Effect of 12-week Intermittent Calorie Restriction on Liver Fat Content in Comparison With Standard-of-care in Patients With Nonalcoholic Fatty Liver Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Impact of ICR on liver steatosis by MRI-PDFF
研究概览
简要总结
Several diets have been proposed to reduce liver steatosis in patients with nonalcoholic fatty liver disease (NAFLD), and various effects on liver steatosis have been observed. The objective of this trial is to compare the effects of intermittent calorie restriction (ICR) (5:2 diet) and standard-of-care (SoC) on reduction of hepatic steatosis.
详细描述
This is an open-label randomised controlled trial of patients with NAFLD. Patients are recruited in the Liver Outpatient Clinic of the Ewha Womans University Mokdong Hospital. The department of Nutritional Science and Food Management, Ewha Womans University will collaborate for this study.
About 72 patients (36 patients with body mass index [BMI] ≥25 kg/m2 and 36 patients with BMI <25 kg/m2) will be enrolled in a 1:1 ratio to 12 weeks treatment with either 5:2 diet (ICR group, 18 patients in each BMI group), or general lifestyle advice from a hepatologist (standard of care; SoC group, 18 patients in each BMI group).
Beginning in week 3 (Visit 2), an ICR group and a SoC group are generated through randomisation. Both arms will be accompanied for a duration of 12 weeks. After 12 weeks from the completion of the experimental phase (wash-out period), there will be the "end of follow up" visit.
The whole duration of the study is 26 weeks (2 weeks lead-in, 12 weeks intervention and 12 weeks post-intervention investigation).
Magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) and MR-Elastography are conducted at the screening visit and at weeks 12.
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NAFLD diagnosed by (1) Histologic assessment with a fat accumulation of more than 5% of the liver's weight in a biopsy, or (2) Radiologic assessment with a MRI-PDFF ≥8%.
- •Age between 19 and 75 years
- •Capability to understand the study and the individual consequences of participation
- •Signed and dated declaration of agreement in the forefront of the study
排除标准
- •Daily alcohol consumption >30 g in men and >20 g in women
- •Other causes of chronic liver disease (HBV, HCV, HDV, HEV, HIV), autoimmune diseases or chronic cholestatic liver disease, drug induced liver injury, hereditary haemochromatosis, Wilson disease, α-1-Antitrypsin deficiency
- •Liver cirrhosis
- •Hepatocellular carcinoma
- •Medications which cause liver disease or secondary NAFLD (e.g. Tamoxifen, systemic Corticosteroids, Methotrexate, Tetracycline, Estrogens, Valproic acid)
- •Changes in body weight > 5% in the last 3 months
- •Intake of medical treatment for NAFLD/NASH in the last 6 months (except for vitamin E)
- •Patients after organ transplantations
- •Missing or lacking consent capability
研究组 & 干预措施
ICR Arm
On 2 non-consecutive days per week, participants in the ICR (5:2 diet) group will be instructed to consume 500 kcal/day for women and 600 kcal/day for men.
干预措施: Intermittent calorie restriction (Behavioral)
Soc Arm
The SoC group will receive 80% of standard calorie (1,200-1,500 kcal/day or reducing 500-1000 kcal/day from standard calorie).
干预措施: Standard of care (Behavioral)
结局指标
主要结局
Impact of ICR on liver steatosis by MRI-PDFF
时间窗: Baseline, 12 weeks
The primary outcome of interest is a change in MRI-PDFF value of a least 30% with ICR
次要结局
- Changes in visceral adipose tissue (VAT)(Baseline, 12, and 24 weeks)
- Genetic analysis(Baseline)
- Changes in anthropometrics(Baseline, 12, and 24 weeks)
- Changes in gut microbiota(Baseline, 12 weeks)
- Changes in liver fibrosis by MR-Elastography(Baseline, 12 weeks)
- Changes in body composition analysis (BCA)(Baseline, 12, and 24 weeks)
- Changes in hormone(Baseline, 12 weeks)
- Changes in liver metabolite(Baseline, 12 weeks)
- Changes in quality of life score(Baseline, 12, and 24 weeks)
研究者
Hwi Young Kim
Professor
Ewha Womans University Mokdong Hospital