Association of plant-based dietary patterns with the risk of type 2 diabetes mellitus using cross-sectional results from RaNCD cohort.

The prevalence of type 2 diabetes mellitus (T2DM) is increasing in middle- and low-income countries, and this disease is a burden on public health systems. Notably, dietary components are crucial regulatory factors in T2DM. Plant-based dietary patterns and certain food groups, such as whole grains, legumes, nuts, vegetables, and fruits, are inversely correlated with diabetes incidence. We conducted the present study to determine the association between adherence to a plant-based diet and the risk of diabetes among adults. We conducted a cross-sectional, population-based RaNCD cohort study involving 3401 men and 3699 women. The plant-based diet index (PDI) was developed using a 118-item food frequency questionnaire (FFQ). Logistic regression models were used to evaluate the association between the PDI score and the risk of T2DM. A total of 7100 participants with a mean age of 45.96 ± 7.78 years were analysed. The mean PDI scores in the first, second, and third tertiles (T) were 47.13 ± 3.41, 54.44 ± 1.69, and 61.57 ± 3.24, respectively. A lower PDI was significantly correlated with a greater incidence of T2DM (T1 = 7.50%, T2 = 4.85%, T3 = 4.63%; P value < 0.001). Higher PDI scores were associated with significantly increased intakes of fibre, vegetables, fruits, olives, olive oil, legumes, soy products, tea/coffee, whole grains, nuts, vitamin E, vitamin C, and omega-6 fatty acids (P value < 0.001). After adjusting for confounding variables, the odds of having T2DM were significantly lower (by 30%) at T3 of the PDI than at T1 (OR = 0.70; 95% CI = 0.51, 0.96; P value < 0.001). Our data suggest that adhering to plant-based diets comprising whole grains, fruits, vegetables, nuts, legumes, vegetable oils, and tea/coffee can be recommended today to reduce the risk of T2DM.

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 relationship of dietary inflammatory index and dietary patterns with premenstrual syndrome among women in Kermanshah: An analytical cross-sectional study.

Premenstrual syndrome (PMS) is a common psychological condition that occurs continuously during the luteal phase of the menstrual cycle. Potential factors in this syndrome comprise the central nervous system, hormones, genetic background, and nutritional indicators. Little is known about foods or eating patterns that may be associated with this syndrome, yet nutritional factors can be considered in strategies for the management of PMS. The current study purposed to investigate the relationship between PMS and dietary inflammation index as well as PMS and food patterns. The present cross-sectional study was conducted on 125 women and girls aged 20-46 years who experienced symptoms of PMS. The inclusion criteria included cooperation and consent to enter the study, a body mass index of 18.5-25 kg/m2, no underlying disease, no use of contraceptives or antidepressants, and no use of multivitamin or mineral supplements. In the first stage of this study, participants' height, weight, waist circumference, and hip circumference were measured. In the second stage, eating habits were examined using a semiquantitative Food Frequency Questionnaire. This study found a significant correlation between glycemic load quintiles as well as between energy and macronutrient intake and the dietary inflammatory index; however, it revealed a direct correlation between PMS and both Western-mixed dietary and high-salt-high-sugar dietary patterns. Moreover, the Western food pattern was found to have a direct correlation with dietary inflammatory index, and the healthy food pattern had an inverse correlation with this index. This study showed that PMS symptoms are more severe with the consumption of high-salt-high-sugar or a Western-mixed food dietary pattern. It seems that an imbalance in hormones and neurotransmitters can affect the metabolism of proteins, carbohydrates, and fats. Also, some foods, such as vegetables, and low-fat and high-fiber diets reduce plasma estrogen levels and the duration of PMS symptoms.

The efficacy of curcumin-piperine co-supplementation on clinical symptoms, duration, severity, and inflammatory factors in COVID-19 outpatients: a randomized double-blind, placebo-controlled trial.

BACKGROUND: COVID-19 pandemic has made the disease a major global problem by creating a significant burden on health, economic, and social status. To date, there are no effective and approved medications for this disease. Curcumin as an anti-inflammatory agent can have a positive effect on the control of COVID-19 complications. This study aimed to assess the efficacy of curcumin-piperine supplementation on clinical symptoms, duration, severity, and inflammatory factors in patients with COVID-19. METHODS: Forty-six outpatients with COVID-19 disease were randomly allocated to receive two capsules of curcumin-piperine; each capsule contained 500 mg curcumin plus 5 mg piperine or placebo for 14 days. RESULTS: Mean changes in complete blood count, liver enzymes, blood glucose levels, lipid parameters, kidney function, and c-reactive protein (CRP) were not significantly different between the two groups. There was a significant improvement in health status, including dry cough, sputum cough, ague, sore throat, weakness, muscular pain, headache, and dyspnea at week 2 in both curcumin-piperine and placebo groups (P value < 0.05); however, the improvement in weakness was more in the curcumin-piperine group than with placebo group (P value 025). CONCLUSION: The present study results showed that curcumin-piperine co-supplementation in outpatients with COVID-19 could significantly reduce weakness. However, in this study, curcumin-piperine co-supplementation could not significantly affect the other indices, including biochemical and clinical indices. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20121216011763N46 . 2020-10-31.

A systematic review and meta-analysis of preclinical and clinical studies on the efficacy of ginger for the treatment of fatty liver disease.

Fatty liver disease (FLD) is the most common chronic liver disease worldwide. The pathogenesis of this disease is closely related to obesity and insulin resistance. Ginger has hypolipidemic and antioxidant effects and acts as an insulin sensitizer. This study aims to evaluate the effect of ginger supplementation on the fatty liver. A comprehensive search of Medline/PubMed, Embase, Scopus, Web of Science/ISI, and Cochrane databases was conducted without time or language restrictions. Eighteen eligible studies were identified, including 17 in-vivo experiments in quantitative analysis and 3 clinical trials in qualitative analysis. The present study provides comprehensive evidence of the efficacy of ginger to improve the liver levels of cholesterol (-5.60 mg/g), triglycerides (TG, -4.28 mg/g), malondialdehyde (-3.16 nmol/mg), catalase (CAT) (3.35 nmol/mg), superoxide dismutase (SOD, 3.01 U/mg), serum levels of alanine aminotransferase (ALT, -2.85 U/L), aspartate aminotransferase (AST, -0.98 U/L), TG (-4.98 mg/dL), low-density lipoprotein (LDL, -3.94 mg/dL), total cholesterol (TC, -3.45 mg/dL), high-density lipoprotein (HDL, 1.27 mg/dL), and fasting blood sugar (FBS, -2.54 mg/dL). Ginger administration may reduce many clinical aspects of FLD by several mechanisms, including insulin-sensitive effects, stimulating the expression of antioxidant enzymes, reducing the generation of reactive oxygen species (ROS), having antidyslipidemic activities, and reducing hepatic fat content. However, future clinical trials are essential to investigate the clinical application of ginger in this area.

Arctigenin, an anti-tumor agent; a cutting-edge topic and up-to-the-minute approach in cancer treatment.

Today, herbal-derived compounds are being increasingly studied in cancer treatment. Over the past decade, Arctigenin has been introduced as a bioactive dibenzylbutyrolactone lignan which is found in Chinese herbal medicines. In addition to anti-microbial, anti-inflammatory, immune-modulatory functions, Arctigenin has attracted growing attention due to its anti-tumor capabilities. It has been shown that Arctigenin can induce apoptosis and necrosis and abolish drug resistance in tumor cells by inducing apoptotic signaling pathways, caspases, cell cycle arrest, and the modulating proteasome. Moreover, Arctigenin mediates other anti-tumor functions through several mechanisms. It has been demonstrated that Arctigenin can act as an anti-inflammatory compound to inhibit inflammation in the tumor microenvironment. It also downregulates factors involved in tumor metastasis and angiogenesis, such as matrix metalloproteinases, N-cadherin, TGF-ß, and VEGF. Additionally, Arctigenin, through modulation of MAPK signaling pathways and stress-related proteins, is able to abolish tumor cell growth in nutrient-deprived conditions. Due to the limited solubility of Arctigenin in water, it is suggested that modification of this compound through amino acid esterification can improve its pharmacogenetic properties. Collectively, it is hoped that using Arctigenin or its derivates might introduce new chemotherapeutic approaches in future treatment.

Effect of curcumin-pipeine supplementation on clinical status, mortality rate, oxidative stress, and inflammatory markers in critically ill ICU patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial.

OBJECTIVES: This study aims to investigate the efficacy of curcumin-piperine co-supplementation on oxidative stress factors, clinical symptoms, and mortality rate in patients with coronavirus (COVID-19) admitted to the intensive care unit (ICU). TRIAL DESIGN: This study is a randomized, placebo-controlled, double-blind, parallel-arm clinical trial. PARTICIPANTS: The study participants will be recruited from patients admitted to the ICU of Al-Zahra hospital with a definitive diagnosis of COVID-19. The inclusion criteria are aged between 20 and 75 years, confirmation of COVID-19 based on the PCR test, and admitted to the ICU. The exclusion criteria include the present use of parenteral nutrition support, a history of underlying diseases such as congenital disorders, immune diseases, renal and hepatic insufficiency, and pancreatitis, a history of sensitivity to herbal remedies such as turmeric and pepper, and regular use of anticoagulant drugs such as warfarin. This study will be performed in the Al-Zahra hospital, an academic hospital affiliated with Isfahan University of Medical Sciences, Isfahan, Iran. INTERVENTION AND COMPARATOR: Sixty eligible patients will be randomly assigned, in a 1:1 ratio, to receive curcumin-piperine capsules (three capsules/day; each capsules containing 500 mg curcumin plus 5 mg piperine; in total 1500 mg curcumin and 15 mg piperine/daily) for seven days (n=30) or matching placebo capsules (three capsules/day; each capsules containing 505 mg maltodextrin; totally 1515 mg, maltodextrin/ daily) for same duration (n=30). Capsules will be administered after oral or enteral feeding at 9, 15 and 21 o'clock. MAIN OUTCOMES: The primary outcome is the time from initiation of supplementation (curcumin-piperine or placebo) to normalization of fever, respiratory rate, and blood oxygen saturation. The secondary outcomes are the mortality rate, length of stay in ICU, temperature, levels of blood oxygen saturation, ventilator dependency, respiratory rate, levels of C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), levels of liver markers (ALT, AST, LDH), and levels of kidney function markers (BUN, Creatinine). FOLLOW UP: All of the parameters will be assessed at baseline and end of the study (7 days intervention). In addition, the rate of mortality will be collected after 4 weeks (28 days' mortality in the ICU, 4 weeks follow up). RANDOMISATION: Eligible patients will be randomly assigned to either the intervention group (Curcumin-piperine) or the control group (Placebo). Randomization sequences will be generated using an electronic table of random numbers to allocate the included participants into either control or intervention groups (in a 1:1 ratio) using the stratified block randomization method. Stratification was conducted according to sex (male and female), with a block size of four. The allocation sequences will be prepared by an independent statistician and will be kept inside sealed, opaque, and consecutively numbered envelopes. Participants, investigators, nurses, and physicians will be unaware of the trial-group assignment. BLINDING (MASKING): This study is a double-blind clinical trial (participants, investigators, nurses, and physicians). The curcumin-piperine and placebo supplements will be similar in the terms of texture, taste, color, odor, and weight. Both tablets will be provided in containers that are completely identical in weight, shape, labeling, and packaging. All participants, investigators, nurses, and physicians will be unaware of the trial-group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The sample size is estimated at 60 participants, including 30 patients in the intervention group and 30 patients in the placebo group. TRIAL STATUS: The protocol is Version 2, registered on May 13, 2021. Recruitment began May 20, 2021, and is anticipated to be completed by September 20, 2021. TRIAL REGISTRATION: This trial has been registered in Iranian Registry of Clinical Trials (IRCT) with the title of "Evaluation of the effect of curcumin-piperine supplementation in patients with coronavirus admitted to the intensive care unit (ICU): a double-blind clinical trial study". IRCT registration number is IRCT20121216011763N52 . The registration date was May 13, 2021. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (File 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

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.

The Use of Curcumin for the Treatment of Renal Disorders: A Systematic Review of Randomized Controlled Trials.

Chronic kidney disease (CKD) is one of the significant causes of morbidity and mortality worldwide, which could develop and progress to end-stage renal disease. Increased inflammation and reduced antioxidant capacity commonly occur in CKD and hemodialysis patients. Curcumin is a natural bioactive compound with antioxidant and anti-inflammatory properties. This systematic review was undertaken with the main aim of assessing the effects of curcumin/turmeric supplementation on renal diseases based on clinical trials. A comprehensive search was performed in PubMed/MEDLINE, Scopus, ISI Web of Science, and Google Scholar from inception up to April 6, 2020 to identify clinical trials assessing the effects of curcumin or turmeric alone, or in combination with other herbs or nutrients on renal diseases. Twelve studies met the eligibility criteria. These randomized controlled trials (RCTs) comprised 631 patients with either chronic kidney diseases (CKD), hemodialysis, diabetic proteinuria and nephropathy, and lupus nephritis. Curcumin/turmeric supplementation had favorable effects on renal diseases, particularly in terms of inflammation and oxidative stress. However, with the exception for proteinuria, their impact on clinical parameters, such as blood urea nitrogen, creatinine, glomerular filtration rate (GFR), and serum albumin, was weak and not significant. No serious adverse effects were reported following curcumin/turmeric supplementation. Within the limitations of this review, it can be concluded that curcumin/turmeric supplementation might have some beneficial effects on inflammatory and oxidative stress parameters of patients but no considerable positive impact on clinical outcomes of kidney diseases, apart from proteinuria.

Curcumin for the Treatment of Prostate Diseases: A Systematic Review of Controlled Clinical Trials.

Prostate cancer is one of the significant causes of morbidity and mortality worldwide. Benign prostatic hyperplasia is another condition of the prostate which, like prostate cancer, is more common among ageing men and is linked to inflammation. In this study, a systematic review was undertaken to estimate the effect of turmeric or curcumin supplementation on prostate diseases. A comprehensive search was conducted in PubMed, Scopus, ISI Web of Science and Google Scholar up to 15 April 2020 to identify clinical trials assessing the effects of curcumin/turmeric alone or in combination with other herbs on prostate diseases. This led to the identification of 11 records comprising 745 patients who met the eligibility criteria. Eight studies were conducted on patients with prostate cancer, and three were on other diseases of the prostate. Although outcomes across the studies were heterogeneous, in some studies curcumin/turmeric supplementation had some favourable effects. This included beneficial effects on the levels of prostate-specific antigen (PSA) (2/6 studies), quality of life (1/2 studies), as well as on oxidative stress markers, feelings of incomplete bladder emptying, urination frequency, intermittency, urgency, weak stream, straining and nocturia. Curcumin/turmeric supplementation had no significant adverse effects among patients. This study demonstrated that turmeric or curcumin supplementation might have beneficial effects on some parameters related to prostate diseases, but it should be noted that some studies showed no effect. Therefore, further studies using curcumin-related compounds, particularly in highly bioavailable forms, are needed to assess the impact of curcumin on prostate conditions.

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.

A systematic review of preclinical studies on the efficacy of propolis for the treatment of inflammatory bowel disease.

Propolis is a resinous substance produced by bees from plants. There has been some evidence indicating that propolis may be a candidate for the treatment of inflammatory bowel disease (IBD) because of its potent antioxidant properties and ability to modulate immune response and gut microbiome. The objective of this systematic review was to investigate the role of propolis in the treatment of IBD, emphasizing possible mechanisms underlying the anti-inflammatory properties of it. Searches were performed in ISI, PubMed/Medline, Scopus, EMBASE, and Cochrane Library databases up to March 2020. According to the studies examined in this review, the administration of propolis can be useful in attenuating many aspects of clinical, macroscopic, and histological features of colitis in animal models. The efficacy of propolis in the treatment of IBD might be attributed to its potent antioxidants and anti-inflammatory activities. Propolis may also be involved in the modulation of the gut microbiota and in the improvement of the intestinal mucosal barrier function. The major mechanism of action is most likely to be mediated via the prevention of some transcriptional factors and associated proteins. However, future studies are warranted to investigate the clinical utility of propolis as a candidate in the treatment of IBD.

Protective effects of propolis on hepatic steatosis and fibrosis among patients with nonalcoholic fatty liver disease (NAFLD) evaluated by real-time two-dimensional shear wave elastography: A randomized clinical trial.

Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease, while no drugs have been approved for its treatment. The pieces of evidence indicate that propolis as a novel anti-inflammatory agent might be a promising candidate to treat NAFLD. We aimed to evaluate the efficacy of propolis on hepatic steatosis and fibrosis in patients with NAFLD. This randomized clinical trial was conducted on 54 patients with NAFLD. Patients were randomly assigned to receive propolis tablets at a dose of 250 mg twice daily for 4 months or placebo. The improvement in hepatic steatosis and fibrosis was evaluated using two-dimensional shear wave elastography. Improvement in the hepatic steatosis was significantly higher in the propolis group than the placebo group, even after adjustment for baseline value and changes in weight, energy intake, and physical activity (odds ratio [OR]: 5.67; 95% confidence intervals [CI]: 1.41-22.8; p = .014). A significant reduction was observed on the liver stiffness in the propolis group (-0.65 ± 0.56 kPa; p = .001), whereas it increased in the placebo group (0.27 ± 0.59 kPa; p = .037). Also, the intake of propolis significantly decreased high-sensitivity C-reactive protein (hs-CRP) levels compared with the placebo group (-0.371; 95%CI: -0.582 to -0.16 mg/L; p = .01). Changes in serum levels of fasting blood sugar, alanine aminotransferase, aspartate aminotransferase, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, cholesterol, and triglyceride did not differ significantly between the two groups (p > .05). There was no significant improvement in insulin resistance in both groups (p > .05). Propolis seems to have protective effects on hepatic steatosis and fibrosis and to reduce the serum levels of hs-CRP in patients with NAFLD.

The effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19): A structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: This study aims to assess the effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19). TRIAL DESIGN: This is a Double-Blind, Placebo-Controlled, Parallel Arm, Randomized Phase ΙΙ Clinical Trial. PARTICIPANTS: Patients with the confirmed COVID-19 based on the PCR test are eligible to participate in the trial if they are 18 to 75 years of age and have no history of the current use of warfarin or propolis supplement and presence of sensitivity to bee products. Patients will be recruited from the Al-Zahra hospital in Isfahan city, Isfahan, Iran. INTERVENTION AND COMPARATOR: Participants (N=40) in the intervention group will receive an identical propolis tablet (containing 300 mg Iranian green propolis extract) three times a day for a period of 2 weeks. Participants (N=40) in the control group will receive an identical placebo tablet (containing 300 mg microcrystalline cellulose) three times a day for 2 weeks. All tablets are prepared by the Reyhan Naghsh Jahan Pharmaceutical Co., Isfahan, Iran. MAIN OUTCOMES: The main outcomes are changes in the coronavirus disease's clinical symptoms including duration and severity from baseline to the end of 2 weeks. RANDOMIZATION: Eligible patients will be randomly allocated in a 1:1 ratio to the intervention or control group. Randomization will be performed on the basis of permuted block sizes of 4 and will be stratified according to sex categories. Randomization sequences will be prepared by the trial's pharmacist with the use of random-number tables. BLINDING (MASKING): The trial-group assignment will be concealed from all participants, clinicians, and investigators throughout the trial. To ensure blinding, randomization sequences will be kept in identical, opaque, sealed, sequentially numbered envelopes. Only the trial's pharmacist has access to the randomization list. Also, the placebo tablet will be similar to the propolis tablet in terms of texture, taste, color, odor, and weight. Both tablets will be provided in containers that are completely identical in weight, shape, labelling, and packaging. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): The calculated total sample size is 80 patients, with 40 patients in each group. TRIAL STATUS: The protocol is Version 1.0, October 10, 2020. Recruitment began August 22, 2020, and is anticipated to be completed by March 21, 2021. TRIAL REGISTRATION: The name of the trial register: The effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial. IRCT registration number: IRCT20200802048267N1 . Date of trial registration: 20 October 2020, retrospectively registered. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Effects of curcumin-piperine co-supplementation on clinical signs, duration, severity, and inflammatory factors in patients with COVID-19: a structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: This study aims to investigate the efficacy of curcumin-piperine co-supplementation on disease duration, severity and clinical symptoms, and inflammatory mediators in patients with coronavirus (COVID-19). TRIAL DESIGN: This is a randomized, placebo-controlled, double-blind, parallel arm clinical trial. PARTICIPANTS: All patients aged 20-75 years with the diagnosis of Covid-19 based on the PCR test. The exclusion criteria will include an age less than 20 and more than 75 years, current use of warfarin or other anticoagulant drugs, and the presence of sensitivity to herbal products such as turmeric and pepper. This study will be conducted in academic hospitals affiliated to Isfahan University of Medical Sciences, Isfahan, Iran. INTERVENTION AND COMPARATOR: Fifty outpatients will be randomly allocated in a ratio of 1:1 to receive a capsule of curcumin-piperine containing 500 mg curcumin plus 5 mg piperine or matching placebo containing 505 mg maltodextrin twice a daily, after lunch and dinner, over a period of 2 weeks. Similarly, 50 inpatients who are admitted to hospital wards excluding intensive care unit (ICU) will be randomly assigned in a ratio of 1:1 to receive a capsule curcumin-piperine or matching placebo (provided by the Sami Labs company) twice a daily, after lunch and dinner, over a period of 2 weeks. MAIN OUTCOMES: The main outcomes of this study are the efficacy of curcumin-piperine on coronavirus disease's clinical symptoms, duration, severity, and inflammatory mediators after 2 weeks of curcumin-piperine co-supplementation. RANDOMISATION: Randomization sequences will be generated with the use of a random-number table with a permuted block design (block size of 4) and stratification according to the gender variable (male vs. female). These sequences will be prepared by an independent statistician and will be kept in opaque, sealed, numbered envelopes which will be opened only at the time of enrollment. The allocation ratio in intervention and control groups is 1:1. Researchers and all patients will be unaware of the study-group assignment until the completion of data analyses. BLINDING (MASKING): This study is a double-blind clinical trial (participant, researcher). The curcumin-piperine and placebo supplements are packaged in similar numbered drug containers, and the researcher and all patients will be unaware of the study assignment until the end of the study. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The calculated total sample size is 100 patients, with 25 patients in each group. TRIAL STATUS: The protocol is Version 2.0, May 24, 2020. Recruitment began May 4, 2020, and is anticipated to be completed by April 19, 2021. TRIAL REGISTRATION: This trial has been registered by the title of "Effect of curcumin-piperine co-supplementation on disease duration, severity and clinical signs, and inflammatory factors in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial study" in the Iranian Registry of Clinical Trials (IRCT) with code "IRCT20121216011763N46", https://www.irct.ir/trial/47529 . The registration date is May 4, 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Therapeutic Effects of Garlic on Hepatic Steatosis in Nonalcoholic Fatty Liver Disease Patients: A Randomized Clinical Trial.

BACKGROUND AND AIMS: Emerging evidence suggests that garlic (Allium sativum L.) and its bioactive components can mitigate hepatic steatosis by the modulation of hepatic lipid metabolism. We aimed to assess the efficacy of the garlic administration on hepatic steatosis in patients with NAFLD. PATIENTS AND METHODS: This clinical trial was conducted on adult patients with ultrasound-diagnosed NAFLD. Eligible participants were randomly assigned, with the use of the stratified blocked procedure, to receive 800 mg garlic or placebo for 15 weeks. The primary outcome was the improvement in the hepatic steatosis diagnosed by ultrasound technique after 15 weeks of intervention. RESULTS: A total of 110 patients underwent randomization, and 98 patients completed the trial. Twenty-four (51.1%) patients in the garlic group achieved improvement in the hepatic steatosis compared to eight (15.7%) patients in the placebo group with the relative risk of 5.6 (95% CI: 2.17 to 14.5; P=0.001), which remained significant after adjusting for baseline value of hepatic steatosis. There were significant reductions in weight and serum ALT, AST, FBS, Hb A1C, total cholesterol, LDL-cholesterol, and TG concentration with the garlic intake compared to placebo (P<0.05). The results were also significant after adjusting for weight change, energy intake, and physical activity. No serious adverse effects were observed with the garlic intake. CONCLUSION: The intake of garlic powder was accompanied by a significant improvement in the hepatic steatosis and comorbidity related to this condition among subjects with NAFLD.

High Dose Vitamin D Supplementation Is Associated With a Reduction in Depression Score Among Adolescent Girls: A Nine-Week Follow-Up Study.

Although vitamin D deficiency is known to be a risk factor for some psychological disorders, there have been few studies on the effects of vitamin D supplementation on their symptoms. Depression and aggression are common mental disorders and are associated with disability and disease burden. We aimed to evaluate the effectiveness of high-dose vitamin D supplementation on depression and aggression scores in adolescent girls. Nine hundred forty adolescent girls received vitamin D3 at a dose of 50,000 IU/week for 9 weeks. Anthropometric parameters and blood pressure were measured using standard protocols at the baseline and at the end of the study. Depression score was evaluated using the Beck Depression Inventory-II and aggression was evaluated using the Buss-Perry Aggression Questionnaire at baseline and at the end of the study. Comparison among the four categories of depression score (normal, mild, moderate, and severe) revealed no significant differences in demographic and anthropometric parameters at baseline. After 9 weeks of vitamin D supplementation, there was a significant reduction on mild, moderate, and severe depression score. However, vitamin D supplementation had no significant effect on aggression score. Our results suggest that supplementation with vitamin D may improve depressive symptoms among adolescent girls, as assessed by questionnaire, but not aggression score. Formal, larger, randomized controlled studies are required to confirm this effect on cases with different degrees of depression.