Comparing Effects of Beetroot Juice and Mediterranean Diet on Liver Enzymes and Sonography in Patients With NAFLD

Phase 1

Completed

• Conditions: NAFLD, Non-alcoholic Fatty Liver Disease
• Interventions: Other: placebo; Other: Mediterranean diet alone (MeD); Other: Beetroot juice; Combination Product: Mediterranean diet with beet juice (BJ+MeD)

• Registration Number: NCT05909631
• Lead Sponsor: Sulaimany Polytechnic university

Brief Summary

The goal of this clinical trial study is to investigate comparing Effects of Beetroot juice and Mediterranean diet on Liver Enzymes and Sonographic appearance in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD)

The main question\[s\] it aims to answer are:

1. Beetroot juice has role in reduce Liver Enzymes

2. Mediterranean diet has role in reduce Liver Enzymes

Detailed Description

Patients with NAFLD were identified and enrolled for this research at the PAR hospital in the Kurdistan Region of Iraq.

For 12 weeks, for the group members who were receiving the MeD, we recommended consuming Mediterranean foods like fish, poultry, sources of omega-3, vegetables and colored fruits, legumes and nuts, and low-fat goods while avoiding inflammatory foods like high-fat foods, processed meats, fast food, simple sugars, chips, and soft drinks.

At baseline, the participants' demographic and anthropometric information, including as gender, age, weight, height, smoking status, location of residence, and physical activity, were recorded.

Study Timeline

• Study Start: 2023-01-10
• Primary Completion: 2023-02-20
• Study Completion: 2023-04-11
• Study First Submitted: 2023-05-10
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-08
• Last Update Submitted: 2023-06-08
• Study First Posted: 2023-06-18
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Patients had to be between the ages of 19 and 73, and they had to have NAFLD as their main diagnosis.
2. For a NAFLD diagnosis, ultrasound proof of fatty liver (stage I or above) and an elevated level of liver enzymes were required.

Exclusion Criteria

1. history of diseases like cardiovascular, liver, chronic hepatitis C, and kidney disease
2. supplement use within the previous six months; hormone therapy; use of drugs like amiodarone, methotrexate, and corticosteroids
3. cases of starvation or inadequate nutrition; pregnancy; metabolic disorders like Wilson disease and glycogen storage disease; a history of liver irradiation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
250 ml of a placebo	placebo	250 ml of a placebo
Mediterranean diet alone (MeD)	Mediterranean diet alone (MeD)	Mediterranean diet alone (MeD)
beetroot juice (BJ)	Beetroot juice	250 ml of concentrated beetroot juice
Mediterranean diet with beet juice (BJ+MeD)	Mediterranean diet with beet juice (BJ+MeD)	Mediterranean diet with beet juice (BJ+MeD)

Primary Outcome Measures

Name	Time	Method
Beetroot juice has role in reduce liver enzymes	12 weeks	Beetroot juice was given for 12 weeks and has role in reduce Serum Bilirubin, alkaline phosphatase (ALP), alanine transaminase (ALT), and liver enzyme was measured by blood sampling tests.

Secondary Outcome Measures

Name	Time	Method
Mediterranean diet contributes to lower liver enzyme levels.	12 weeks	Mediterranean diet was given for 12 weeks and has role in reduce Serum Bilirubin, alkaline phosphatase (ALP), alanine transaminase (ALT), and liver enzyme was measured by blood sampling tests.

Trial Locations

Locations (1)

Hawal; 🇮🇶 Sulaymaniyah, Sulaimanyah, Iraq