]>
IRCT20240901062927N1 IRCT 2024-09-09 Shiraz University of Medical Sciences Effects of a Low Acid Load Diet and NAC Supplementation on Hepatic Steatosis and Metabolic Factors in NAFLD Patients Investigating the Effects of a Low Acid Load Diet and N-Acetylcysteine Supplementation on Hepatic Steatosis, Biochemical, Anthropometric, and Blood Pressure Indices in Patients with Non-Alcoholic Fatty Liver Disease 2024-10-05 anticipated 66 Complete https://irct.ir/trial/78806 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To ensure the integrity of the study, participants will be divided into three groups: two intervention groups and one control group. This division will be achieved using Stratified permuted block randomization , based on two levels of hepatic steatosis severity (moderate and severe), as determined by the CAP score obtained from FibroScan results. The allocation will utilize a reliable online tool for randomization, accessible at: https://www.sealedenvelope.com/simple-randomiser/v1/lists Once the random allocation sequence is established, the groups will be labeled with conventional names: A, B, and C. These names will be placed in sealed envelopes according to the predetermined sequence, which will be numbered sequentially. After participants enter the study and complete their initial assessments, a sealed envelope corresponding to their order of entry will be opened. This envelope will contain the assigned group's conventional name, which was determined by an external party not involved in the study. This method ensures that the allocation sequence remains concealed from the research team, maintaining the blinding necessary for unbiased implementation, Blinding description: In this study, two main interventions, one in the form of diet and the other in the form of supplements, are presented to the patients. Since designing and presenting the diet and teaching it to the patient is the responsibility of the principal investigator , and it is not possible to blind the trainer, the present intervention will be performed in a single blind manner. At the outset of the study, the principal investigator will coordinate with participants, oversee the study's implementation, and gather baseline data. Throughout the intervention, the principal investigator will engage in various activities, including making phone calls, monitoring diet and physical activity, sending text messages, and conducting face-to-face meetings with participants. Following the completion of the intervention, the principal investigator will also assess anthropometric indicators. Finally, the principal investigator will be responsible for the final data collection, statistical analysis, and preparation of the final report. N/A Non alcoholic fatty liver disease (NAFLD). Intervention 1: Intervention group 1 : 1200 mg N-acetylcysteine (two tablets) daily + healthy diet. Intervention 2: Intervention group 2 : Low acid load diet + two starch tablets daily. Intervention 3: Control group: Healthy diet + two starch tablets daily. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not yet known if there will be a plan to make this available
public Shiraz University of Medical Sciences
Yaqtin St, Amirkabir Blvd
Shiraz Iran (Islamic Republic of) 7176857393 +98 71 3832 2402 bashiriisara@gmail.com Shiraz University of Medical Sciences scientific Afsane Ahmadi
Razi Blvd
Shiraz Iran (Islamic Republic of) 7134814336 0098 7137251001-8 ahmadi.afsane@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Literate individuals diagnosed with NAFLD, exhibiting moderate to severe steatosis based on gastroenterology and liver specialist evaluations, with a CAP score of ≥260 dB/m obtained from a fibroscan Absence of pregnancy, breastfeeding, other liver diseases, hepatic encephalopathy, malignancies, diabetes mellitus, kidney disorders and mental health issues Fibroscan should have been conducted within the last three weeks Participants must have a body mass index between 25 and 35 (25≤BMI≤35) and a liver stiffness measurement (LSM) of ≤9.4 kPa Individuals who drink little or no alcohol (defined as < 20 g/d for women and < 30 g/d for men) No history of hormonal medication or weight-affecting drugs within the past three months, nor previous bariatric surgery or current antioxidant supplementation Individuals on fixed treatments for dyslipidemia or hypertension, with no history of infection, surgery, trauma, or hospitalization in the last two weeks 18 years 60 years Both Individuals who become pregnant during the study or fail to return for follow-up assessments Participants demonstrating less than 70% adherence to diet or less than 80% adherence to supplement intake Occurrence of gastrointestinal side effects related to supplement use K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Treatment - Other Placebo Intervention group 1 : 1200 mg N-acetylcysteine (two tablets) daily + healthy diet. Intervention group 2 : Low acid load diet + two starch tablets daily Control group: Healthy diet + two starch tablets daily Levels of liver enzymes (AST , ALT). Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Using a special kit and an autoanalyzer device. Serum glutathione. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Using a special kit and an autoanalyzer device. Fasting blood sugar. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Using a special kit and an autoanalyzer device. Fasting insulin. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Using ELIZA kits and a ELIZA reader device. Lipid profile (HDL, LDL, Total cholesterol, Triglycerides). Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Using a special kit and an autoanalyzer device. Liver stiffness measurement (LSM). Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Vibration-controlled transient elastography (fibroscan). Insulin resistance indices (HOMA-IR & QUICKI). Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Using special formulas containing fasting blood sugar and insulin. Blood pressure. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Using a sphygmomanometer. Anthropometric indices. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Using meter, body analyzer device and special formulas. Controlled attenuation parameter (CAP) score. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Vibration-controlled transient elastography (fibroscan). Shiraz University of Medical Sciences Approved 2024-08-04 Ethics Committee of Shiraz University of Medical Sciences Central building of Shiraz University of Medical Sciences, Zand St. Shiraz Fars Iran (Islamic Republic of)