Intermittent Fasting in Nonalcoholic Fatty Liver Disease

Effects of Intermittent and Continuous Calorie Restriction on Body Weight and Metabolism in Adults With Nonalcoholic Fatty Liver Disease

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Insulin Resistance; Gut Microbiota; Non-Alcoholic Fatty Liver Disease; Intermittent Fasting
• Intervention / Treatment: Behavioral: Calorie restriction

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Dongguan, Guangdong, China, 523808
      • Recruiting
      • Guangdong Medical University
      • Contact: Peiwen Zhang, M. D.; Phone Number: 86-769-22896572; Email: 313743920@qq.com
      • Contact: Xuebin Gao, M. D.; Phone Number: 86-18819747104; Email: 401779114@qq.com
      • Sub-Investigator: Peiwen Zhang, M. D.
      • Principal Investigator: Honghui Guo, Ph. D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intermittent fasting mimic-diet (IFD); Restrict 75% energy on two non-consecutive days each week.	Behavioral: Calorie restriction; Participants randomized to IFD were asked to restrict energy and carbohydrate on two non-consecutive days each week (75% energy restriction) and to consume a plant foods-based diet that met their estimated energy requirements for the remaining 5 d of the week. The CCR group was prescribed a daily plant foods-based diet that was relatively low in fat with moderate energy-restriction (25% energy restriction). The plant foods-based diet included adequate fruit and vegetable, nuts and seeds, whole-grain cereals, olive oil, fish and seafood, a moderate consumption of dairy products, poultry, eggs, and lean red meat.
Active Comparator: Continuous calorie restriction (CCR); A daily 25% energy-restricted Mediterranean-type diet	Behavioral: Calorie restriction; Participants randomized to IFD were asked to restrict energy and carbohydrate on two non-consecutive days each week (75% energy restriction) and to consume a plant foods-based diet that met their estimated energy requirements for the remaining 5 d of the week. The CCR group was prescribed a daily plant foods-based diet that was relatively low in fat with moderate energy-restriction (25% energy restriction). The plant foods-based diet included adequate fruit and vegetable, nuts and seeds, whole-grain cereals, olive oil, fish and seafood, a moderate consumption of dairy products, poultry, eggs, and lean red meat.
No Intervention: Control; No advice to restrict energy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Change of body weight	Change from baseline body weight at week 8

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shaoguan University
• Collaborators: Sun Yat-sen University; Guangdong Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): August 31, 2020

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 19, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 19, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Liver Diseases; Fatty Liver; Insulin Resistance; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: SGU-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No