Intermittent Fasting in Nonalcoholic Fatty Liver Disease

Shaoguan University

Status: Unknown

Conditions: Gut Microbiota; Insulin Resistance; Obesity; Intermittent Fasting; Non-Alcoholic Fatty Liver Disease

Treatments: Behavioral: Calorie restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT04355910

SGU-05

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Intermittent fasting mimic-diet (IFD)

Experimental group

Description:

Restrict 75% energy on two non-consecutive days each week.

Treatment:

Behavioral: Calorie restriction

Continuous calorie restriction (CCR)

Active Comparator group

Description:

A daily 25% energy-restricted Mediterranean-type diet

Treatment:

Behavioral: Calorie restriction

Control

No Intervention group

Description:

No advice to restrict energy