The Effect of Beetroot Extract supplementation on metabolic, hepatic, and inflammation parameters in patients with metabolic-dysfunction associated Steatotic liver disease.

The Effect of Beetroot Extract supplementation on metabolic, hepatic, and inflammation parameters in patients with metabolic-dysfunction associated Steatotic liver disease.

A phase 3 randomized, double-blind, controlled, parallel-group clinical trial on 50 patients.

This study is conducted at Behbood clinic. Patients with fatty liver disease who met the eligibility criteria were enrolled after providing written informed consent. At baseline, demographic data, weight, height, fasting blood samples, and 24-hour dietary recall were collected. Participants were categorized by BMI and randomly assigned, using block randomization, to receive either beetroot extract supplement (1 g daily for 12 weeks) or placebo. Both groups followed a hypocaloric diet. For blinding, the supplement and placebo capsules were coded as A and B, ensuring that neither patients nor investigators were aware of group assignments.

Entry criteria: 1.Age 18–65 years 2.Steatosis degree above 263 on FibroScan 3.BMI > 25 Exclusion criteria: 1.Unwillingness to continue the trial or non-adherence to the intervention 2.Pregnancy or lactation 3.Alcohol consumption 4.Presence of other liver diseases 5.Presence of cirrhosis or hepatic cancer 6.Use of corticosteroid medications 7.Use of hepatotoxic drugs 8.Use of liver-affecting supplements within the past 6 months 9.Changes in medication use 10.Use of weight-loss medications or supplements 11.Following any type of weight-loss diet within the past 3 months

Beetroot extract (1000 mGr/daily)

Weight, waist circumference, hip circumference, waist-to-hip ratio (WHR), fasting blood glucose (FBG), liver enzymes, C-reactive protein (CRP), lipid profile, hepatic steatosis and fibrosis, insulin.

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.

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.