Lifestyle Interventions for the Treatment of Non-alcoholic Fatty Liver Disease in Overweight and Obese Adults

Lifestyle intervention is the most important management of non-alcoholic fatty liver diseases (NAFLD) patients. Weight reductions of 5-10% can improve non-alcoholic steatosis and fibrosis. However, the options for treatment in the clinics are limited. Therefore, in this study, we investigated the effectiveness of different lifestyle intervention strategies in NAFLD patients.

Study Overview

• Status: Unknown
• Conditions: Obesity; Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Behavioral: Lifestyle education; Behavioral: Intensive lifestyle intervention; Behavioral: Hypocaloric low-carbohydrate diet plan

Detailed Description

This is a multicenter, randomized clinical trial nested within a cohort study in overweight and obese non-alcoholic fatty liver diseases (NAFLD) patients. In this study, 1500 eligible patients will be recruited, and demographic information and clinical data will be collected at baseline. Among these, 292 participants who agree to be randomized will be randomized into two intervention groups, including lifestyle education (LE), and intensive lifestyle intervention with low-carbohydrate diet (ILI), aiming to induce a loss ≥ 10% of initial weight in 3 months. The remainder will chose the treatment which they prefer according to the clinical practice. At the 3th, 6th and 12th month, all the participants will be followed, and data will be collected to study the development of NAFLD in different lifestyle intervention groups.

• Study Type: Interventional
• Enrollment (Anticipated): 292
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Man or women aged 18-65 years;
• Confirmed diagnosis of NAFLD according to the 2018 Chinese Guidelines for Prevention and Treatment of NAFLD;
• Body mass index (BMI)of 25.0 to 35.0 kg/m2;
• Patients without medicine for treatment of NAFLD;

Exclusion Criteria:

• Patients with other diseases that can lead to fatty liver;
• Patients use amiodaron, methotrexate, tamoxifen, glucocorticoid, estrogen, and the other medications that affect weight within 3 months;
• Patients with serious liver dysfunction (AST or/and ALT >3 times of the upper limit of normal), or renal dysfunction (serum creatinine >the upper limit of normal);
• Patients with diseases that need control of dietary protein intake;
• Patients with diseases that affect food digestion and absorption;
• Patients with diagnosed diabetes or those with significantly elevated blood glucose (fasting blood glucose ≥7.0 mmol/L and/or random blood glucose ≥11.1 mmol/L);
• Patients with severe cardiovascular and cerebrovascular diseases or severe hypertension (Grade 3); anemia; mental illness or memory disorder; epilepsy or antiepileptic treatment;
• Patients with secondary obesity;
• Patients with cancer, active tuberculosis, AIDS and other infectious diseases;
• Pregnancy or lactation;
• Physical disability.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Lifestyle education; The participants in this group will be provided usual recommendation, including the diet principles, activity guideline and behavioral strategies at baseline. In addition, the participants will have access to an APP, with which the participants could learn more information of body weight management, and keep records of diet, activity and body weight during the study.	Behavioral: Lifestyle education; Lifestyle education include the diet principles, physical activity guideline and behavioral strategies.
Experimental: Intensive Lifestyle Intervention; The participants in this group will be provided a comprehensive intervention, including goal setting, one to one support by the lifestyle counselors, and meal replacement products, in addition to the information and APP which are provided to the Lifestyle education group.	Behavioral: Lifestyle education; Lifestyle education include the diet principles, physical activity guideline and behavioral strategies.; Behavioral: Intensive lifestyle intervention; One to one intensive lifestyle intervention according to the diet and activity plan; Behavioral: Hypocaloric low-carbohydrate diet plan; A diet plan with restricted calorie and carbohydrate intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BMI		baseline, 3 month
Change in liver function biomarkers	ALT, AST	baseline, 3 month
Liver Stiffness Measurement	LSM is suggested as degree of liver fibrosis	baseline, 3 month
Fast Ultrasound Attenuation Parameter	FAP is suggested as degree of liver steatosis.	baseline, 3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BMI		6 month, 12 month
Change in liver function biomarkers	ALT, AST	6 month, 12 month
Change in blood pressure		baseline, 3 month
Change in lipid	triglyceride, total cholesterol , LDL-C, and HDL-C	baseline, 3 month
Change in glycemic markers	fasting glucose, fasting insulin, HbA1C	baseline, 3 month
Change in body composition	muscle mass, fat percentage	baseline, 3 month

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Investigators: Principal Investigator: Zhong Zhong, MD, First Affiliated Hospital of Zhejiang University

Publications and helpful links

General Publications

• Sun P, Huang L, Shuai P, Wan Z, Liu Y, Xue J, Liu Y. Effect of a High Protein, Low Glycemic Index Dietary Intervention on Metabolic Dysfunction-Associated Fatty Liver Disease: A Randomized Controlled Trial. Front Nutr. 2022 Apr 27;9:863834. doi: 10.3389/fnut.2022.863834. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2019
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Actual): June 13, 2019
• Last Update Submitted That Met QC Criteria: June 11, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Lifestyle interventions; Low-carbohydrate diet
• Additional Relevant MeSH Terms: Digestive System Diseases; Body Weight; Liver Diseases; Fatty Liver; Overweight; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: CHPF2018-NALFD-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No