Intermittent Fasting in Nonalcoholic Fatty Liver Disease

NCT04355910 | Unknown

• 1 other identifier: SGU-05
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Body weight

  Change of body weight

  Change from baseline body weight at week 8

Secondary Outcomes (3)

• Lipid profile

  Change from baseline plasma TG, TC and LDL at week 8

• Insulin resistance

  Change from baseline plasma glucose and insulin at week 8

• Gut microbiota

  Change from baseline plasma bile acids and the gut microbiome at week 8

Study Arms (3)

Intermittent fasting mimic-diet (IFD)

EXPERIMENTAL

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

Behavioral: Calorie restriction

Continuous calorie restriction (CCR)

ACTIVE COMPARATOR

A daily 25% energy-restricted Mediterranean-type diet

Behavioral: Calorie restriction

Control

NO INTERVENTION

No advice to restrict energy

Interventions

Calorie restriction 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); Intermittent fasting mimic-diet (IFD)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaoguan University: lead
• Guangdong Medical University: collaborator
• Sun Yat-sen University: collaborator

Study Sites (1)

Guangdong Medical University

Dongguan, Guangdong, 523808, China

RECRUITING

MeSH Terms

Conditions

Intermittent Fasting; Non-alcoholic Fatty Liver Disease; Insulin Resistance; Obesity

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Fatty Liver; Liver Diseases; Digestive System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The patient is represented in code
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 21, 2020
• Study Start: January 1, 2018
• Primary Completion: April 30, 2020
• Study Completion: August 31, 2020
• Last Updated: April 21, 2020

Record last verified: 2020-04

Locations

CN (1)