The effects of jujube (Ziziphus jujube) on metabolic and mental health outcomes in patients with metabolic syndrome: A randomized controlled trial.

OBJECTIVES: The effects of jujube (Ziziphus jujube) consumption on metabolic and mental health outcomes in subjects diagnosed with metabolic syndrome (MetS) is unknown and remains to be examined. Hence, we carried out a parallel-group, randomized controlled trial to investigate this issue. METHODS: Eligible participants were randomly assigned to the intervention (n = 30) or the control (n = 30) groups to receive either jujube or a placebo for eight weeks. Subjects were provided with 30 g dried jujube powder or placebo and were asked to consume half of the powder at 10 a.m. and the rest at 4 p.m. Lipid profile, fasting blood glucose (FBG), waist circumference (WC), and blood pressure were evaluated as primary outcomes. Secondary outcomes collected were mental health measures (e.g., depression, anxiety, and stress). RESULTS: Jujube consumption failed to decrease FBG, total cholesterol, low-density lipoprotein cholesterol, and blood pressure, as well as depression and anxiety scores (P > 0.05). However, the between-group comparison revealed a significant improvement in WC (- 3.98 vs. - 0.51, P = 0.01), triglyceride (TG) (- 24.96 vs. - 0.73, P = 0.03), and high-density lipoprotein cholesterol (HDL-C) (2.83 vs. 0.40, P = 0.01) in the jujube group compared to the placebo. In addition, compared to the control group, jujube consumption led to a significant improvement in the score of stress (- 5.80 vs. - 2.86, P = 0.01). CONCLUSION: Jujube consumption only had beneficial effects on WC, TG, and HDL-C in subjects with MetS. However, the current study has methodological weaknesses in blinding and herb purity/potency testing, which should be addressed in future studies.

Coenzyme Q10 supplementation in burn patients: a double-blind placebo-controlled randomized clinical trial.

BACKGROUND: Burn injuries are important medical problems that, aside from skin damage, cause a systemic response including inflammation, oxidative stress, endocrine disorders, immune response, and hypermetabolic and catabolic responses which affect all the organs in the body. The aim of this study was to determine the effect of coenzyme Q10 (CoQ10) supplementation on inflammation, oxidative stress, and clinical outcomes in burn patients. METHODS: In a double-blind placebo-controlled randomized clinical trial, 60 burn patients were randomly assigned to receive 100 mg CoQ10 three times a day (total 300 mg/day) or a placebo for 10 days. Inflammatory markers including erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), oxidative stress markers including total antioxidant capacity (TAC), malondialdehyde (MDA) and superoxide dismutase (SOD) activity, fasting blood glucose (FBG), blood urea nitrogen (BUN), creatinine, white blood cells (WBC), and body temperature were assessed as primary outcomes and albumin, prothrombin time (PT), partial thromboplastin time (PTT), international normalized ratio (INR), other hematological parameters, blood pressure, O2 saturation, ICU duration, and 28-mortality rate were assessed as secondary outcomes. RESULTS: Fifty-two participants completed the trial. CRP and ESR levels were not significantly different between CoQ10 and placebo groups at the end of the study (P = 0.550 and P = 0.306, respectively). No significant differences between groups were observed for TAC (P = 0.865), MDA (P = 0.692), and SOD activity (P = 0.633) as well. Administration of CoQ10 resulted in a significant increase in albumin levels compared to placebo (P = 0.031). There was no statistically significant difference between the two groups in other measured outcomes (P > 0.05). CONCLUSION: Results showed that in patients with burn injury, CoQ10 administration had no effect on inflammatory markers and oxidative stress, although serum albumin levels were improved after supplementation. Further studies with albumin as the primary outcome are needed to confirm this finding.

The effect of selenium supplementation on oxidative stress, clinical symptoms and mental health status in patients with migraine: a study protocol for a double-blinded randomized clinical trial.

BACKGROUND: Despite a number of recommended strategies, effective treatment of migraine remains elusive. Given the role of oxidative stress in the pathogenesis of migraine, selenium, as an antioxidant nutrient, may have a beneficial effect on migraine outcomes. However, no study has explored the effects of selenium supplementation on migraine symptoms, oxidative stress biomarkers, and mental health. Therefore, this randomized, double-blinded, placebo-controlled clinical trial aims to examine the effects of selenium supplementation among migraine patients. METHODS: Seventy-two migraine patients will receive either 200 µg/day selenium supplement (n = 36) or placebo (n = 36) for 12 weeks in a randomized, double-blinded, placebo-controlled study. The severity, frequency, and duration of headaches, mental health indices including depression, anxiety, and distress, and quality of life, as well as biomarkers of oxidative stress such as nitric oxide (NO), malondialdehyde (MDA), total antioxidant capacity (TAC), and total oxidant status (TOS), will be measured at the baseline and end of the study. The intention-to-treat (ITT) approach will be used to estimate missing values. One-way analysis of covariance (ANCOVA) will be performed to detect the effect of selenium supplementation on outcome variables. DISCUSSION: Oxidative stress is recognized as a key contributor to migraine pathogenesis. Selenium is an essential trace element with antioxidant properties, capable of crossing the blood-brain barrier (BBB), holding promise to alleviate the oxidative stress and neurotoxicity. Thus, selenium may beneficially affect clinical symptoms and oxidative stress as well as the quality of life in migraine patients. TRIAL REGISTRATION: This trial was registered in the Iranian Registry of Clinical Trials ( https://www.irct.ir/ ) on 27 May 2023 with the code number IRCT20121216011763N60.

The effects of L-carnitine supplementation on inflammation, oxidative stress, and clinical outcomes in critically Ill patients with sepsis: a randomized, double-blind, controlled trial.

BACKGROUND: Sepsis, a life-threatening organ dysfunction caused by a host's dysregulated response to infection with an inflammatory process, becomes a real challenge for the healthcare systems. L-carnitine (LC) has antioxidant and anti-inflammatory properties as in previous studies. Thus, we aimed to determine the effects of LC on inflammation, oxidative stress, and clinical parameters in critically ill septic patients. METHODS: A randomized double-blinded controlled trial was conducted. A total of 60 patients were randomized to receive LC (3 g/day, n = 30) or placebo (n = 30) for 7 days. Inflammatory and oxidative stress parameters (C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), superoxide dismutase (SOD), malondialdehyde (MDA), total antioxidant capacity (TAC), 28-day mortality rate, and some monitoring variables were evaluated. RESULTS: There was no statistically significant difference between study arms in baseline characteristics and disease severity scores. CRP (p < 0.001) and ESR (p: 0.004) significantly reduced, and SOD (p < 0.001) and TAC (p < 0.001) significantly improved in the LC group after 7 days. Between-group analysis revealed a significant reduction in CRP (p: 0.001) and serum chloride (p: 0.032), an increase in serum albumin (p: 0.036) and platelet (p: 0.004) significantly, and an increase in SOD marginally (p: 0.073). The 28-day mortality rate was also lower in the LC group compared with placebo (7 persons vs. 15 persons) significantly (odds ratio: 0.233, p: 0.010). CONCLUSIONS: L-carnitine ameliorated inflammation, enhanced antioxidant defense, reduced mortality, and improved some clinical outcomes in critically ill patients with sepsis. TRIAL REGISTRATION: IRCT20201129049534N1; May 2021.

Effect of sesame supplementation on body composition and lipid profile in patients with type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials.

AIMS: The aim of this study was to conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) that evaluated the impact of sesame supplementation on body weight (BW), body mass index (BMI), triglycerides (TGs), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), and high-density lipoprotein-cholesterol (HDL-C) in patients with type 2 diabetes mellitus (T2DM). DATA SYNTHESIS: PubMed, Scopus, ISI Web of Science, and Embase were searched without any restrictions until September 2023.Only RCTs reporting the effects of sesame supplementation on body composition and lipid profiles were included, while observational studies and animal models were excluded. The methodological quality of the studies was assessed using the Cochrane risk of bias tool. Out of 997 studies identified, 10 were included in the systematic review and meta-analysis. Our meta-analysis suggested a significant association between sesame supplementation and reduction in TG (weighted mean difference (WMD): -37.61 mg/dl, 95 % CI: -61.48, 13.73), TC (WMD: -32.69 mg/dl, 95 % CI: -47.26, 18.12), and LDL-C (WMD: -28.72 mg/dl, 95 % CI: -44.68, 12.76). However, our meta-analysis indicated that the supplementary intake of sesame had no significant effect on HDL-C, BW, and BMI in patients with T2DM. CONCLUSIONS: This study showed that sesame consumption significantly lowered TG, TC, and LDL-C levels, which may have contributed to the improvement of clinical symptoms in T2DM. However, given the limited number of trials included in the analysis, additional large-scale studies are needed to confirm the effects of sesame consumption on the lipid profile and body composition in patients with T2DM. PROSPERO CODE: CRD42023460630.

Effect of Zinc Supplementation on Lipid Profile and Body Composition in Patients with Type 2 Diabetes Mellitus: A GRADE-Assessed Systematic Review and Dose-Response Meta-analysis.

The aim of this systematic review and meta-analysis of randomized controlled trials (RCTs) is to investigate the overall effects of zinc supplementation on lipid profile and body composition such as body weight (BW), body mass index (BMI), triglycerides (TG), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), and high-density lipoprotein-cholesterol (HDL-C) in patients with type 2 diabetes mellitus (T2DM). Scopus, Web of Science, PubMed, and Embase databases were searched from inception through October, 2023. The I2 and Cochran's Q tests were used to assess heterogeneity between studies. Nineteen RCTs (n = 1357 participants) were included in the meta-analysis. Zinc supplementation significantly reduced TG (WMD = - 17.41 mg/dL; 95% CI: - 22.60, - 12.22; P < 0.001), TC (WMD: - 19.60 mg/dL; 95% CI: - 28.46, - 10.73, P < 0.001), LDL-C (WMD = - 8.80 mg/dL; 95% CI: - 14.80, - 2.81; P = 0.004), and BMI (WMD = - 0.53 kg/m2; 95% CI: - 1.05, - 0.01; P = 0.046) but not BW (WMD: - 0.51 kg, 95 % CI: - 1.99, 0.97, P = 0.498). Moreover, zinc supplementation increased HDL-C (WMD = 4.82 mg/dL; 95% CI: 0.88, 8.76; P = 0.016) in patients with T2DM. Our results propose that zinc supplementation may be an effective strategy for improving lipid profile and body composition in patients with T2DM.

What is the influence of policosanol supplementation on liver enzymes? A systematic review and dose-response meta-analysis of randomized controlled trials.

OBJECTIVE: Policosanol is a mixture of long chain alcohols refined from sugar cane. Significant reductions in liver enzymes have been observed in some studies. However, the impact of policosanol on liver enzymes remained controversial. The current meta-analysis aims to evaluate the effect of policosanol supplementation on the levels of alanine transaminase (ALT) and aspartate transaminase (AST). METHODS: The literature was systematically searched for studies published up to November 2023 in PubMed/Medline, Google Scholar, EMBASE, and Scopus. Randomized controlled trial (RCT) studies were included to evaluate the intervention effect of policosanol compared to placebo on ALT and AST. DerSimonian and Laird models were used to calculate effect sizes. RESULTS: Twenty-three trials including 2535 participants were included in the study. The combination of effect sizes, regarding the random-effects model, demonstrated significant changes in ALT serum levels after intervention (WMD: -1.48 U/L; 95% CI: -2.33 to -0.64; P = 0.001), and AST (WMD: -1.10 U/L; 95% CI: -1.70 to -0.51; P < 0.001). Subgroup analysis of AST and ALT showed that this reduction effect was most often observed at the dose of 20 mg/d. The dose-response analysis represented a non-significant non-linear connection between the dosage and duration of policosanol intervention in ALT and AST serum reduction. CONCLUSION: Policosanol supplementation exerts a beneficial effect on liver enzymes as well as ALT and AST concentrations in adults. However, further long-term and well-designed RCTs with better quality are needed to further assess and confirm these results.

Characterization of novel alginate-Aloe Vera raft systems for treatment of gastroesophageal reflux disease.

Raft-forming systems are designed to relieve reflux symptoms by forming a physical barrier on top of the stomach. The present study aimed to evaluate the physico-chemical properties of alginate-aloe vera raft-forming systems for the first time. To achieve this goal, aloe vera was used in the proportion of 1 and 1.5 % in raft suspensions containing 5 % alginate as the main component of gel structure. Rafts were characterized by their volume, floating behavior, thickness, swelling properties, strength, resilience, reflux resistance, and acid neutralization capacity (ANC). Results showed the effectiveness of aloe vera in forming rafts that were voluminous, buoyant with greater total floating time (TFT), and stronger than formulations with no aloe vera. Furthermore, data showed that the presence of aloe vera could improve resilience time, swelling proportions, resistance to reflux under simulant conditions of movement in the stomach, and ANC values of rafts. Rafts were further characterized by oscillatory strain sweep test, differential scanning calorimetry, and Fourier transform infrared spectroscopy. Evaluation of the mechanical properties of rafts displayed a viscoelastic behavior of gels corresponding to the internal cross-linked structure of rafts. This study demonstrated that designing of alginate-aloe vera rafts can be suitable for the treatment of gastro-esophageal reflux disorders.

Effects of chromium supplementation on body composition in patients with type 2 diabetes: A dose-response systematic review and meta-analysis of randomized controlled trials.

INTRODUCTION: Several randomized controlled trials (RCTs) have demonstrated the beneficial effects of chromium supplementation in managing type 2 diabetes mellitus (T2DM). The current systematic review and meta-analysis aimed to investigate the associations between chromium supplementation and body composition in patients with T2DM. METHODS: To achieve this, PubMed, Scopus, Embase, Cochrane Library, and Web of Science were searched for randomized clinical trials (RCTs) that reported the effects of chromium supplementation on body composition such as body weight (BW), body mass index (BMI), fat mass (FM), and waist circumference (WC) in patients with T2DM from inception until July 2023. Weighted mean differences (WMDs) with 95% confidence intervals (CIs) were calculated using a fixed-effects model. RESULTS: The meta-analysis included a total of 14 RCTs. The results showed that chromium supplementation did not have any significant effect on FM (WMD = -0.43%; 95% CI -0.94, 0.09), BMI (WMD: 0.09 kg/M2, 95% CI: -0.03, 0.20), WC (WMD: -0.47 cm, 95% CI: -1.10, 0.16), and BW (WMD: -0.26 kg, 95% CI: -0.69, 0.16). However, subgroup analysis revealed that chromium intake decreased FM in subjects aged ≥ 55 years and when chromium picolinate was used as an intervention. Additionally, there was a non-linear association between the dose of chromium supplementation and BW. CONCLUSIONS: The meta-analysis suggests that chromium supplementation does not significantly reduce BW, BMI, WC, and FM in patients with T2DM. Further RCTs with large-scale are required to determine the possible anti-obesity effects of chromium in patients with T2DM.

The effects of curcumin-piperine supplementation on inflammatory, oxidative stress and metabolic indices in patients with ischemic stroke in the rehabilitation phase: a randomized controlled trial.

BACKGROUND: Stroke is a leading cause of death worldwide, which is associated with a heavy economic and social burden. The purpose of this study was to investigate the effects of supplementation with curcumin-piperine combination in patients with ischemic stroke in the rehabilitation stage. METHODS: In this randomized controlled trial, 66 patients with stroke were randomized into two groups receiving curcumin-piperine tablets (500 mg curcumin + 5 mg piperine) and matched placebo tablets for 12 weeks. High-sensitivity C-reactive protein (hs-CRP), carotid intima-media thickness (CIMT), thrombosis, total antioxidant capacity (TAC), lipid profile, anthropometric indices, blood pressure, and quality of life were assessed before and after the intervention. Statistical data analysis was done using SPSS22 software. RESULTS: A total of 56 patients with a mean age of 59.80 ± 4.25 years completed the trial. Based on ANCOVA test, adjusted for baseline values, curcumin-piperine supplementation for 12 weeks resulted in significant reductions in serum levels of hs-CRP (p = 0.026), total cholesterol (TC) (p = 0.009), triglycerides (TG) (p = 0.001), CIMT (p = 0.002), weight (P = 0.001), waist circumference (p = 0.024), and systolic and diastolic blood pressure (p < 0.001), and a significant increase in TAC (p < 0.001) in comparison to the placebo. Pain score significantly increased in both groups; however, its increase was significantly higher in the placebo group compared with the intervention group (p = 0.007). No significant changes were observed between the two groups in terms of serum fibrinogen, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and quality of life indices. CONCLUSION: Curcumin-piperine supplementation had beneficial effects on CIMT, serum hs-CRP, TC, TG, TAC, and systolic and diastolic blood pressure in patients with ischemic stroke in the rehabilitation stage.

Effect of inulin supplementation on clinical symptoms, inflammatory and oxidative stress markers in women with migraine: study protocol for a randomized clinical trial.

BACKGROUND: Migraine is a complex, chronic, and debilitating multifactorial disorder characterized by recurrent episodes of headache and related symptoms. It typically begins in early ages and is more prevalent in women than in men. Recently, the gut-brain axis has emerged as a new candidate that may be linked to neurological diseases. We hypothesize that selective modulation of the intestinal microbiota, oxidative stress, and inflammation through inulin supplementation may improve clinical outcomes in these patients. Therefore, this study aims to examine the effects of high-performance inulin supplementation on clinical symptoms, mental health, quality of life (QOL), intestinal permeability, and inflammatory and oxidative stress factors in women with migraine. METHODS: This is a randomized, double-blind, placebo-controlled clinical trial involving 80 women with migraine who meet the inclusion criteria (aged between 20 and 50 years with a diagnosis of migraine by a neurologist based on the ICDH-3). Participants will be assigned to receive a daily dose of 10 g of inulin for 12 weeks (intervention group, n = 40) or 10 g of maltodextrin as a placebo for the same duration (control group, n = 40). The primary outcome will measure the variations in the frequency of headache experienced by the patients. Secondary outcomes will encompass serum levels of zonulin, high-sensitive C-reactive protein, total antioxidant capacity, total oxidant status, nitric oxide, mental status, QOL, duration, and severity of migraine attacks. DISCUSSION: This clinical trial aims to evaluate the effect of inulin supplementation on inflammatory status, oxidative stress, intestinal permeability, clinical symptoms, mental health, and QOL in women with migraine. The findings of this trial could contribute to the identification of mechanistic action and evidence-based clinical guidelines that address gut microbiota manipulation to maximize health benefits in the management of clinical outcomes in migraine patients. TRIAL REGISTRATION: Iranian Registry of Clinical Trials ( www.irct.ir ) (ID: IRCT20121216011763N58). Registration date: 23 April 2023. TRIAL STATUS: The protocol is version 3.0, September 17, 2023. Recruitment began August 21, 2023, and is anticipated to be completed by March 22, 2024.

The effects of alpha lipoic acid (ALA) supplementation on blood pressure in adults: a GRADE-assessed systematic review and dose-response meta-analysis of randomized controlled trials.

Introduction: There have been various clinical studies on the effect of Alpha lipoic acid (ALA) supplementation on blood pressure (BP), but the findings from these are contradictory. Therefore, we performed a systematic review and dose-response meta-analysis to summarize the relation of ALA supplementation and systolic blood pressure (SBP) and diastolic blood pressure (DBP) in adults. Methods: A comprehensive search was conducted in Medline (PubMed), Embase, Scopus, and ProQuest up to July 2023. Randomized controlled trials (RCTs) evaluating the effect of ALA on SBP and DBP were included. The pooled weighted mean difference (WMD) of included trials was estimated using a random-effects model. The dose-dependent effect was also assessed. Results and discussion: A total of 11 RCTs with the participation of 674 patients were included. The result of the meta-analysis indicated that using ALA supplementation significantly reduced the SBP (WMD = -5.46 mmHg; 95% CI: -9.27, -1.65; p < 0.001) and DBP (WMD = -3.36 mmHg, 95% CI: -4.99, -1.74; p < 0.001). The ALA administrations significantly reduced SBP and DBP at the dosages of <800 mg/day, when administered for ≤12 weeks. The present meta-analysis revealed that ALA supplementation could exert favorable effects on SBP and DBP. Further well-designed studies with larger samples are needed to ascertain the long-term effects of ALA on BP. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=447658, identifier PROSPERO: CRD42023447658.

Effects of marine-derived n-3 PUFA supplementation on soluble adhesion molecules: A systematic review and dose-response meta-analysis of randomized controlled trials.

Long-chain n-3 poly unsaturated fatty acids have anti-inflammatory effects but their effects on serum levels of adhesion molecules are inconsistent and contradictory. In this updated systematic review and meta-analysis, marine sources of omega-3 fatty acids were pooled up to determine the effects of omega-3 supplementation on adhesion molecules. PubMed-Medline, SCOPUS, Web of Science and Google Scholar databases (from inception to April 2023) were searched and all RCTs investigating the effects of marine sources of omega-3, on blood concentrations of adhesion molecules were included and a meta-analysis undertaken. Forty-two RCTs were included involving 3555 participants aged from 18 to 75 years. Meta-analysis of 38 arms from 30 RCTs reporting serum concentrations of vascular cell adhesion molecule-1 (VCAM-1) showed a significant reduction after omega-3 supplementation (WMD: -1.26, 95% CI: -1.88 to -0.64 ng/mL, P < 0.001). Meta-analysis of 40 arms from 30 RCTs reporting serum concentrations of intercellular adhesion molecule-1 (ICAM-1) revealed a reduction following omega-3 supplementation, although it was not significant (WMD: -1.76, 95%CI: -3.68 to 0.16 ng/mL, P = 0.07). Meta-analysis of 27 arms from 21 trials showed no effect on E-selectin (WMD: 0.01, 95%CI: -0.02 to 0.04 ng/mL, P = 0.62). Pooling 15 arms from 11 RCTs showed a marginally significant reducing effect on P-selectin concentrations (WMD: -2.67, 95%CI: -5.53 to 0.19 ng/mL, P = 0.06). A considerable decrease in VCAM concentration was observed after omega-3 supplementation in this meta-analysis with a trend to decreases in both ICAM and P-selectin levels, with effects that may be significant depending on study design, and there was no effect on E-selectin.

Effect of soluble fiber on blood pressure in adults: a systematic review and dose-response meta-analysis of randomized controlled trials.

OBJECTIVES: Pervious epidemiologic evidence indicates that soluble fiber is protective against hypertention: however, randomized controlled trials (RCTs) have presented varying results. In the present study, we aimed to conduct a systematic review and dose-response meta-analysis to summarize published RCTs which assess the effect of soluble fiber supplementation on systolic blood pressure (SBP) and diastolic blood pressure (DBP). METHODS: Scopus, PubMed, and ISI Web of Sciences were searched to identify relevant studies up to Aug 2022. We estimated the change in blood pressure for each 5 g/d increment in soluble fiber supplementation in each trial and then calculated the weighted mean difference (WMD) and 95%CI using a random-effects model. We estimated dose-dependent effects using a dose-response meta-analysis of differences in means. The risk of bias for study was assessed using the Cochrane tool. Publication bias was evaluated via funnel plot and Begg's test and Egger's test. RESULTS: Eighty-three eligible studies with total sample size of 5,985 participants were included in the meta-analysis. Soluble fiber supplementation significantly decreased SBP (WMD: -1.36 mmHg, 95% CI: -2.13 to -0.60, P < 0.001; I2 = 47.1%, P < 0.001) and DBP (WMD: -0.72 mmHg, 95% CI: -1.26 to -0.18, P = 0.009; I2 = 45.4%, P < 0.001). Each 5 g/d increment in soluble fiber supplementation had a significant reduction in SBP (WMD: -0.54 mmHg; 95%CI: -0.86, -0.22, P = 0.001; I2 = 52.2, Phet < 0.001) and DBP (WMD: -0.28 mmHg; 95%CI: -0.49, -0.80, P = 0.007; I2 = 43.1%, Phet < 0.001). The levels of SBP decreased proportionally with the increase in soluble fiber supplementation up to 20 g/d (MD20g/d: -1.79 mmHg, 95%CI: -2.86, -0.71). CONCLUSION: Current evidence indicated the beneficial effect of soluble fiber supplementation on blood pressure. Our findings suggest that soluble fiber supplementation could contribute to the management of hypertension and the reduction of cardiovascular disease risk.

The effects of propolis supplementation on high-sensitivity C-reactive protein, testosterone hormone, and metabolic profile in women with polycystic ovary syndrome: A randomized, triple-blinded, placebo-controlled clinical trial.

One of the most prevalent ovulation disorders is polycystic ovarian syndrome (PCOS). According to the anti-inflammatory and beneficial effects of propolis, this triple-blind controlled trial was designed to evaluate the effect of propolis on metabolic factors, high-sensitivity C-reactive protein, and testosterone in women with PCOS. Recruited patients from the gynecologist clinic were randomized based on a stratified permuted four-block randomization procedure to supplement with propolis tablets, two tablets/day (500 mg propolis/day) (n = 30) or identical placebo tablets (n = 30) for 12 weeks in 2021 until 2022. Data were collected using a demographic questionnaire, blood samples, and a checklist to record the measured parameters. A total of 57 patients completed the trial. ANCOVA test showed that hip circumference (HC)) p = 0.03), fasting insulin (p = 0.007), homeostatic model assessment for insulin resistance (p = 0.004), testosterone (p = 0.004), and low-density lipoprotein (LDL)/high-density lipoprotein (HDL) (p = 0.02) were significantly decreased in the propolis versus the placebo group after adjustment for confounders. Although fasting blood glucose (p = 0.04) decreased significantly in the propolis group compared to the placebo, after adjusting for confounders, significance was lost (p = 0.09). Supplementation with propolis elicited positive effects on fasting insulin and insulin resistance, in addition to reducing the testosterone level, LDL/HDL, and HC, in PCOS women.

The effect of selenium supplementation on sonographic findings of salivary glands in papillary thyroid cancer (PTC) patients treated with radioactive iodine: study protocol for a double-blind, randomized, placebo-controlled clinical trial.

BACKGROUND: Thyroid cancer is a very damaging disease. The most common treatment for this disease includes thyroidectomy and then using radioactive iodine (RAI). RAI has many side effects, including a decrease in salivary secretions, followed by dry mouth and oral and dental injuries, as well as increased inflammation and oxidative stress. Selenium can be effective in these patients by improving inflammation and oxidative stress and by modulating salivary secretions. So far, only one clinical trial has investigated the effect of selenium on thyroid cancer patients treated with radioiodine therapy (RIT) conducted on 16 patients; considering the importance of this issue, to show the potential efficacy of selenium in these patients, more high-quality trials with a larger sample size are warranted. METHODS: This is a parallel double-blind randomized controlled clinical trial that includes 60 patients aged 20 to 65 years with papillary thyroid cancer (PTC) treated with RAI and will be conducted in Seyyed al-Shohada Center, an academic center for referral of patients to receive iodine, Isfahan, Iran. Thirty patients will receive 200 µg of selenium for 10 days (3 days before to 6 days after RAI treatment) and another 30 patients will receive a placebo for the same period. Sonographic findings of major salivary glands, salivary secretions, and sense of taste will be evaluated before and 6 months after 10-day supplementation. DISCUSSION: Due to its anti-inflammatory and antioxidant effects, as well as improving salivary secretions, selenium may improve the symptoms of thyroid cancer treated with radioactive iodine. In past studies, selenium consumption has not reduced the therapeutic effects of radiation therapy, and at a dose of 300 to 500 µg/day, it has not had any significant side effects in many types of cancer under radiation therapy. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20201129049534N6 . Registered on 16 September 2021.

Is there an association between a plant-based eating pattern and clinical findings of a migraine headache?

Aims: The present study was conducted among Iranian individuals diagnosed with migraine headaches to investigate the association between plant-based eating patterns and the clinical features of a migraine headache. Methods: In total, 262 patients aged 20-50 years who were diagnosed with migraine headaches were included in the current cross-sectional study. Participants' dietary intake was assessed using a validated 168-item, semi-quantitative food frequency questionnaire (FFQ). Three versions of the plant-based diet index (PDI) comprising overall PDI, healthy PDI (hPDI), and unhealthy PDI (uPDI) were generated. Headache frequency, duration, and severity were assessed via a 30-day headache diary. Migraine-related disability was assessed with a validated version of the headache impact test (HIT-6) questionnaire. Serum nitric oxide (NO) was measured using the Griess method utilizing serum samples. Results: After controlling for potential confounders, an increase in mean PDI score from 48.22 to 61.67 decreased the frequency of headaches by -2.95 (95% CI: 0.06, 0.53; ptrend = 0.005). PDI was inversely associated with serum levels of NO in those with the highest scores of PDI compared to those with the lowest scores after adjustment for confounders (ß = -7.69; 95% CI: -14.68, -0.69; ptrend = 0.028). After adjustment for potential confounders, an increase in the mean hPDI score from 47.96 to 65.25 decreased serum levels of NO by -11.92 (95% CI: -19.74, -4.10; ptrend = 0.003). Conclusion: Our findings suggest that higher adherence to a plant-based eating style, as evidenced by higher PDI and hPDI values, was significantly associated with lower headache frequency and serum levels of NO.

Spices and Biomarkers of COVID-19: A Mechanistic and Therapeutic Perspective.

In the face of the COVID-19 pandemic, many people around the world have increased their healthy behaviors to prevent transmission of the virus and potentially improve their immune systems. Therefore, the role of diet and food compounds such as spices with bioactive and antiviral properties may be important in these efforts. In this chapter, we review the efficacy of spices such as turmeric (curcumin), cinnamon, ginger, black pepper, saffron, capsaicin, and cumin by investigating the effects of these compounds of COVID-19 disease severity biomarkers.

Antiviral Mechanisms of Curcumin and Its Derivatives in Prevention and Treatment of COVID-19: A Review.

The COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has now plagued the world for almost 3 years. Although vaccines are now available, the severity of the pandemic and the current dearth of approved effective medications have prompted the need for novel treatment approaches. Curcumin, as a food nutraceutical with anti-inflammatory and antioxidant effects, is now under consideration for the prevention and treatment of COVID-19. Curcumin has been demonstrated to retard the entrance of SARS-CoV-2 into cells, interfere with its proliferation inside cells, and curb the hyperinflammatory state caused by the virus by modulating immune system regulators, minimizing the cytokine storm effect, and modulating the renin-angiotensin system. This chapter discusses the role of curcumin and its derivatives in the prevention and treatment of COVID-19 infection, considering the molecular mechanisms involved. It will also focus on the molecular and cellular profiling techniques as essential tools in this research, as these can be used in the identification and development of new biomarkers, drug targets, and therapeutic approaches for improved patient care.

Evaluation of Curcumin-Piperine Supplementation in COVID-19 Patients Admitted to the Intensive Care: A Double-Blind, Randomized Controlled Trial.

BACKGROUND: Curcumin is a traditional remedy for diseases associated with hyper-inflammatory responses and immune system impairment. Piperine, a bioactive compound in black pepper, has the potential to enhance curcumin bioavailability. 0This study aims to examine the effect of the curcumin-piperine co-supplementation in patients infected with SARS-CoV-2 and admitted to the intensive care unit (ICU). MATERIAL AND METHODS: In this parallel randomized, double-blind, placebo-controlled trial, 40 patients with COVID-19 admitted to ICU were randomized to receive three capsules of curcumin (500 mg)-piperine (5 mg) or placebo for 7 days. RESULTS: After 1 week of the intervention, serum aspartate aminotransferase (AST) (p = 0.02) and C-reactive protein (CRP) (p = 0.03) were significantly decreased, and hemoglobin was increased (p = 0.03) in the curcumin-piperine compared to the placebo group. However, compared with the placebo, curcumin-piperine had no significant effects on the other biochemical, hematological, and arterial blood gas and 28-day mortality rate was three patients in each group (p = 0.99). CONCLUSION: The study results showed that short-term curcumin-piperine supplementation significantly decreased CRP, AST, and increased hemoglobin in COVID-19 patients admitted to the ICU. Based on these promising findings, curcumin appears to be a complementary treatment option for COVID-19 patients, although some parameters were not affected by the intervention.