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

NCT05909631 | Completed Phase 1 FDA Drug

• 1 other identifier: KTC1212
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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. 1.Beetroot juice has role in reduce Liver Enzymes
2. 2.Mediterranean diet has role in reduce Liver Enzymes

Conditions

NAFLD, Non-alcoholic Fatty Liver Disease

Keywords

Mediterranean diet; Beetroot juice; nonalcoholic fatty liver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mediterranean diet contributes to lower liver enzyme levels.

  12 weeks

Study Arms (4)

250 ml of a placebo

PLACEBO COMPARATOR

250 ml of a placebo

Other: placebo

beetroot juice (BJ)

EXPERIMENTAL

250 ml of concentrated beetroot juice

Other: Beetroot juice

Mediterranean diet with beet juice (BJ+MeD)

EXPERIMENTAL

Mediterranean diet with beet juice (BJ+MeD)

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

Mediterranean diet alone (MeD)

EXPERIMENTAL

Mediterranean diet alone (MeD)

Other: Mediterranean diet alone (MeD)

Interventions

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.

beetroot juice (BJ)

placebo OTHER

250 ml of a placebo

250 ml of a placebo

Mediterranean diet alone (MeD) OTHER

Mediterranean diet alone (MeD)

Mediterranean diet alone (MeD)

Mediterranean diet with beet juice (BJ+MeD) COMBINATION_PRODUCT

Mediterranean diet with beet juice (BJ+MeD).

Mediterranean diet with beet juice (BJ+MeD)

Eligibility Criteria

• Age: 19 Years - 73 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sulaimany Polytechnic university: lead

Study Sites (1)

Hawal

Sulaymaniyah, Sulaimanyah, 46021, Iraq

Location

Related Publications (1)

• Fateh HL, Rashid SA, Muhammad SS, Al-Jaf SH, Ali AM. Comparing effects of beetroot juice and Mediterranean diet on liver enzymes and sonographic appearance in patients with non-alcoholic fatty liver disease: a randomized control trials. Front Nutr. 2023 Aug 17;10:1181706. doi: 10.3389/fnut.2023.1181706. eCollection 2023.

  PMID: 37662597 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Hawal Lateef, Msc

  Nursing department, sulaimany polytechni university, kurdistan, iraq

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statical analyser
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Hawal Lateef Fateh

Model Details: 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.

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 18, 2023
• Study Start: January 10, 2023
• Primary Completion: February 20, 2023
• Study Completion: April 11, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)