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

Shaoguan University1 site in 1 country120 target enrollmentJanuary 1, 2018

ConditionsIntermittent Fasting Non-Alcoholic Fatty Liver Disease Insulin Resistance Obesity Gut Microbiota

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intermittent Fasting
Sponsor: Shaoguan University
Enrollment: 120
Locations: 1
Primary Endpoint: Body weight
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2018

End Date

August 31, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shaoguan University

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Body weight

Time Frame: Change from baseline body weight at week 8

Change of body weight

Secondary Outcomes

Gut microbiota(Change from baseline plasma bile acids and the gut microbiome at week 8)
Insulin resistance(Change from baseline plasma glucose and insulin at week 8)
Lipid profile(Change from baseline plasma TG, TC and LDL at week 8)