The Effects of Ginger ( Zingiber Officinale Roscoe) on Non-Alcoholic Fatty Liver Disease in Patients with Type 2 Diabetes Mellitus: A Randomized Double-Blinded Placebo-Controlled Clinical Trial

AbstractNonalcoholic fatty liver disease (NAFLD) is a prominent etiological factor for liver cirrhosis worldwide. It is frequently associated with obesity, diabetes, dyslipidemia, and hypertension. The objective of this study is to assess the efficacy and safety of ginger (Zingiber officinale Roscoe) supplementation in patients with type 2 diabetes mellitus (T2DM) who have NAFLD. In a two-arm, double-blind, placebo-controlled clinical trial, seventy-six patients diagnosed with both T2DM and NAFLD were randomly assigned to receive either ginger powder capsules (1000 mg, twice daily) or placebo capsules (administered in the same manner) for a period of three months. Anthropometric measurements, blood pressure readings, biochemical profiles, and imaging parameters were assessed before and after the intervention. Safety measures were also evaluated. In both the ginger and placebo groups, there was a significant reduction in mean body mass index (BMI), waist and hip circumferences, as well as liver transaminase levels. Moreover, significant improvements in mean systolic and diastolic blood pressures were observed in the ginger group (p = 0.02 and < 0.0001, respectively). Within the ginger group, there was a decrease in serum insulin levels and insulin resistance (HOMA-IR) (p = 0.002 and 0.004, respectively). Furthermore, the ginger group exhibited an improvement in serum HDL-cholesterol level (p = 0.01). However, there were no significant changes in the assessed inflammatory markers or the indices obtained from fibroscan imaging, including steatosis percent and controlled attenuation parameter. This study demonstrates that ginger supplementation can significantly improve mean systolic and diastolic blood pressures. However, it does not have a significant impact on inflammatory markers or fibroscan imaging indices. Nonetheless, the three-month use of ginger improves serum insulin level, insulin resistance (HOMA-IR), and HDL-cholesterol level compared to baseline values. Further investigations with longer durations and larger sample sizes are recommended.Keywords: GingerZingiber officinaleNonalcoholic fatty liver diseaseDiabetes mellitusTraditional Persian medicineHerbal medicine AcknowledgementsThis study was a part of a PhD thesis by Dr. Parissa Sadat Ghoreishi, which submitted to the School of Medicine (SUMS, Iran) for fulfillment of the requirements for the PhD degree in traditional Persian medicine. The authors thank Dr. N. Shokrpour for the linguistic editing of the manuscript.Disclosure statementNo potential conflict of interest was reported by the author(s).Additional informationFundingThis study was supported by a grant from SUMS [Grant No.95- 12817].Notes on contributorsParissa Sadat GhoreishiParissa Sadat Ghoreishi, MD, PhD in Traditional Iranian Medicine, Department of Traditional Persian Medicine, Shiraz University of Medical Sciences, Shiraz, Iran. Her skills and researches are in Medical Science, Traditional Medicine, Herbal Medicine, Complementary & Alternative Medicine, Acupuncture, Nutrition, Cupping, Traditional medical literatures in Arabic or Persian language. She has several publications in clinical trials in traditional medicine.Mesbah ShamsMesbah Shams, Internist and Endocrinologist, His academic degree is Professor of Internal Medicine and Endocrinology at Shiraz University of Medical Sciences (I.R. Iran). He teaches general internal medicine to students and residents, teaches endocrinology to fellowships. At present he is the Head of Endocrinology and Metabolism Research Center. The major focuses of his research are RCT's for evaluation of safety and efficacy of dietary supplements, Iranian traditional medications and herbal remedies that used for treatment of type 2 diabetes mellitus by general population.Majid NimrouziMajid Nimrouzi, is assistant professor and head of the research center for traditional medicine and history of medicine from 2020 and head of the department of Persian medicine from 2014 up to now at Shiraz University of Medical Sciences. In 1992, he graduated from Shiraz University of Medical Sciences with a medical doctor degree and in 2007 he graduated with an MPH degree from Tehran University of Medical Sciences. He received a PhD in traditional Persian medicine at Iran University of Medical Sciences in 2014 and started his career as a faculty member of Shiraz University of Medical Sciences at the same time. His primary focus is on health and prevention from the perspective of Persian medicine, with a particular emphasis on nutrition and GI illnesses.Articles: https://isid.research.ac.ir/Majid_Nimrouzihttp://www.scopus.com/authid/detail.url?authorId=55220134500.https://scholar.google.com/citations?user=n67wX8MAAAAJ&hl=en&oi=ao.http://orcid.org/0000-0003-4630-2082.https://www.researchgate.net/profile/Majid_Nimrouzi.https://www.webofscience.com/wos/author/record/L-6127-2013.Mohammad M. ZarshenasMohammad Mehdi Zarshenas, Associated Professor of department of Phytopharmaceuticals (Traditional Pharmacy), School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran. Doctorate in Pharmacy (Pharm.D) and PhD in Traditional Pharmacy, School of Pharmacy, Shiraz University of Medical Science, Shiraz, Iran. Relevant course work: Modern Galenic Formulation; Galenic formulations for Traditional Pharmacy; Quality control for natural products; Phytotherapy; Botany; History of Medicine and Pharmacy; His studies and researches are in Traditional/ Historical Persian medical and Pharmaceutical manuscripts. He has authored more than 180 scientific publications. His laboratory skills and literature studies: Analytical Techniques: GC-MS, GC-FID, TLC, PLC, Column chromatography, HPTLC, HPCCC, UV, Microplate assay, Bioautographic TLC assay. Pharmaceutical and Pharmacognosy Techniques: Galenic formulations of traditional and modern pharmaceuticals including preparation of tablets, capsules, creams, syrups and suppositories, Different antimicrobial tests, Different methods of extraction. Ethnopharmacological study: Study of Iranian endemic plants specially those related to Fars province, expertise in collection of medicinal plants in related fields. Clinical Trial: Design, sampling and conducting of a clinical trial. Synthesis of chemicals: Synthesis of steroid derivatives. Literature study: Traditional medical and pharmaceutical literatures in Arabic or Persian language.Kamran Bagheri LankaraniKamran Bagheri Lankarani, He is full professor of internal medicine at Shiraz University of Medical Sciences (SUMS) and a senior member of Gastroenterology and Hepatology Research Center at SUMS, chairman of Health Policy Research Center and a senior staff member of liver transplant ward at SUMS. He got his M.D. Deploma, residency of internal medicine and subspecialty board on Gastroenterology and hepatology from Shiraz University of Medical Sciences (SUMS), Shiraz, Islamic Republic of Iran. He joined internal medicine department in SUMS on 1992 as an assistant professor. He served as director general of Nemazi hospital in Shiraz, vice chancellor of SUMS and as the chairman of internal medicine department and finally as the minister of health and medical education until September 2009. Currently He is also a member of several national and international professional societies. He has published over 400 papers in different fields of gastroenterology and hepatology including viral hepatitis. He also has co-authored in 5 books in this field. He is the editor-in-chief of Shiraz Electronic Medical Journal and Annals of colorectal research. He is also the chairman of hepatitis monthly editorial board and an editorial board member and reviewer of several other national and international journals.Ebrahim Fallahzadeh AbarghooeiEbrahim Fallahzadeh Abarghooei, M.D., Subspecialty Board of Internal Medicine, Gastroenterology and Hepatology Assistant Professor of Internal medicine and Gastroenterology department of Shiraz University of Medical Sciences. His studies and researches are in Gastroenterology. Professional Membership: Iranian National Medical Council, Iranian National Gastroenterology and Hepatology Society.Mozaffar TalebzadehMozaffar Talebzadeh, He completed clinical and internship courses, residency program (Internal Medicine) and fellowship program (Gastroenterology & Hepatology) at Shiraz University of Medical Sciences, Shiraz, Iran. He was in the top 3% among students in national Board exam of Internal medicine in 2009 and the first degree in national Board exam of fellowship program (Gastroenterology & Hepatology) in 2012 with the first attempt. His research and studies are in hepatitis and gastroenterology and has scientific publications and book in nutrition and health in gastrointestinal diseases. His memberships: Iranian College of Internal Medicine, Iranian Association of Gastroenterology and Hepatology (IAGH).Mohammad Hashem HashempurMohammad Hashem Hashempur, He graduated with an MD degree from Shiraz University of Medical Sciences (SUMS) and subsequently obtained a PhD in traditional Persian medicine (TPM). He has authored over 60 papers and 5 academic books, primarily focusing on TPM. His research interests primarily revolve around pain management, diabetes, and epidemiological studies on the use (and its associated factors) of complementary and alternative medicine by different populations. He has made editorial contributions to several journals, including Frontiers in Nutrition, Evidence-Based Complementary and Alternative Medicine, and Traditional and Integrative Medicine. Additionally, he has served as a reviewer for numerous international journals, contributing to the quality and credibility of published research.Currently, Dr. Hashempur holds the position of Vice-Chancellor for Research and Technology at SUMS. Previously, he served as the head of the University's Educational Development Center and Vice-Chancellor for traditional medicine. His active involvement in various national and international professional societies underscores his dedication to advancing and integrating TPM.For more information about Dr. Hashempur's academic profile, including his publications and citations, please visit his Scopus profile here: https://www.scopus.com/authid/detail.uri?authorId=55498239300