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

Primary Purpose

Non-Alcoholic Fatty Liver Disease, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lifestyle education
Intensive lifestyle intervention
Hypocaloric low-carbohydrate diet plan
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring Lifestyle interventions, Low-carbohydrate diet

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Lifestyle education

    Intensive Lifestyle Intervention

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in BMI
    Change in liver function biomarkers
    ALT, AST
    Liver Stiffness Measurement
    LSM is suggested as degree of liver fibrosis
    Fast Ultrasound Attenuation Parameter
    FAP is suggested as degree of liver steatosis.

    Secondary Outcome Measures

    Change in BMI
    Change in liver function biomarkers
    ALT, AST
    Change in blood pressure
    Change in lipid
    triglyceride, total cholesterol , LDL-C, and HDL-C
    Change in glycemic markers
    fasting glucose, fasting insulin, HbA1C
    Change in body composition
    muscle mass, fat percentage

    Full Information

    First Posted
    May 31, 2019
    Last Updated
    June 11, 2019
    Sponsor
    First Affiliated Hospital of Zhejiang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03972631
    Brief Title
    Lifestyle Interventions for the Treatment of Non-alcoholic Fatty Liver Disease in Overweight and Obese Adults
    Official Title
    Lifestyle Interventions for the Treatment of Non-alcoholic Fatty Liver Disease in Overweight and Obese Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2019 (Anticipated)
    Primary Completion Date
    April 2020 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    First Affiliated Hospital of Zhejiang University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Alcoholic Fatty Liver Disease, Obesity
    Keywords
    Lifestyle interventions, Low-carbohydrate diet

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    292 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Lifestyle education
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    Intensive Lifestyle Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Lifestyle education
    Intervention Description
    Lifestyle education include the diet principles, physical activity guideline and behavioral strategies.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Intensive lifestyle intervention
    Intervention Description
    One to one intensive lifestyle intervention according to the diet and activity plan
    Intervention Type
    Behavioral
    Intervention Name(s)
    Hypocaloric low-carbohydrate diet plan
    Intervention Description
    A diet plan with restricted calorie and carbohydrate intake
    Primary Outcome Measure Information:
    Title
    Change in BMI
    Time Frame
    baseline, 3 month
    Title
    Change in liver function biomarkers
    Description
    ALT, AST
    Time Frame
    baseline, 3 month
    Title
    Liver Stiffness Measurement
    Description
    LSM is suggested as degree of liver fibrosis
    Time Frame
    baseline, 3 month
    Title
    Fast Ultrasound Attenuation Parameter
    Description
    FAP is suggested as degree of liver steatosis.
    Time Frame
    baseline, 3 month
    Secondary Outcome Measure Information:
    Title
    Change in BMI
    Time Frame
    6 month, 12 month
    Title
    Change in liver function biomarkers
    Description
    ALT, AST
    Time Frame
    6 month, 12 month
    Title
    Change in blood pressure
    Time Frame
    baseline, 3 month
    Title
    Change in lipid
    Description
    triglyceride, total cholesterol , LDL-C, and HDL-C
    Time Frame
    baseline, 3 month
    Title
    Change in glycemic markers
    Description
    fasting glucose, fasting insulin, HbA1C
    Time Frame
    baseline, 3 month
    Title
    Change in body composition
    Description
    muscle mass, fat percentage
    Time Frame
    baseline, 3 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhong Liu
    Phone
    +86 13957104885
    Email
    liuzhongzheyi121@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhong Zhong, MD
    Organizational Affiliation
    First Affiliated Hospital of Zhejiang University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    35571881
    Citation
    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.
    Results Reference
    derived

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

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