Study design
non-alcoholic fatty liver disease, NAFLD, hepatitis or alcoholic liver disease, cancer, liver fibrosis, hepatotoxic, human immunodeficiency virus (HIV) infection, liver or kidney failure, liver diseases, hypersensitivity, weight loss, steatosis
MORBID OBESITY, AUTOIMMUNE DISORDERS, CANCER, LIVER FIBROSIS, NON-ALCOHOLIC FATTY LIVER DISEASE, IMMUNE DISORDER, FOOD ALLERGIES, OXIDATIVE STRESS, LIVER DISEASES, HYPERSENSITIVITY, STEATOSIS
The present study constitutes a randomized, double-blind, controlled clinical trial aimed to examine the impact of pomegranate peel extract, administered as a dietary supplement over an eight-week duration, on various parameters including inflammatory and oxidative stress markers, nutritional status, and liver fibrosis and steatosis in individuals diagnosed with non-alcoholic fatty liver disease (NAFLD). The study was conducted in Mashhad, Iran, spanning from December 2021 to November 2022, and adhered to the ethical guidelines set forth in the Helsinki Declaration. Approval for the study was obtained from the ethics committee of Mashhad University of Medical Sciences (ethics code: IR.MUMS.MEDICAL.REC.1400.195 and IRCT20210726051988N1).The study had two phases; first, the extraction of pomegranate peel (PP) hydro-alcoholic extract; second, the randomized clinical trial. The study participants were selected from patients with NAFLD who sought medical attention at the Nutrition Clinic and fulfilled specific inclusion criteria. These criteria encompassed individuals between the ages of 18 and 60 years, diagnosed with liver fibrosis and steatosis through elastography or liver fibro scan, possessing the ability to read and write, and providing informed consent by completing the requisite form. Conversely, individuals were excluded from participation if they were pregnant or lactating, exhibited morbid obesity (with a body mass index exceeding 40), had a history of alcohol consumption surpassing 20 g per day for women or 30 g per day for men, suffered from any immune disorder, including autoimmune disorders, cancer, or human immunodeficiency virus (HIV) infection, experienced liver or kidney failure, presented with other liver diseases such as hepatitis or alcoholic liver disease, utilized hepatotoxic drugs such as sodium valproate, possessed a history of food allergies to pomegranate or herbal supplements, or had undergone bariatric surgery for weight loss.Throughout the study, participants who voluntarily withdrew from the research, became pregnant, developed hypersensitivity to either the pomegranate peel extract or the placebo, or exhibited less than 70% compliance with their assigned treatment regimen were excluded from further analysis.At the study’s initiation, all participants provided written informed consent. Demographic and socio-economic information, including education level, family size, housing status, occupation, medical history, and medication and supplement usage, was collected through a questionnaire. The sample size calculation for each group was based on Soleimani et al.‘s research on non-alcoholic fatty liver disease (NAFLD) [To minimize heterogeneity among the study groups, a blocked randomization design was implemented to allocate participants randomly. The blinding principles were strictly adhered to, ensuring that both the drug and placebo were indistinguishable in terms of color, size, smell, and packaging. This maintained blinding throughout the study and statistical analysis, with only the pharmacist possessing knowledge of the allocation. To conceal the random allocation, coded boxes were utilized. This ensured that neither the participants nor the researchers were aware of the group assignments until the conclusion of the study.Demographic and socio-economic information about the individuals was obtained using a specific questionnaire at beginning the study. The questionnaire included questions about education level, family size, housing status, occupation, medical history, and use of medications and supplements.