Effects of Intermittent Fasting in Metabolic Dysfunction Associated Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Transient Elastography-Controlled Attenuation Parameter
研究概览
简要总结
Previous studies have investigated the effect of different dietary patterns on metabolic dysfunction-associated fatty liver disease (MAFLD), for which lifestyle modification remains the primary treatment. The present study sought to determine the effect of intermittent fasting on anthropometric measurements, fibroblast growth factor (FGF)-21, and autophagy markers including autophagy-related protein (ATG)-5 and BECLIN-1 levels, as well as on hepatic steatosis and fibrosis levels in overweight or obese patients with MAFLD to elucidate the efficacy of intermittent fasting in the management of MAFLD. The study included 48 patients diagnosed with MAFLD. Patients were randomly assigned into two groups: 22 received a dietary treatment involving 22-25 kcal/kg/day of energy for 8 weeks (energy-restricted diet group), and 26 followed the same dietary intervention and a 16:8 pattern (energy + time-restricted diet group). The patients were assessed for various parameters at baseline (T0) and at the end of the week 8 (T8). The extent of hepatic steatosis and fibrosis was determined using transient elastography on a FibroScan® device. Serum levels of FGF-21, BECLIN-1, and ATG-5 were determined using enzyme-linked immunosorbent assay.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with MAFLD
- •Aged 18-65 years
- •BMI ≥ 25 kg/m²
- •A stable body weight (<5 kg weight loss or gain) over the last 3 months preceding the start of the study
- •Signed the informed consent form.
排除标准
- •An average daily alcohol consumption >20 g for females and >30 g for males
- •Pregnant or lactating women
- •Patients with ischemic heart disease or heart failure, chronic inflammatory diseases, chronic viral infections, cancer, moderate-to-severe kidney disease, uncontrolled hypertension, and eating disorders
- •Those with a history of bariatric surgery
- •Those on insulin due to increased risk of hypoglycemia.
结局指标
主要结局
Transient Elastography-Controlled Attenuation Parameter
时间窗: Measurements were taken twice baseline and 8 weeks after the intervention.
The extent of hepatic steatosis and fibrosis was determined using transient elastography on a FibroScan® device. All FibroScan measurements were performed following the manufacturer's instructions as specified previously. Hepatic steatosis was defined using controlled attenuation parameter (CAP). The CAP measurement, which indicates steatosis, ranged between 100 and 400 dB/m.
Transient Elastography-Liver Stiffness Measurement
时间窗: Measurements were taken twice baseline and 8 weeks after the intervention.
The extent of hepatic steatosis and fibrosis was determined using transient elastography on a FibroScan® device. All FibroScan measurements were performed following the manufacturer's instructions as specified previously. The extent of hepatic steatosis and fibrosis was determined using transient elastography on a FibroScan® device. All FibroScan measurements were performed following the manufacturer's instructions as specified previously. Hepatic fibrosis were defined using liver stiffness measurement (LSM). LSM measurement ranged between 2.5 and 75 kPa.
次要结局
- Serum Fibroblast Growth Factor-21(Measurements were taken baseline before and 8 weeks after the intervention.)
- Serum Autophagy-Related Protein-5(Measurements were taken twice baseline and 8 weeks after the intervention.)
- Serum Beclin-1(Measurements were taken twice baseline and 8 weeks after the intervention.)
研究者
Tugce Ozlu Karahan
Assistant Professor
Istanbul Bilgi University