NCT04355910

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shaoguan University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-04-30
• Completion: 2020-08-31
• First posted: 2020-04-21
• Last updated: 2020-04-21

Locations

1 site across 1 country: China