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

• Sponsor: Sulaimany Polytechnic university (Other)
• Overall Status: Completed
• CT.gov ID: NCT05909631
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arms: 4
• Actual Duration (Months): 3
• Patients Per Site Per Month: 60.2

Study Details

Study Description

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:

1. Beetroot juice has role in reduce Liver Enzymes

2. Mediterranean diet has role in reduce Liver Enzymes

Condition or Disease	Intervention/Treatment	Phase
NAFLD, Non-alcoholic Fatty Liver Disease	Other: Beetroot juice; Other: placebo; Other: Mediterranean diet alone (MeD); Combination Product: Mediterranean diet with beet juice (BJ+MeD)	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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 (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Statical analyser
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 10, 2023
• Actual Primary Completion Date: Feb 20, 2023
• Actual Study Completion Date: Apr 11, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 250 ml of a placebo 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) 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) Mediterranean diet alone (MeD)	Other: Mediterranean diet alone (MeD); Mediterranean diet alone (MeD)

Outcome Measures

Primary Outcome Measures

1. Beetroot juice has role in reduce liver enzymes [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 Outcome Measures

1. Mediterranean diet contributes to lower liver enzyme levels. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 73 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hawal	Sulaymaniyah	Sulaimanyah	Iraq	46021

Sponsors and Collaborators

• Sulaimany Polytechnic university

Investigators

• Principal Investigator: Hawal Lateef, Msc, Nursing department, sulaimany polytechni university, kurdistan, iraq

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hawal Lateef Fateh, Dr Hawal Lateef Fateh, Sulaimany Polytechnic university
• ClinicalTrials.gov Identifier: NCT05909631
• Other Study ID Numbers: KTC1212
• First Posted: Jun 18, 2023
• Last Update Posted: Jun 18, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Hawal Lateef Fateh, Dr Hawal Lateef Fateh, Sulaimany Polytechnic university: Mediterranean diet; Beetroot juice; nonalcoholic fatty liver
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Jun 18, 2023