Clinical trial NCT05909631: Comparing Effects of Beetroot Juice and Mediterranean Diet on Liver Enzymes and Sonography in Patients With NAFLD
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
Overall status: COMPLETED
Phase: PHASE1
Conditions: NAFLD, Non-alcoholic Fatty Liver Disease
Keywords: Mediterranean diet
Beetroot juice
nonalcoholic fatty liver
Lead sponsor: Sulaimany Polytechnic university
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 180
Sex: ALL
Minimum age (years): 19
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Beetroot juice has role in reduce liver enzymes
timeFrame: 12 weeks
Secondary outcomes:
measure: Mediterranean diet contributes to lower liver enzyme levels.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sulaymaniyah
country: Iraq
facility: Hawal
state: Sulaimanyah
Study officials:
affiliation: Nursing department, sulaimany polytechni university, kurdistan, iraq
name: Hawal Lateef, Msc
role: PRINCIPAL_INVESTIGATOR
References: