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临床试验/NCT05909631
NCT05909631已完成1 期

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

Sulaimany Polytechnic university2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2023年1月10日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
180
试验地点
2
主要终点
Beetroot juice has role in reduce liver enzymes

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Statical analyser

入排标准

年龄范围
19 Years 至 73 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Beetroot juice has role in reduce liver enzymes

时间窗: 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.

次要结局

  • Mediterranean diet contributes to lower liver enzyme levels.(12 weeks)

研究者

发起方
Sulaimany Polytechnic university
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hawal Lateef Fateh

Dr Hawal Lateef Fateh

Sulaimany Polytechnic university

研究点 (2)

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