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

NAFLD, Non-alcoholic Fatty Liver Disease Clinical Trial

— BJ  

Official title:

Comparing Effects of Beetroot Juice and Mediterranean Diet on Liver Enzymes and Sonography in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD): A Randomized Control Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05909631
• Other study ID #: KTC1212
• Status: Completed
• Phase: Phase 1
• Start date: January 10, 2023
• Est. completion date: April 11, 2023

Study information

• Verified date: June 2023
• Source: Sulaimany Polytechnic university
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 11, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 73 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NAFLD, Non-alcoholic Fatty Liver Disease
• Non-alcoholic Fatty Liver Disease

Intervention

Other:
• Beetroot juice
250 ml of concentrated beetroot juice, were given to participants in the BJ groups .This was carried out in the morning, 30 minutes before breakfast, and on an empty stomach.
• placebo
250 ml of a placebo
• Mediterranean diet alone (MeD)
Mediterranean diet alone (MeD)

Combination Product:
• Mediterranean diet with beet juice (BJ+MeD)
Mediterranean diet with beet juice (BJ+MeD).

Locations

Country	Name	City	State
Iraq	Hawal	Sulaymaniyah	Sulaimanyah

Sponsors (1)

Lead Sponsor	Collaborator
Sulaimany Polytechnic university

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beetroot juice has role in reduce liver enzymes	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.	12 weeks
Secondary	Mediterranean diet contributes to lower liver enzyme levels.	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.	12 weeks