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

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

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

Study Overview

• Status: Completed
• Conditions: NAFLD, Non-alcoholic Fatty Liver Disease
• Intervention / Treatment: Other: placebo; Other: Beetroot juice; Combination product: Mediterranean diet with beet juice (BJ+MeD); Other: Mediterranean diet alone (MeD)

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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 1

Contacts and Locations

Study Locations

• Iraq
  • Sulaimanyah
    • Sulaymaniyah, Sulaimanyah, Iraq, 46021
      • Hawal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 250 ml of a placebo	Other: placebo; 250 ml of a placebo
Experimental: beetroot juice (BJ); 250 ml of concentrated beetroot juice	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.
Experimental: Mediterranean diet with beet juice (BJ+MeD)	Combination product: Mediterranean diet with beet juice (BJ+MeD); Mediterranean diet with beet juice (BJ+MeD).
Experimental: Mediterranean diet alone (MeD)	Other: Mediterranean diet alone (MeD); Mediterranean diet alone (MeD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sulaimany Polytechnic university
• Investigators: Principal Investigator: Hawal Lateef, Msc, Nursing department, sulaimany polytechni university, kurdistan, iraq

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Actual): February 20, 2023
• Study Completion (Actual): April 11, 2023

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Estimated): June 19, 2023

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Mediterranean diet; Beetroot juice; nonalcoholic fatty liver
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: KTC1212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes