Lifestyle Interventions for the Treatment of Non-alcoholic Fatty Liver Disease in Overweight and Obese Adults
1 other identifier
interventional
292
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2019
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2019
CompletedFirst Posted
Study publicly available on registry
June 3, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJune 13, 2019
June 1, 2019
9 months
May 31, 2019
June 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (6)
Change in BMI
6 month, 12 month
Change in liver function biomarkers
6 month, 12 month
Change in blood pressure
baseline, 3 month
Change in lipid
baseline, 3 month
Change in glycemic markers
baseline, 3 month
- +1 more secondary outcomes
Study Arms (2)
Lifestyle education
PLACEBO COMPARATORThe 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.
Intensive Lifestyle Intervention
EXPERIMENTALThe 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.
Interventions
Lifestyle education include the diet principles, physical activity guideline and behavioral strategies.
One to one intensive lifestyle intervention according to the diet and activity plan
A diet plan with restricted calorie and carbohydrate intake
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Liu Z, Jin P, Liu Y, Zhang Z, Wu X, Weng M, Cao S, Wang Y, Zeng C, Yang R, Liu C, Sun P, Tian C, Li N, Zeng Q. A comprehensive approach to lifestyle intervention based on a calorie-restricted diet ameliorates liver fat in overweight/obese patients with NAFLD: a multicenter randomized controlled trial in China. Nutr J. 2024 Jun 13;23(1):64. doi: 10.1186/s12937-024-00968-8.
PMID: 38872173DERIVEDSun 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.
PMID: 35571881DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhong Zhong, MD
First Affiliated Hospital of Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
May 31, 2019
First Posted
June 3, 2019
Study Start
July 1, 2019
Primary Completion
April 1, 2020
Study Completion
December 1, 2021
Last Updated
June 13, 2019
Record last verified: 2019-06