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IRCT20100524004010N42 IRCT 2025-10-20 Shahid Beheshti University of Medical Sciences The Effect of Beetroot Extract supplementation on metabolic, hepatic, andinflammation parameters in patients with metabolic-dysfunction associatedSteatotic liver disease. The Effect of Beetroot Extract supplementation on metabolic, hepatic, and inflammation parameters in patients with metabolic-dysfunction associated Steatotic liver disease. 2025-10-23 anticipated 50 Complete https://irct.ir/trial/85960 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients were categorized into three groups based on their Body Mass Index (BMI): Group 1 with BMI between 25 and 30 (<30), Group 2 with BMI between 30 and 35 (<35), and Group 3 with BMI between 35 and 40. Using a randomized block design, participants in each BMI category were randomly assigned to either the beetroot extract supplementation group or the placebo group. To ensure balanced allocation, a stratified blocked randomization method was applied, with separate randomization conducted within each BMI stratum. The block size was set at four, including two allocations to Group A (beetroot extract) and two allocations to Group B (placebo). Six possible permutations of allocation sequences were used: AABB, ABAB, BBAA, BABA, ABBA, and BAAB, Blinding description: For blinding purposes, an independent individual outside the research team is responsible for preparing the supplement and placebo, which are randomly assigned and labeled as groups A and B. Neither participants, investigators, nor outcome assessors are aware of the allocation (supplement or placebo) until the completion of the study and data analysis. The group codes will be disclosed only after data analyses have been completed, at the stage of manuscript preparation. 3 Fatty liver. Intervention 1: ntervention group: Participants in this group received beetroot extract supplementation (1 g per day equivalent to two 500mgr tablets) in combination with a calorie-restricted weight loss diet. Intervention 2: Control group: Participants in this group received a placebo (1 g per day, equivalent to two placebo capsules identical in appearance to the supplement) in combination with a calorie-restricted weight loss diet. 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 No further information.
public Azita Hekmatdoost
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7486 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences scientific Azita Hekmatdoost
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7486 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 65 years old Diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD) confirmed by a gastroenterology subspecialist Liver steatosis score >263 on FibroScan Body mass index (BMI) >25 18 years 65 years Both Lack of willingness to continue participation or non-adherence to the intervention Pregnancy or lactation Alcohol consumption Presence of other liver diseases Presence of cirrhosis or hepatocellular carcinoma Use of corticosteroid medications such as prednisolone, hydrocortisone, or betamethasone Use of hepatotoxic drugs such as tamoxifen, phenytoin, amoxifen, or lithium Use of liver-affecting supplements (e.g., fiber, omega-3, antioxidants) during the past 6 months Changes in medications (lipid-lowering agents, antidiabetic drugs) during study participation Use of weight-loss drugs or supplements Following any type of weight-loss diet within the past 3 months Weight reduction greater than 10% in the last 6 months (prior to enrollment) K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Placebo ntervention group: Participants in this group received beetroot extract supplementation (1 g per day equivalent to two 500mgr tablets) in combination with a calorie-restricted weight loss diet. Control group: Participants in this group received a placebo (1 g per day, equivalent to two placebo capsules identical in appearance to the supplement) in combination with a calorie-restricted weight loss diet. Hepatic steatosis. Timepoint: Before intervention and after 12 weeks. Method of measurement: Fibroscan. Blood glucose profile. Timepoint: At the beginning and end of the study (week 12). Method of measurement: Blood test. Blood lipid profile. Timepoint: At the beginning and end of the study (week 12). Method of measurement: Blood test. Liver enzymes. Timepoint: At the beginning and end of the study (week 12). Method of measurement: Blood test. C-reactive Protein. Timepoint: At the beginning and end of the study (week 12). Method of measurement: Blood test. Shahid Beheshti University of Medical Sciences Approved 2025-08-05 National nutrition and food technology research institute No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town, Tehran Tehran Iran (Islamic Republic of)