Publications by authors named "Davood Soleimani"

21 Publications

  • Page 1 of 1

Curcumin and Piperine in COVID-19: A Promising Duo to the Rescue?

Adv Exp Med Biol 2021 ;1327:197-204

Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.

COVID-19 is now pandemic throughout the world, and scientists are searching for effective therapies to prevent or treat the disease. The combination of curcumin and piperine is a potential option for the management of COVID-19 based on several mechanisms including antiviral, anti-inflammatory, immunomodulatory, antifibrotic, and antioxidant effects. Here, we describe the probable mechanism of curcumin-piperine against COVID-19. Administration of curcumin-piperine combination appears as a potential strategy to counterbalance the pathophysiological features of COVID-19 including inflammation. The optimal dose and duration of curcumin-piperine supplementation should be determined in the future.
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http://dx.doi.org/10.1007/978-3-030-71697-4_16DOI Listing
July 2021

Cinnamon: A Promising Natural Product Against COVID-19.

Adv Exp Med Biol 2021 ;1327:191-195

Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.

COVID-19 is a pandemic and acute respiratory disease. Every day, all around the world, researchers are endeavoring to find effective or potential adjuvant therapies. Studies illustrate that essential oils from cinnamon and derivatives such as cinnamaldehyde and cinnamic acid possess numerous biological activities. In this paper, we have reviewed the possible mechanisms of cinnamon on the inflammatory cascade as a potential alternative therapy to decrease oxidative stress and inflammation in COVID-19 patients.
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http://dx.doi.org/10.1007/978-3-030-71697-4_15DOI Listing
July 2021

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

Food Sci Nutr 2021 Jul 8;9(7):3631-3640. Epub 2021 May 8.

Department of Health, Science and Research Branch AJA University of Medical Sciences Tehran Iran.

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 VO 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.
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http://dx.doi.org/10.1002/fsn3.2319DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8269685PMC
July 2021

Effect of garlic powder supplementation on blood pressure and hs-C-reactive protein among nonalcoholic fatty liver disease patients: A randomized, double-blind, placebo-controlled trial.

Food Sci Nutr 2021 Jul 6;9(7):3556-3562. Epub 2021 May 6.

Department of Clinical Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences Isfahan Iran.

Based on the anti-inflammatory and antihypertensive properties of garlic, the current study was designed to evaluate the garlic powder effects on blood pressure and high-sensitivity C-reactive protein (hs-CRP) among Nonalcoholic Fatty Liver Disease patients (NAFLD). This randomized, double-blind, placebo-controlled trial study was conducted on 110 patients with NAFLD. The patients were randomly divided into 2 groups, receiving two tablets of either 400 mg garlic or placebo daily for 15 weeks. At baseline and the end of the study, blood pressure and hs-CRP were determined. Of 110 patients enrolled in the trial, 98 subjects were included in the final analysis. After the intervention, systolic blood pressures (SBP) (mean: -7.89; 95%CI:‒11.39 to -4.39 mm Hg), diastolic blood pressure (DBP) (mean: -5.38; 95%CI: -7.77 to -3 mm Hg), and Mean Arterial Pressure (MAP) (mean: -6:95%CI: -8.4 to -3.6 mm Hg) decreased significantly in the garlic group as compared to the placebo group. Also, the percentage of reduced hs-CRP was significantly higher in the intervention group compared with the control group (mean: -16.1; 95%CI: -32.7 to -0.53;  = .035). Moreover, a positive correlation was observed between the percentage change in hs-CRP and percentage changes in SBP ( = 0.221;  = .029), DBP ( = 0.166;  = .012), and MAP ( = 0.210;  = .038). Garlic supplementation can be a safe and potentially adjunct treatment to reduce blood pressure and the risk of cardiovascular disorders in patients with NAFLD.
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http://dx.doi.org/10.1002/fsn3.2307DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8269577PMC
July 2021

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

Food Sci Nutr 2021 Jul 6;9(7):3512-3520. Epub 2021 May 6.

Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences Isfahan Iran.

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 β-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), β-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; -value: 0.01; TNF-α: 0.12 ± 0.04 versus 0.62 ± 0.04 pg/ml; -value: 0.03). No significant changes were observed in VO max in both groups.

Conclusions: Our results showed that the combination of β-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.
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http://dx.doi.org/10.1002/fsn3.2297DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8269545PMC
July 2021

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.

Trials 2021 Jul 6;22(1):434. Epub 2021 Jul 6.

Food Security Research Center, Isfahan University of Medical Sciences, PO Box: 00983117922110, Isfahan, Iran.

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.
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http://dx.doi.org/10.1186/s13063-021-05372-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8258487PMC
July 2021

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

Phytother Res 2021 Jun 17. Epub 2021 Jun 17.

Department of Community Nutrition, School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.

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.
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http://dx.doi.org/10.1002/ptr.6990DOI Listing
June 2021

Curcumin and cancer; are long non-coding RNAs missing link?

Prog Biophys Mol Biol 2021 Apr 21. Epub 2021 Apr 21.

Noncommunicable Diseases Research Center, Bam University of Medical Sciences, Bam, Iran. Electronic address:

Despite significant signs of progress in cancer treatment over the past decade, either cancer prevalence or mortality continuously grow worldwide. Current anti-cancer agents show insignificant effectiveness, followed by serious side effects. It is important to find new, highly efficient pharmacological agents to increase cancer patients' clinical outcomes. Curcumin, a polyphenolic compound, has gained growing attention because of its anti-cancer properties. Curcumin can hinder the development, migration, and metastasis of cancer cells. The anti-cancer effects of curcumin are principally attributed to the regulation of several cellular signaling pathways, including MAPK/PI3K/Akt, Wnt/β-catenin, JAK/STAT, and NF-ĸB signaling pathways. Furthermore, curcumin can affect the expression and function of tumor-suppressive and oncogenic long non-coding RNAs (lncRNAs). In this study, we briefly reviewed the modulatory effect of curcumin on dysregulated tumor-supportive and tumor-suppressive lncRNAs in several cancers. It is hoped that a better understanding of curcumin's anti-cancer properties would pave the way for the development of a therapeutic approach in cancer.
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http://dx.doi.org/10.1016/j.pbiomolbio.2021.04.001DOI Listing
April 2021

Dietary inflammatory index and healthy eating index-2015 are associated with rheumatoid arthritis.

Public Health Nutr 2021 Mar 16:1-21. Epub 2021 Mar 16.

Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

Objective: Many arthritic patients have the belief that dietary habits can worsen or ameliorate their symptoms. Whether diet quality can modify the risk of rheumatoid arthritis (RA) is an issue of continued scientific debate and interest. Therefore, we aimed to examine the association between both overall diet quality and the overall diet inflammatory potential on the risk of RA.

Design: Overall diet quality and the overall inflammatory potential of the diet were evaluated with the use of Dietary Inflammatory Index (DII) and the Healthy Eating Index (HEI)-2015, respectively. Both DII and HEI-2015 scores were calculated based on a validated semi-quantitative Food Frequency Questionnaire (FFQ). Multivariable-adjusted odds of RA were calculated across tertiles of HEI, and Energy-adjusted DII (E-DII) scores using binary logistic regression.

Setting: Mashhad, Iran.

Participants: 50 newly diagnosed RA cases and 100 well-matched healthy people controls.

Results: Individuals in the highest tertile of DII scores, indicating the most pro-inflammatory diet, were about three times more likely to have RA than those in the lowest tertile (Odds Ratio: 2.99; 95%CI: 1.08 to 8.24; P-trend:0.037), whereas individuals in the highest tertile of HEI scores, indicating more top dietary quality, had a significantly lower odds of RA than those in the lowest tertile (Odds Ratio: 0.33; 95%CI: 0.12 to 0.87; P-trend:0.024).

Conclusion: Our findings show that E-DII and HEI-2015 are positively and negatively associated, respectively, with the odds of RA in a convenience sample of Iranians. These results highlight the importance of overall diet quality in modulating the risk of RA.
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http://dx.doi.org/10.1017/S1368980021001105DOI Listing
March 2021

A comprehensive review of long non-coding RNAs in the pathogenesis and development of non-alcoholic fatty liver disease.

Nutr Metab (Lond) 2021 Feb 23;18(1):22. Epub 2021 Feb 23.

Noncommunicable Diseases Research Center, Bam University of Medical Sciences, Bam, Iran.

One of the most prevalent diseases worldwide without a fully-known mechanism is non-alcoholic fatty liver disease (NAFLD). Recently, long non-coding RNAs (lncRNAs) have emerged as significant regulatory molecules. These RNAs have been claimed by bioinformatic research that is involved in biologic processes, including cell cycle, transcription factor regulation, fatty acids metabolism, and-so-forth. There is a body of evidence that lncRNAs have a pivotal role in triglyceride, cholesterol, and lipoprotein metabolism. Moreover, lncRNAs by up- or down-regulation of the downstream molecules in fatty acid metabolism may determine the fatty acid deposition in the liver. Therefore, lncRNAs have attracted considerable interest in NAFLD pathology and research. In this review, we provide all of the lncRNAs and their possible mechanisms which have been introduced up to now. It is hoped that this study would provide deep insight into the role of lncRNAs in NAFLD to recognize the better molecular targets for therapy.
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http://dx.doi.org/10.1186/s12986-021-00552-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7903707PMC
February 2021

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.

Trials 2020 Dec 17;21(1):1027. Epub 2020 Dec 17.

Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.

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.
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http://dx.doi.org/10.1186/s13063-020-04924-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745196PMC
December 2020

Major dietary patterns and food groups in relation to rheumatoid arthritis in newly diagnosed patients.

Food Sci Nutr 2020 Dec 12;8(12):6477-6486. Epub 2020 Oct 12.

Department of Nutrition Faculty of Medicine Mashhad University of Medical Sciences Mashhad Iran.

Background: Evidence suggests that dietary patterns might act as environmental triggers in the development of chronic disorders such as rheumatoid arthritis (RA). However, data regarding the relationship between food patterns and RA are still limited and conflicting. In the current study, the authors aim to evaluate a link between major dietary patterns and RA in new case patients.

Methods: This study was conducted in a case-control manner on 50 patients with newly diagnosed RA and 100 healthy individuals living in Mashhad, Iran. The individuals' dietary intake was assessed using a validated food frequency questionnaire (FFQ). The major dietary patterns were identified using factor analysis based on data from FFQ. Multivariable-adjusted logistic regression models were used to measure the associations between patterns and RA.

Results: Three major dietary patterns were identified. High-level adherence to Western pattern had a positive association with RA (multivariable-adjusted OR tertile 3 vs. 1:1.95; 95% CI: 1.09-3.92; -trend: .046), while the healthy pattern was inversely related to RA (multivariable-adjusted OR tertile 3 vs. 1:0.12; 95% CI: 0.03-0.44; -trend: .001). No significant association was observed between the traditional pattern and RA.

Conclusions: Our findings revealed that people with dietary behaviors close to the Western dietary pattern are more likely to develop the disease. However, adhering to healthy and well-balanced dietary patterns rich in whole grains, low-fat dairies, white meats, eggs, fruits, vegetables, tea, and vegetable oils was found to be inversely correlated with the risk of RA.
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http://dx.doi.org/10.1002/fsn3.1938DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7723202PMC
December 2020

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.

Trials 2020 Dec 3;21(1):996. Epub 2020 Dec 3.

Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.

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.
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http://dx.doi.org/10.1186/s13063-020-04934-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7713667PMC
December 2020

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.

Phytother Res 2021 Mar 9;35(3):1669-1679. Epub 2020 Nov 9.

Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

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.
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http://dx.doi.org/10.1002/ptr.6937DOI Listing
March 2021

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

Phytother Res 2021 Feb 29;35(2):701-710. Epub 2020 Sep 29.

Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.

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.
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http://dx.doi.org/10.1002/ptr.6856DOI Listing
February 2021

Does propolis affect the quality of life and complications in subjects with irritable bowel syndrome (diagnosed with Rome IV criteria)? A study protocol of the randomized, double-blinded, placebo-controlled clinical trial.

Trials 2020 Aug 5;21(1):698. Epub 2020 Aug 5.

Nutrition Research Center, Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.

Background: Irritable bowel syndrome (IBS) is one of the most frequent and recurrent gastrointestinal diseases. However, up to now, no pharmacological agent has been approved to treat IBS. Emerging evidence showed that inflammation has a vital role in enhancing nervous system sensitivity and perception of abdominal pain in subjects with IBS. Propolis is an herbal substance with a broad spectrum of antioxidants, anti-inflammatory, and prebiotic properties, which might exert beneficial effects to reduce the severity of IBS. The current clinical trial aims to evaluate the efficacy of propolis supplementation on IBS.

Methods: This single-center, randomized, double-blind, placebo-controlled clinical trial will be performed to evaluate the effect of propolis supplementation in adult patients with IBS diagnosed with Rome IV criteria. Fifty-two eligible patients will randomly be allocated to receive a propolis tablet (450 mg, containing 100 mg polyphenol compounds) or identical placebo, twice daily for 6 weeks. The primary outcome of the trial is an improvement in IBS severity from baseline to the sixth week of intervention. The secondary outcomes include the change in weight, waist circumference, and IBS quality of life. We will use the paired sample t test or Mann-Whitney U test for the within-group comparison and independent sample t test or Wilcoxon rank-sum and chi-square test or Fisher's exact test for the between-group comparison. Besides, a multivariable-adjusted mean effect will be computed using the ANCOVA test.

Discussion: We hypothesize that propolis supplementation would be useful for treating IBS through its antioxidants, anti-inflammatory, and prebiotic properties. This trial will show the results of propolis supplementation, whether positive or negative, on IBS. If the current trial confirms our hypothesis, propolis supplementation can be a new choice in adjunctive therapy of IBS.

Trial Registration: Iranian Registry of Clinical Trials IRCT20190708044154N1. Registered on 26 December 2019. Updated on 13 February 2020. https://en.irct.ir/trial/40983 SPONSOR: Tabriz University of Medical Sciences, Tabriz, Iran.
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http://dx.doi.org/10.1186/s13063-020-04615-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7405434PMC
August 2020

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

Diabetes Metab Syndr Obes 2020 7;13:2389-2397. Epub 2020 Jul 7.

Department of Community Nutrition, School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.

Background And Aims: Emerging evidence suggests that garlic ( 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.
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http://dx.doi.org/10.2147/DMSO.S254555DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7354004PMC
July 2020

Depression Relationship with Dietary Patterns and Dietary Inflammatory Index in Women: Result from Ravansar Cohort Study.

Neuropsychiatr Dis Treat 2020 29;16:1595-1603. Epub 2020 Jun 29.

Research Center for Environmental Determinants of Health (RCEDH), Kermanshah University of Medical Sciences, Kermanshah, Iran.

Background And Aims: Chronic inflammation is thought to have a major role in the pathophysiology of depression. Diet has been shown to modulate the inflammatory state, thus emphasizing its potential as a therapeutic role in depression. But, little is known about the relationship between dietary intake and depression. The current study aimed to investigate the relationship between major dietary patterns, a dietary inflammatory index (DII) score, and depression among women.

Methods And Materials: This cross-sectional study included 4630 women aged 35-65 years using baseline data from the Ravansar Non-Communicable Diseases (RaNCD) cohort study in Western Iran. Diet was evaluated using a validated 125-item food frequency questionnaire (FFQ) to determine DII scores and dietary patterns. Traditional, healthy, and unhealthy dietary patterns were extracted using factor analyses.

Results: A significant upward trend in the odds of depression was observed across the tertiles s of DII scores (P-trend: 0.019). After the adjustment for possible risk factors, a high adherence to an unhealthy dietary pattern was associated with a higher risk of depression than a low adherence (OR: 1.63; 95% CI: 1.1-2.4). A high adherence to a healthy dietary pattern was associated with the lower odds (OR: 0.61; 95% CI: 0.04-0.92). Among the main food groups, a high intake of eggs and refined grains was associated with a higher risk of depression.

Conclusion: In women, a refined grain dietary pattern is a risk factor for depression, whereas a healthy dietary pattern is protective. We have also shown that adherence to a pro-inflammatory diet was significantly associated with depression. Adherence to a dietary pattern with high intakes of dairy products, seafood, red meats, nuts, vegetables, fruits, flavor, and vegetable oils and diets with low inflammatory properties were associated with a lower risk of depression in women.
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http://dx.doi.org/10.2147/NDT.S255912DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7334035PMC
June 2020

Dietary patterns in relation to hepatic fibrosis among patients with nonalcoholic fatty liver disease.

Diabetes Metab Syndr Obes 2019 12;12:315-324. Epub 2019 Mar 12.

Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran,

Background: Nonalcoholic fatty liver disease (NAFLD) is a multifactorial disorder that can progress to fibrosis. Several dietary patterns have been associated with histological features of NAFLD. However, little is known about the association between dietary patterns and hepatic fibrosis.

Purpose: The current study aimed at identifying the relationship between major dietary patterns and hepatic fibrosis among patients with NAFLD.

Subjects And Methods: This cross-sectional study included 170 eligible subjects with NAFLD. Diet was evaluated using three 3-day dietary records during a 1-month period. Hepatic fibrosis was diagnosed using Fibroscan. Western, Iranian, and healthy dietary patterns were extracted using factor analysis.

Results: After adjustment for other risk factors, adherence to a Western dietary pattern was associated with the higher odds of fibrosis (OR: 4.21; 95% CI: 1.63-8.31), whereas adherence to a healthy dietary pattern was associated with the lower odds of fibrosis (OR: 0.26; 95% CI: 0.10-0.49). Among main food groups, high intake of red meat, hydrogenated fats, and soft drinks was associated with the higher risk of fibrosis, whereas tea and coffee consumption had a protective role in hepatic fibrosis independent of other risk factors.

Conclusion: The adherence to a healthy dietary pattern characterized by high intake of low-fat dairies, white meat, nuts, vegetables, fruits, and vegetable oils combined with coffee and tea consumption might be helpful in the nutritional strategies against hepatic fibrosis.
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http://dx.doi.org/10.2147/DMSO.S198744DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6420105PMC
March 2019

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

J Diet Suppl 2018 Mar 31;15(2):173-182. Epub 2017 Jul 31.

i Metabolic Syndrome Research Center , Mashhad University of Medical Sciences , Mashhad , Iran.

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 D 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.
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http://dx.doi.org/10.1080/19390211.2017.1334736DOI Listing
March 2018

Effect of garlic powder consumption on body composition in patients with nonalcoholic fatty liver disease: A randomized, double-blind, placebo-controlled trial.

Adv Biomed Res 2016 27;5. Epub 2016 Jan 27.

Department of Epidemiology and Biostatistics, Faculty of Health, Isfahan University of Medical Sciences, Isfahan, Iran.

Background: Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease that is becoming a public health problem in recent decades. Obesity and overweight play a key role in NAFLD pathogenesis. Thus, weight loss (especially body fat mass) is one component of therapeutic strategies in NAFLD. Results from experimental studies have shown that garlic (Allium sativum L.) can reduce body weight and body fat mass. However, the effect of garlic on body fat mass and weight in the human population, which is addressed in this study, is still obscure.

Materials And Methods: In this clinical trial, 110 subjects with NAFLD were randomly assigned to the intervention or the control group. The intervention group received two garlic tablets (containing 400 mg of garlic powder) daily while the control group received placebo tablets. Dietary intake and physical activity of participants were obtained by a validated questionnaire. Body composition was measured by bioelectrical impedance analysis. Data were analyzed using SPSS software version 16.

Results: In the intervention group, significant reductions were observed in body weight and body fat mass (P < 0.05). We also observed a significant reduction in body weight in the control group, but there were no significant changes in total body water and lean body mass in both groups (P > 0.05). In the intervention group, the percentage change in body weight was significantly greater than the control group (-2.6 vs. -0.7, P = 0.02). No serious side effects associated with the intervention were reported.

Conclusion: Our trial suggests that garlic supplemfrom experimental studies have shown thatentation can reduce body weight and fat mass among subjects with NAFLD.
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http://dx.doi.org/10.4103/2277-9175.174962DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4763563PMC
March 2016