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Completed

NCT Number: NCT05909631

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

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

Completed

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Key information

Age range

19 year–73 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hawal

Sulaymaniyah, Sulaimanyah, 46021, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beetroot Juice

Other

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

Other

250 ml of a placebo

Mediterranean diet alone (MeD)

Other

Mediterranean diet alone (MeD)

Mediterranean diet with beet juice (BJ+MeD)

Combination Product

Mediterranean diet with beet juice (BJ+MeD).

Primary outcomes

  1. Beetroot juice has role in reduce liver enzymes

    Time frame: 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 outcomes

  1. Mediterranean diet contributes to lower liver enzyme levels.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sulaimani Polytechnic University

Other

Registry information

Official study 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

Acronym: BJ

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2023
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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