Prevalence of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) Among Nurses in a Single Tertiary Care Centre and the Role of Intermittent Fasting in Improving Hepatic Steatosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean change of controlled attenuated parameter (CAP) (dB/m)
研究概览
简要总结
This study consists of 2 parts:
Part 1: a cross-sectional study, looking at the prevalence of metabolic dysfunction-associated fatty liver disease (MAFLD) among nurses in Hospital Canselor Tuanku Muhriz (HCTM).
Part 2: a randomized controlled trial of intermittent fasting with MAFLD subjects.
详细描述
The investigators aim to screen at least 350 participants for fibroscan-detected fatty liver. Baseline anthropometric data will be taken. Questionnaires on dietary habits - Foof Frequency Questionnaire (FFQ) and exercise habits - International Physical Activity Questionnaire (IPAQ) will be done.
Approximately 100 participants who have fatty liver from Part 1 study, will be enrolled and randomized into Part 2. The intervention group will undergo intermittent fasting (3 fasting day:4 non-fasting days) while the control group will continue the usual standard care, for 8 weeks.
Measurements pre- and post-intervention include Fibroscan measurement, blood LiverFASt, anthropometric data, and exercise habit (IPAQ).
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •nurses at HCTM, 18 years and above
排除标准
- •pregnancy
- •previous bariatric surgery
- •liver cirrhosis
- •liver cancer
- •steatogenic drugs
研究组 & 干预措施
Intermittent Fasting Group
IF regime: 3 fasting day: 4 non-fasting day. On fasting day - allows to eat restricted calorie diet (up to 70% total daily calorie intake) for 8 hours.
干预措施: Intermittent Fasting (Behavioral)
Non-Fasting Group
Usual care. Not allowed to fast
结局指标
主要结局
Mean change of controlled attenuated parameter (CAP) (dB/m)
时间窗: 8 weeks
hepatic steatosis score - measured by transient elastography (Fibroscan). The higher the value, the more severe the degree of steatosis. Range of score: 100-500dB/m
次要结局
- mean change of Body Mass Index(8 weeks)
- Mean change of hepatic fibrosis score (kPa)(8 weeks)
- Mean change of steatotest, actitest, and fibrotest scores(8 weeks)
研究者
Khairul Najmi
Dr
Universiti Kebangsaan Malaysia Medical Centre