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

Sulaimany Polytechnic university

Status and phase: Completed; Phase 1

Conditions: NAFLD, Non-alcoholic Fatty Liver Disease

Treatments: Combination Product: Mediterranean diet with beet juice (BJ+MeD); Other: Mediterranean diet alone (MeD); Other: placebo; Other: Beetroot juice

Study type: Interventional

Funder types: Other

Identifiers

NCT05909631

KTC1212

Details and patient eligibility

About

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

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 19 to 73 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 4 patient groups, including a placebo group

250 ml of a placebo

Placebo Comparator group

Description:

250 ml of a placebo

Treatment:

Other: placebo

beetroot juice (BJ)

Experimental group

Description:

250 ml of concentrated beetroot juice

Treatment:

Other: Beetroot juice

Mediterranean diet with beet juice (BJ+MeD)

Experimental group

Description:

Mediterranean diet with beet juice (BJ+MeD)

Treatment:

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

Mediterranean diet alone (MeD)

Experimental group

Description:

Mediterranean diet alone (MeD)

Treatment:

Other: Mediterranean diet alone (MeD)