Intermittent Fasting in Nonalcoholic Fatty Liver Disease

NCT ID: NCT04355910

Last Updated: 2020-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-08-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intermittent fasting mimic-diet (IFD)

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

Group Type: EXPERIMENTAL

Calorie restriction

Intervention Type: BEHAVIORAL

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.

Continuous calorie restriction (CCR)

A daily 25% energy-restricted Mediterranean-type diet

Group Type: ACTIVE_COMPARATOR

Calorie restriction

Intervention Type: BEHAVIORAL

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.

Control

No advice to restrict energy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Medical University

UNKNOWN

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Shaoguan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guangdong Medical University

Dongguan, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Peiwen Zhang, M. D.

Role: primary

313743920@qq.com

86-769-22896572

Xuebin Gao, M. D.

Role: backup

401779114@qq.com

86-18819747104

Other Identifiers

SGU-05

Identifier Type: -

Identifier Source: org_study_id