Intermittent Fasting in Nonalcoholic Fatty Liver Disease

Not Applicable

• Conditions: Insulin Resistance; Non-Alcoholic Fatty Liver Disease; Intermittent Fasting; Obesity; Gut Microbiota
• Interventions: Behavioral: Calorie restriction

• Registration Number: NCT04355910
• Lead Sponsor: Shaoguan University

Brief Summary

Although preliminary evidence suggests that intermittent fasting mimic-diet (IFD) exerts stronger effects on body weight and metabolic parameters, which may link obesity, non-alcoholic fatty liver disease (NAFLD) and major chronic diseases, compared with continuous calorie restriction (CCR), there is a lack of well-powered intervention studies. This randomized controlled trial will test whether IFD, operationalized as the "5:2 diet," has stronger effects on anthropometric and body composition characteristics, and circulating metabolic biomarkers than CCR and a control regimen in adults with NAFLD.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-19
• Last Update Submitted: 2020-04-19
• Study First Posted: 2020-04-21
• Last Update Posted: 2020-04-21
• Primary Completion: 2020-04-30
• Study Completion: 2020-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• The diagnosed criteria of fatty liver by ultrasound were presence of two of the three following criteria: increased hepatic echogenicity compared with cortical of the right kidney, blurring of liver vasculature, and deep attenuation of the ultrasonographic signal.

Exclusion Criteria

• Excessive alcohol consumption (ethanol > 140 g/wk for men and > 70 g/wk for women), cirrhosis, viral hepatitis, cardiovascular disease, cancer, any consumption of nonsteroidal anti-inflammatory drugs, corticosteroids or prescriptive medicine that affect liver function, lipid and glucose metabolism.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent fasting mimic-diet (IFD)	Calorie restriction	Restrict 75% energy on two non-consecutive days each week.
Continuous calorie restriction (CCR)	Calorie restriction	A daily 25% energy-restricted Mediterranean-type diet

Primary Outcome Measures

Name	Time	Method
Body weight	Change from baseline body weight at week 8	Change of body weight

Secondary Outcome Measures

Name	Time	Method
Gut microbiota	Change from baseline plasma bile acids and the gut microbiome at week 8	Changes of blood metabolites and the gut microbiome
Lipid profile	Change from baseline plasma TG, TC and LDL at week 8	Plasma lipids levels
Insulin resistance	Change from baseline plasma glucose and insulin at week 8	Plasma glucose and insulin levels

Trial Locations

Locations (1)

Guangdong Medical University; 🇨🇳 Dongguan, Guangdong, China