Intermittent Fasting in Nonalcoholic Fatty Liver Disease

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04355910
• Other study ID #: SGU-05
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: April 2020
• Source: Shaoguan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Gut Microbiota
• Insulin Resistance
• Intermittent Fasting
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Obesity

Intervention

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.

Locations

Country	Name	City	State
China	Guangdong Medical University	Dongguan	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Shaoguan University	Guangdong Medical University, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Change of body weight	Change from baseline body weight at week 8
Secondary	Lipid profile	Plasma lipids levels	Change from baseline plasma TG, TC and LDL at week 8
Secondary	Insulin resistance	Plasma glucose and insulin levels	Change from baseline plasma glucose and insulin at week 8
Secondary	Gut microbiota	Changes of blood metabolites and the gut microbiome	Change from baseline plasma bile acids and the gut microbiome at week 8