. Analysis of covariance was performed, and the results were adjusted for potential confounders using SPSS v.14. Results: All participants completed the study for 2 months. There were significant improvements across the mean changes of hs-CRP (-0.1 ± 0.2 mg/L for intervention vs. -0.01 ± 0.13 mg/L for control; padjusted = 0.012), MFIS (-11.0 ± 11.8 vs. -0.7 ± 9.9; padjusted <0.001), GSRS (-19.9 ± 16.3 to 1.2 ± 17.5; padjusted <0.001), GPS (padjusted = 0.032), and QOL (padjusted <0.05). No significant difference was observed across the ESR, EDSS, STAI, and anthropometric measurements. Conclusion: Dietary modifications based on CAIM may improve inflammation and clinical manifestations in SPMS patients. Nonetheless, further trials are required to confirm these findings. Clinical Trial Registration: IRCT20181113041641N2.

Lifestyle assessment in individuals with spinal cord injuries caused by accidents and disasters in qualitative studies published from 1990 to 2020: A meta-synthesis of qualitative study.

Background and Aims: As a debilitating disorder, spinal cord injuries (SCIs) can bring about a range of physical, psychological, and social consequences in individuals and even have effects on their lifestyle indicators. The present study was thus to reflect on lifestyles among people with SCIs developing from accidents and disasters. Methods: Using a meta-synthesis of qualitative research, all articles recruiting qualitative methods to examine patients with SCIs, published from 1990 to 2020, were retrieved by the researchers, good at the Persian and English languages, from the databases of ScienceDirect, MD Consult, Pedro, ProQuest, PubMed, SID, MedLib, Magiran, Scopus, Google Scholar, Iranmedex, the Cochran Library, CINAHL, and Blackwell, tapping the keywords of "spinal cord injury, SCI, manmade disaster, natural disaster, content analysis, concept analysis, thematic analysis, lifestyle, quality of life, QoL, grounded theory, meta-synthesis, mixed-methods research, historical research, ethnography, and phenomenology" in both languages for their inclusion in this study and further analyses. Results: With reference to the inclusion criteria, 18 articles were extracted, and after all 10 studies in line with the research topic were reviewed and analyzed. Ultimately, six main themes, namely, compromise, self-reliance, income-generating activities, mental status, inability, and issues of sexuality were extracted, demonstrating their importance to individuals suffering from SCIs. Conclusion: During the initial stages following SCIs, the abilities to engage in participatory practices and individual's power of decision-making diminish because of physical, social, psychological, and environmental constraints. It was accordingly recommended to have a holistic perspective and respect all aspects of life in individuals with SCIs.

The Association between Dietary Inflammatory Index with Risk of Coronavirus Infection and Severity: A Case-Control Study.

Background: Recently, several have evaluated the association between the components of the dietary inflammatory index (DII) score with the risk and severity of Coronavirus Disease 2019 (COVID-19). For the first time, we examined the association between DII® with risk of coronavirus infection and symptom severity through a case-control study in Iran. Methods: The present case-control study was conducted on COVID-19 cases (n = 100) and healthy control (n = 100) volunteer, aged from 18 to 65 years. Dietary intake, DII, body mass index, COVID-19 infection, and the severity of its symptoms were assessed for each participant. A multivariable logistic regression analysis test was used to estimate the odds ratio and 95% confidence interval. Results: Our results demonstrated that COVID-19-infected patients were significantly older and had longer history of diabetes as compared to the healthy control group (P <.05). Furthermore, the participants with COVID-19 had a significantly greater intake of total fat (P =0.259), saturated fat (P =0.005), and dietary fiber (P = .004). In contrast, individuals in the healthy control group had a higher intake of carbohydrate (P = .005), sodium (P <.001), and iron (P <.001). However, there was no significant difference in DII score between COVID-19 and healthy controls (P =.259). In addition, we did not detect any specific association between DII score and risk of COVID-19 infection (odds ratio = 1.08, 95% confidence interval: 0.92 to 1.27; P =.294) and the severity of its symptoms (P >.05). Conclusions: There appears to be no specific association between DII score and risk of COVID-19 infection and the severity of its symptoms. More prospective cohort studies are necessary to confirm the veracity of our results.

The effect of l-carnitine supplementation on mortality and clinical outcomes in ventilator-dependent critically ill patients with obesity and COVID-19: Protocol for a randomized double-blind placebo-controlled trial.

Background: Coronavirus disease 2019 (COVID-19) still remains a pandemic accounting for at least 15% of intensive care unit (ICU) admissions. Recently, it has been observed that l-carnitine levels, which play an important role in fatty acid metabolism, have an inverse association with the severity of COVID-19 and its complications, hence a potential role for supplementing with this nutraceutical has been suggested. The current protocol describes a trial aiming to an evaluation of the effect of l-carnitine intervention on mortality and clinical outcomes in ICU-admitted patients with COVID-19. Methods: This parallel-group, randomized, placebo-controlled, and double-blind clinical trial involves 50 participants and will be performed at the ICU of Artesh (AJA) Hospital, Mashhad, IRAN. Eligible participants will be randomized into two groups: 1) the intervention group will receive 1000 mg l-carnitine capsules 3 times a day, and 2) the placebo group will receive 1000 mg placebo capsules 3 times a day. Assessments will be performed at baseline, 7 and 28 days after study initiation. The primary outcome includes changes in serum levels of C-reactive protein (CRP). Secondary outcomes include the length of stay in the ICU, ICU mortality, hospital mortality, 28-day mortality, duration of mechanical ventilation (MV), and the neutrophil-lymphocyte ratio (NLR). Conclusion: Based on previous evidence, l-carnitine may reduce inflammation and oxidation stress and improve respiratory function. However, the effects of l-carnitine on ventilator-dependent COVID-19 critically ill patients have not been assessed yet, justifying the necessity to conduct a clinical study in this field. c.

The Effect of L-Citrulline Supplementation on Outcomes of Critically Ill Patients under Mechanical Ventilation; a Double-Blind Randomized Controlled Trial.

Introduction: Effective parenteral and enteral amino acid replacement is crucial for critically ill patients with altered amino acid metabolism. This study aimed to assess the effects of l-citrulline supplementation on the clinical and laboratory outcomes in critically patients. Methods: This was a double-blind placebo-controlled randomized clinical trial. 82 critically ill patients who were expected to receive mechanical ventilation for more than 72 hours were selected. The patients were assigned to either a placebo or an intervention group. The patients in the placebo group received 10 gr of microcrystalline cellulose and the ones in the intervention group were given l-citrulline daily for 7 days. Serum levels of fasting blood sugar (FBS), lipid profile, hepatic enzymes, serum electrolytes, urea nitrogen, creatinine, and C-reactive protein (CRP) were evaluated before and after the intervention. Duration of invasive ventilation, intensive care unit (ICU) length of stay, ventilator-free days, and 28-day mortality rate were recorded and compared between groups. Results: Eighty-two patients completed the trial. No statistically significant differences were observed between the two groups in terms of age (p = 0.46), sex (p = 0.49), body mass index (BMI) (p = 0.41), Sequential Organ Failure Assessment (SOFA) Score (p = 0.08), Clinical Pulmonary Infection Score (CPIS) score (p = 0.76), Acute Physiology and Chronic Health Evaluation (APACHE II) score (p = 0.58), risk factors (p = 0.13), ICU stay before randomization (p = 0.32), and reason of admission (p = 0.50) before the intervention. Citrulline group had a notable reduction in FBS (p = 0.04), total cholesterol (TC) (p = 0.02), low density lipoprotein (LDL-C) (p <0.001) and high-sensitivity CRP (hs-CRP) (p <0.001). Also, a significant increase in lactate dehydrogenase (LDH) concentration (p <0.001) was observed in the intervention group at the end of the trial. Total duration of invasive ventilation and the mean SOFA score on 7th day were significantly lower in the citrulline group compared to the control group. Moreover, a significant increase in days alive and ventilator-free days within 28 days after admission was found in the citrulline group at the end of the trial. Also, there were no significant differences between the groups in terms of mortality rate during intervention, serious adverse events, endotracheal intubation, the use of tracheotomy or non-invasive ventilation after extubation, length of ICU stay, ICU-free days at 28 days, and CPIS and APACHE II scores. For mortality, in the citrulline group, there was two deaths compared to eight deaths in the control group. This resulted in an absolute risk reduction (ARR) of 14.05% (95% CI: 0.39-27.71%) and a number needed to treat (NNT) of 7.1 (95% CI: 3.6-29.5), regarding mortality. Conclusions: The results of the present study demonstrated the probable positive effects of citrulline supplementation on lipid profile, hs-CRP levels, duration of invasive ventilation, and SOFA score. Also, l-citrulline consumption may increase the probability of survival without mechanical ventilation.

An overview on role of nutrition on COVID-19 immunity: Accumulative review from available studies.

The novel coronavirus infection (COVID-19) conveys a serious global threat to health and economy. A common predisposing factor for development to serious progressive disease is presence of a low-grade inflammation, e.g., as seen in diabetes, metabolic syndrome, and heart failure. Micronutrient deficiencies may also contribute to the development of this state. Therefore, the aim of the present study is to explore the role of the nutrition to relieve progression of COVID-19. According PRISMA protocol, we conducted an online databases search including Scopus, PubMed, Google Scholar and web of science for published literatures in the era of COVID-19 Outbreak regarding to the status of nutrition and COVID-19 until December 2021. There were available studies (80 studies) providing direct evidence regarding the associations between the status of nutrition and COVID-19 infection. Adequate nutritional supply is essential for resistance against other viral infections and also for improvement of immune function and reduction of inflammation. Hence, it is suggested that nutritional intervention which secures an adequate status might protect against the novel coronavirus SARS-CoV-2 (Severe Acute Respiratory Syndrome - coronavirus-2) and mitigate its course. We also recommend initiation of adequate nutritional supplementation in high-risk areas and/or soon after the time of suspected infection with SARS-CoV-2. Subjects in high-risk groups should have high priority for applying this nutritive adjuvant therapy that should be started prior to administration of specific and supportive medical measures.

Compact food bar improves cardiopulmonary function in men military athletes: A randomized, placebo-controlled, single-blind clinical trial.

Background: This study aimed to evaluate the effects of compact food bar (CFB) designed on cardiopulmonary function in men athletes who serve in military service. Materials and Methods: In this randomized, single-blind, controlled clinical trial, 46 men of military staff were arranged into 2 groups and studied for 28 days; one branch used 3 packs daily, 700 kcal each, of CFB with Functional compounds (Caffeine and L-arginine) and the other group used regular food during training course. Maximal oxygen uptake (VO2 Max) in vitro with cardiopulmonary exercise test, body composition, and physical activity were assessed and recorded at baseline and end of the study period. Results: VO2 Max (P = 0.05) significantly increased in CFB group compared with baseline. Moreover, VO2 Max (P = 0.01), VO2/HR (P = 0.04), oxygen uptake/heart rate (VO2/HR) (P = 0.03), and ventilation per minute/oxygen uptake (VE/VO2) (P = 0.03) significantly increased in CFB group compared with control group. In comparison, there was no significant difference in mean ventilation per minute/carbon dioxide production (VE/VCO2) (P = 0.41), ventilation per minute (VE) (P = 0.69), and breathing frequency (P = 0.056). No significant effect of CFB was found on weight, body mass index (P = 0.23), lean body mass (P = 0.91), and body fat mass (P = 0.91). Conclusion: Our results show that intervention with CFB is more effective than regular diet in improving cardiopulmonary function in men athletes who serve in military service.

The effect of statin therapy in combination with ezetimibe on circulating C-reactive protein levels: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Previous studies have reported that statin or ezetimibe therapy has an anti-inflammatory effect. However, the results of individual studies on the effect of statin therapy in combination with ezetimibe on C-reactive protein (CRP) and high-sensitivity CRP (hs-CRP) levels have not been clear. Therefore, the present systematic review and meta-analysis were conducted on randomized clinical trials (RCTs) to evaluate the effect of statin therapy in combination with ezetimibe on CRP and hs-CRP levels. METHODS: A literature search was carried out on the MEDLINE, SciVerse Scopus, and Clarivate Analytics Web of Science databases up to February 2022 to find eligible studies. The pooled effect sizes were considered for weighted mean difference (WMD) and 95% confidence intervals (CI) for CRP and hs-CRP, and it was also determined as standardized weighted mean difference (SMD) for overall CRP. For all variables, a random-effects model was used. RESULTS: Of the 57 studies included in the systematic review, 53 were used for meta-analysis. Statin therapy in combination with ezetimibe significantly reduced the serum levels of hs-CRP (WMD - 0.2 mg/l; 95% CI - 0.4, - 0.1, P ˂ 0.001) and overall CRP (SMD - 0.16 mg/l; 95% CI - 0.2, - 0.07, P ˂ 0.001). Nevertheless, CRP levels were not significantly changed by combination therapy. A significant association was observed between the serum low-density lipoprotein cholesterol (LDL-C) changes and hs-CRP levels, which can justify the source of heterogeneity. CONCLUSIONS: The current study showed that statin therapy in combination with ezetimibe could be effective in reducing the levels of hs-CRP and overall CRP.

Effect of a diet based on Iranian traditional medicine on inflammatory markers and clinical outcomes in COVID-19 patients: A double-blind, randomized, controlled trial.

Introduction: SARS-CoV-2 causes severe acute respiratory syndrome prompting worldwide demand for new antiviral treatments and supportive care for organ failure caused by this life-threatening virus. This study aimed to help develop a new Traditional Persian Medicine (TPM) -based drug and assess its efficacy and safety in COVID-19 patients with major symptoms. Methods: In February 2022, a randomized clinical trial was conducted among 160 patients with a confirmed diagnosis of COVID-19 admitted to Emam Reza (AJA) Hospital in Tehran, Iran. During their hospitalization, the intervention group received a treatment protocol approved by Iran's Ministry of Health and Medical Education (MOHME), consisting of an Iranian regimen, Ficus carica; Vitis vinifera, Safflower, Cicer arietinum, Descurainiasophia seeds, Ziziphus jujuba, chicken soup, barley soup, rose water, saffron, and cinnamon spices. All patients were compared in terms of demographics, clinical, and laboratory variables. Results: One hundred and sixty COVID-19 patients were divided into two groups: intervention and control. In baseline characteristics, there was no significant difference between the intervention and control groups (p>0.05). Using SPSS software version 22, statistical analysis revealed a significant difference in four symptoms: myalgia, weakness, headache, and cough (p<0.05). During the 5-day treatment period, the control group had significantly lower C-reactive protein (p<0.05). Conclusion: While more research with a larger sample size is needed, the proposed combination appears to be effective in the treatment of symptoms as well as inflammatory biomarkers such as C-reactive protein in COVID-19 patients.Iranian registry of clinical trials (IRCT) IRCT20220227054140N1.

Ready-to-Use Therapeutic Food (RUTF) Formulations with Functional Food and Nutrient Density for the Treatment of Malnutrition in Crisis.

Background: Ready-to-use therapeutic food (RUTF) spread has been highly effective in the treatment of malnutrition in those affected by disasters since it does not require preparation and baking and has a long shelf life and sufficient energy to improve growth and weight loss. Such features may be crucial during crises such as wars and natural disasters. The present study aimed to design a high-energy and nutrient-dense RUTF formulation. Methods: Soybean flour and milk protein concentrate were used as protein sources, corn flour, and sugar were employed as carbohydrate sources, cacao butter substitute was used as the lipid source, and vitamin/mineral, beta-alanine, arginine, Nigella sativa, and sesame seeds were used as a functional food. The study was performed in accordance with the guidelines of the Institute of Medicine (IOM) and criteria for food products. Results: To design the formulation, we used carbohydrates (45% of total energy), protein (13% of total energy), fat (42% of total energy), vitamins, minerals, beta-alanine, and arginine, and 100 grams of the diet was considered to release 525 kilocalories of energy. The experimental results of food safety at the determined intervals (at the beginning and 45 and 90 days after the production) showed acceptable values. Conclusions: Since nutritional requirements are among essential human needs (especially in the management of malnutrition in crisis), it is of utmost importance to prepare RUTF products in order to meet all human nutritional needs by facilitating the easy use of these products, particularly for the prevention of malnutrition and diseases.

The effect of Nigella sativa oil on vascular dysfunction assessed by flow-mediated dilation and vascular-related biomarkers in subject with cardiovascular disease risk factors: A randomized controlled trial.

Cardiovascular diseases (CVD) are the leading causes of mortality worldwide. Flow-mediated dilation (FMD) is a marker of vascular function. Beneficial cardiometabolic effects of Nigella sativa (N. sativa) have been observed. We evaluated the effect of N. sativa oil on FMD, plasma nitrite, and nitrate (NOx) as nitric oxide (NO) metabolites, and inflammatory markers in subjects with CVD risk factors. Fifty participants were randomly assigned to either the N. sativa (two capsules of 500 mg N. sativa oil) or the placebo group (two capsules of 500 mg mineral oil), for 2 months. The brachial FMD, plasma NOx, vascular cellular adhesion molecule-1 (VCAM-1), and intracellular adhesion molecule-1 (ICAM-1) were measured. FMD and plasma NOx levels was significantly increased in the N. sativa group compared to the placebo group (changes: 2.97 ± 2.11% vs. 0.71 ± 3.19%, p < 0.001 for FMD and 4.73 ± 7.25 µmol/L vs. 0.99 ± 5.37 µmol/L, p = 0.036 for plasma NOx). However, there was no significant difference in ICAM-1 and VCAM-1 levels between groups. Therefore, N. sativa oil improves vascular NO and FMD in subjects with cardiovascular risk factors. However, more studies are warranted to confirm the beneficial impacts of the N. sativa oil on vascular inflammation.

Nigella sativa in controlling Type 2 diabetes, cardiovascular, and rheumatoid arthritis diseases: Molecular aspects.

Oxidative stress is an important factor in the etiology of several chronic diseases that include cardiovascular disease (CVD), Type 2 diabetes (T2D), and rheumatoid arthritis (RA). Oxidative stress can lead to inflammation, and this can contribute to these chronic diseases. Reducing inflammation and oxidative stress may, therefore, be useful in the prevention and treatment of these conditions. One of the treatment options for chronic diseases is the use of traditional medicine and herbs, such as Nigella sativa. This is one of the herbs that have recently been assessed for its ability to reduce inflammation and oxidative stress. We have reviewed the reported effects of N. sativa on risk factors of chronic diseases (CVD, DM, and RA) with emphasis on molecular and cellular mechanisms in controlling inflammation and oxidative stress. Various mechanisms have been proposed to contribute to the beneficial properties of N. sativa, including a reduction of lipid peroxidation via its antioxidant properties; agonist of peroxisome proliferator-activated receptor gamma in adipose tissue; activation of AMP-activated protein kinase, increased antioxidants, inhibition of nuclear factor-kappa B pathway; increased in interleukin-10 expression, CD4+ T-cell percentage, T regulatory cell percentage (CD4+ CD25+ T-cell) in peripheral blood, and CD4+/CD8+ ratio, but to prove this claim, it is necessary to conduct experimental and well-designed clinical trial studies with a larger sample size on the effects of N. sativa on these chronic diseases.

The effect of food ration bar enriched with ß-alanine, L-arginine, and Nigella sativa on performance and inflammation following intense military training: A double-blind randomized clinical trial.

BACKGROUND: There are growing interests in using dietary supplements to improve athletic performance. This study aimed to evaluate the effect of the food ration bar enriched with ß-alanine, L-arginine, and Nigella sativa on athletic performance and inflammation following intense military training. METHODS: This double-blind, randomized, controlled clinical trial was conducted on 54 new cadets. Eligible participants were randomly assigned in a 1:1 ratio to receive food ration bars enriched with arginine (2 g/day), ß-alanine (2 g/day), and Nigella sativa (2 g/day) or nonenriched food ration bars during a 2-week military training. Aerobic and anaerobic performances were evaluated by the Cooper and RAST tests, respectively. RESULTS: A significant increase in anaerobic powers (min, mean, and max) and a significant reduction in fatigue index were observed in the intervention group as compared to the control group, even after the adjustment for confounding factors. Also, increased levels of hs-CRP and TNF-α following military training were significantly lower in the intervention group as compared to the control group (hs-CRP: 0.55 ± 0.1 versus 2.43 ± 0.1 mg/L; p-value: 0.01; TNF-α: 0.12 ± 0.04 versus 0.62 ± 0.04 pg/ml; p-value: 0.03). No significant changes were observed in VO2 max in both groups. CONCLUSIONS: Our results showed that the combination of ß-alanine, L-arginine, and Nigella sativa can improve anaerobic performance and reduce inflammation following intense physical activities. Further studies with long-term duration are needed to confirm the cumulative/synergic effects of these ingredients in trained and nontrained subjects.

Effect of propolis supplementation on athletic performance, body composition, inflammation, and oxidative stress following intense exercise: A triple-blind randomized clinical trial.

BACKGROUND: Emerging evidence indicates that propolis as a novel potential antioxidant has unique benefits. This study aimed to evaluate the effect of propolis on oxidative stress, inflammation, body composition, and athletic performance in healthy active subjects. METHODS: This clinical trial was conducted on 54 male military cadets. Eligible subjects were randomly allocated to receive a single dose of 450 mg propolis twice daily for four weeks or a matching placebo containing microcrystalline cellulose. Cooper 12-min run test and running-based anaerobic sprint test were performed to measure aerobic and anaerobic performance. Blood samples were obtained immediately after Cooper's test to evaluate oxidative stress and inflammation status. Fat mass and fat-free mass were analyzed using bioelectrical impedance. RESULTS: Mean changes in fat mass, fat-free mass, anaerobic powers, fatigue index, and VO2 max did not differ significantly between the two groups after the adjustment for baseline values (P-value>0.05). A significant change was observed in plasma levels of IL-6 (-1.43 ± 0.11pg/mL), total oxidant status (-3.9 ± 0.2µmol/L), total antioxidant capacity (164 ± 12 µmol/L), malondialdehyde (-0.52 ± 0.03µmol/L), oxidative stress index (-0.45 ± 0.04), and glutathione (48.72±2µmol/L) in the propolis group compared with the placebo group after the adjustment for baseline values and weight changes (P-value<0.05). Although IL-10 concentrations had no significant changes in both groups, the ratio of IL-6/IL-10 significantly reduced in the propolis group compared with the placebo group (-0.174 ± 0.015 versus. 0.051 ± 0.014; P-value: 0.041). CONCLUSIONS: Our results indicated that propolis might have beneficial effects on oxidative stress and inflammation following intense activities in healthy male subjects.

Effect of Nigella sativa oil extract on cardiometabolic risk factors in type 2 diabetes: A randomized, double-blind, placebo-controlled clinical trial.

The objective of this study was to determine the effects of Nigella sativa oil extract on cardiometabolic risk factors in people with type 2 diabetes (T2D). A randomized, controlled, clinical trial was conducted on 43 patients with T2D (23 women and 20 men; aged 53.5 ± 7.4 years). The intervention group (N = 23) received two 500-mg per day soft gel capsules containing Nigella sativa oil extract and the control group (N = 20) received two identical placebo soft gel capsules containing sunflower oil per day for the same period, 8 weeks. Pre- and post-intervention cardiometabolic risk factors were measured. Compared with the placebo, the N. sativa oil significantly decreased FBS (p = .03(, HbA1c (p = .001), total cholesterol (p = .04), TG (p = .003), LDL-c (p = .001), BMI (p < .001), waist circumference (p < .001), SBP (p = .001), and DBP (p = .002). HOMA-IR (p = .51) and HDL-c (p = .91) did not change significantly following Nigella sativa supplementation. Nigella sativa oil exerted beneficial effects on glycemic control, serum lipid profile, blood pressure, and body weight among people with T2D. Further long-term trials in the future may help confirm the current therapeutic benefits of Nigella sativa in T2D.

Effects of Nigella sativa oil extract on inflammatory cytokine response and oxidative stress status in patients with rheumatoid arthritis: a randomized, double-blind, placebo-controlled clinical trial.

OBJECTIVE: Nigella sativa is a medicinal plant that has long been used in traditional medicine for treating various conditions. Numerous animal studies provided evidences that the seed may elicit a broad anti-inflammatory/anti-oxidant activity. The aim of the present clinical trial was to evaluate anti-inflammatory and antioxidant properties of Nigella sativa oil in patients with rheumatoid arthritis (RA). MATERIALS AND METHODS: Forty-two patients with RA were assigned into two groups in this randomized, double blind, placebo-controlled clinical trial. Subjects in intervention group received two capsules, 500 mg each, of Nigella sativa oil, each day for 8 weeks. The other group consumed two capsules as placebo per day for the same period of time. Serum TNF-α, IL-10, and whole blood levels of oxidative stress parameters were measured at baseline and end of the trial. RESULTS: The serum level of IL-10 was increased in the Nigella sativa group (p<0.01). Moreover, treatment with Nigella sativa led to significant reduction of serum MDA and NO compared with baseline (p<0.05). There were no significant differences in the TNF-α, SOD, catalase, and TAS values between or within the groups, before and after the intervention (p>0.05). CONCLUSION: This study indicates that Nigella sativa could improve inflammation and reduce oxidative stress in patients with RA. It is suggested that Nigella sativa may be a beneficial adjunct therapy in this population of patients.