Clinical trial NCT03972631: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Obesity
Keywords: Lifestyle interventions
Low-carbohydrate diet
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in BMI
timeFrame: baseline, 3 month
measure: Change in liver function biomarkers
timeFrame: baseline, 3 month
measure: Liver Stiffness Measurement
timeFrame: baseline, 3 month
measure: Fast Ultrasound Attenuation Parameter
timeFrame: baseline, 3 month
Secondary outcomes:
measure: Change in BMI
timeFrame: 6 month, 12 month
measure: Change in liver function biomarkers
timeFrame: 6 month, 12 month
measure: Change in blood pressure
timeFrame: baseline, 3 month
measure: Change in lipid
timeFrame: baseline, 3 month
measure: Change in glycemic markers
timeFrame: baseline, 3 month
measure: Change in body composition
timeFrame: baseline, 3 month
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: Zhong Zhong, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.