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

Study Overview
=================
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: Beetroot juice has role in reduce Liver Enzymes 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.

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

Conditions
-----------------
NAFLD, Non-alcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Other: Beetroot juice
* Other: placebo
* Other: Mediterranean diet alone (MeD)
* Combination Product: Mediterranean diet with beet juice (BJ+MeD)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients had to be between the ages of 19 and 73, and they had to have NAFLD as their main diagnosis. For a NAFLD diagnosis, ultrasound proof of fatty liver (stage I or above) and an elevated level of liver enzymes were required. Exclusion Criteria: history of diseases like cardiovascular, liver, chronic hepatitis C, and kidney disease supplement use within the previous six months; hormone therapy; use of drugs like amiodarone, methotrexate, and corticosteroids cases of starvation or inadequate nutrition; pregnancy; metabolic disorders like Wilson disease and glycogen storage disease; a history of liver irradiation

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 73 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The participants were split into four groups: control, Mediterranean diet with beet juice (BJ+MeD), Mediterranean diet alone (MeD) and beetroot juice (BJ). The Mediterranean diet included fruits, vegetables, fish, poultry, and other lean meats (without skin), sources of omega-3 fatty acids, nuts, and legumes. Beetroot juice had 250 mg of beetroot.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 250 ml of a placebo<br>250 ml of a placebo | Other: placebo<br>* 250 ml of a placebo<br>|
| Experimental: beetroot juice (BJ)<br>250 ml of concentrated beetroot juice | Other: Beetroot juice<br>* 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.<br>|
| Experimental: Mediterranean diet with beet juice (BJ+MeD)<br>Mediterranean diet with beet juice (BJ+MeD) | Combination Product: Mediterranean diet with beet juice (BJ+MeD)<br>* Mediterranean diet with beet juice (BJ+MeD).<br>|
| Experimental: Mediterranean diet alone (MeD)<br>Mediterranean diet alone (MeD) | Other: Mediterranean diet alone (MeD)<br>* Mediterranean diet alone (MeD)<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mediterranean diet, Beetroot juice, nonalcoholic fatty liver