Intermittent Fasting in Nonalcoholic Fatty Liver Disease

Sponsor

Shaoguan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04355910

Collaborator

Guangdong Medical University (Other), Sun Yat-sen University (Other)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intermittent Fasting Non-Alcoholic Fatty Liver Disease Insulin Resistance Obesity Gut Microbiota	Behavioral: Calorie restriction	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

The patient is represented in code

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Anticipated Primary Completion Date :

Apr 30, 2020

Anticipated Study Completion Date :

Aug 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intermittent fasting mimic-diet (IFD) Restrict 75% energy on two non-consecutive days each week.	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.
Active Comparator: Continuous calorie restriction (CCR) A daily 25% energy-restricted Mediterranean-type diet	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.
No Intervention: Control No advice to restrict energy

Arm

Intervention/Treatment

Experimental: Intermittent fasting mimic-diet (IFD)

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

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.

Active Comparator: Continuous calorie restriction (CCR)

A daily 25% energy-restricted Mediterranean-type diet

Behavioral: Calorie restriction

No Intervention: Control

No advice to restrict energy

Outcome Measures

Primary Outcome Measures

Body weight [Change from baseline body weight at week 8]
Change of body weight

Secondary Outcome Measures

Lipid profile [Change from baseline plasma TG, TC and LDL at week 8]
Plasma lipids levels
Insulin resistance [Change from baseline plasma glucose and insulin at week 8]
Plasma glucose and insulin levels
Gut microbiota [Change from baseline plasma bile acids and the gut microbiome at week 8]
Changes of blood metabolites and the gut microbiome

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangdong Medical University	Dongguan	Guangdong	China	523808

Sponsors and Collaborators

Shaoguan University
Guangdong Medical University
Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shaoguan University

ClinicalTrials.gov Identifier:

NCT04355910

Other Study ID Numbers:

SGU-05

First Posted:

Apr 21, 2020

Last Update Posted:

Apr 21, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Liver Diseases

Fatty Liver

Non-alcoholic Fatty Liver Disease

Insulin Resistance

Study Results

No Results Posted as of Apr 21, 2020