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

Primary Purpose

NAFLD, Non-alcoholic Fatty Liver Disease

Status
Completed
Phase
Phase 1
Locations
Iraq
Study Type
Interventional
Intervention
Beetroot juice
placebo
Mediterranean diet alone (MeD)
Mediterranean diet with beet juice (BJ+MeD)
Sponsored by
Sulaimany Polytechnic university
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAFLD, Non-alcoholic Fatty Liver Disease focused on measuring Mediterranean diet, Beetroot juice, nonalcoholic fatty liver

Eligibility Criteria

19 Years - 73 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hawal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

250 ml of a placebo

beetroot juice (BJ)

Mediterranean diet with beet juice (BJ+MeD)

Mediterranean diet alone (MeD)

Arm Description

250 ml of a placebo

250 ml of concentrated beetroot juice

Mediterranean diet with beet juice (BJ+MeD)

Mediterranean diet alone (MeD)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 10, 2023
Last Updated
June 8, 2023
Sponsor
Sulaimany Polytechnic university
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1. Study Identification

Unique Protocol Identification Number
NCT05909631
Brief Title
Comparing Effects of Beetroot Juice and Mediterranean Diet on Liver Enzymes and Sonography in Patients With NAFLD
Acronym
BJ
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
February 20, 2023 (Actual)
Study Completion Date
April 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sulaimany Polytechnic university

4. Oversight

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
Data Monitoring Committee
No

5. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD, Non-alcoholic Fatty Liver Disease
Keywords
Mediterranean diet, Beetroot juice, nonalcoholic fatty liver

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Statical analyser
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
250 ml of a placebo
Arm Type
Placebo Comparator
Arm Description
250 ml of a placebo
Arm Title
beetroot juice (BJ)
Arm Type
Experimental
Arm Description
250 ml of concentrated beetroot juice
Arm Title
Mediterranean diet with beet juice (BJ+MeD)
Arm Type
Experimental
Arm Description
Mediterranean diet with beet juice (BJ+MeD)
Arm Title
Mediterranean diet alone (MeD)
Arm Type
Experimental
Arm Description
Mediterranean diet alone (MeD)
Intervention Type
Other
Intervention Name(s)
Beetroot juice
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
250 ml of a placebo
Intervention Type
Other
Intervention Name(s)
Mediterranean diet alone (MeD)
Intervention Description
Mediterranean diet alone (MeD)
Intervention Type
Combination Product
Intervention Name(s)
Mediterranean diet with beet juice (BJ+MeD)
Intervention Description
Mediterranean diet with beet juice (BJ+MeD).
Primary Outcome Measure Information:
Title
Beetroot juice has role in reduce liver enzymes
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Mediterranean diet contributes to lower liver enzyme levels.
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hawal Lateef, Msc
Organizational Affiliation
Nursing department, sulaimany polytechni university, kurdistan, iraq
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hawal
City
Sulaymaniyah
State/Province
Sulaimanyah
ZIP/Postal Code
46021
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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