Clinical trial NCT05443581: The Effect of Vegetarian Diet on Patients With Metabolic Associated Fatty Liver Disease
Official title: The Effect of Vegetarian Diet on Patients With Metabolic Associated Fatty Liver Disease：A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolism and Nutrition Disorder
Liver Diseases
Obesity
Diet, Healthy
Keywords: Metabolism associated fatty liver disease
Obesity
Vegetarian diet
diet intervention
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, 18-60 years old patients with metabolic associated fatty liver disease（MAFLD） will be recruited to test the intervention effect of vegetarian diet. This randomized clinical trial randomized individuals to a healthy vegetarian diet or a healthy omnivorous diet for 24 weeks. At the baseline and after the 24week intervention, the clinical manifestations of MAFLD, obesity levels, indices for glucose and lipid metabolism parameters, results of questionnaire and fecal samples will be collected and analyzed.

Detailed description: Dietary control remains an important way for nutritional intervention of metabolic related fatty liver disease. However, studies shows that patients have low compliance to the traditional diet. The topic proposed based on previous studies，recruiting of 220 obesity patients with metabolic associated fatty liver disease aged 18-60. After the informed consent, they will be randomly divided into intervention group and control group, intervention group will be given healthy vegetarian diet intervention and the control group given healthy omnivorous diet. Both diets are in line with the principles of fatty liver treatment. Interventions consisted primarily of face-to -face interview monthly and online interview every 2 weeks, which will be performed by professional dietitians. All participants were asked not to alter their exercise patterns during the study period. The primary outcome was the weight of fat mass after 24 weeks intervention. Secondary outcomes included imaging findings (B-ultrasonic examination and Fibroscan) of MAFLD, liver function, anthropometric measures, plasma lipid and glucose levels. At the meantime, serum oxidative stress indices, results of compliance survey and metabolites of Intestinal flora will be collected and analyzed. Through the above detection of the indicators related to MAFLD and obesity, it is explored whether the vegetarian diet can be an efficient and feasible way to the nutritional therapy of MAFLD.

Eligibility criteria: Inclusion Criteria:

1. Clinically diagnosed as fatty liver, and BMI≥24.0kg/m²;
2. 18-60 years old;
3. Have not received drug treatment if having hyperglycemia, hyperlipidemia and high uric acid ;
4. No antibiotics in the last 1 month;
5. The guardian's informed consent;

Exclusion Criteria:

1. Have received drug treatment of fatty liver disease within three months;
2. Patients with with liver cirrhosis, viral hepatitis and other liver diseases;
3. Patients with serious heart, lung, kidney diseases and patients with cancer;
4. Pregnant and nursing women;
5. Other conditions that may affect the results of the study

Primary outcomes:
measure: The primary outcome was the weight of fat mass after 24 weeks intervention.
timeFrame: 24 weeks
Secondary outcomes:
measure: Results of B-ultrasonic examination and Fibroscan examination
timeFrame: 24 weeks
measure: The changes of serum alanine aminotransferase (ALT) at week 24 intervention from the baseline
timeFrame: 24 weeks
measure: The changes of serum aspartate aminotransferase (AST) at week 24 intervention from the baseline
timeFrame: 24 weeks
measure: 24-week weight change
timeFrame: 24 weeks
Other outcomes:
measure: The Results of compliance survey will be collected every month.
timeFrame: 24 weeks
measure: The difference of serum superoxide dismutase (SOD) level between two groups after 24-week intervention
timeFrame: 24 weeks
measure: The difference of metabolites of Intestinal flora between two groups after 24-week intervention.
timeFrame: 24 weeks
Locations:
city: Shanghai
country: China
facility: Department of Clinical Nutrition, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Xinhua Hospital Afflicated to Shanghai Jiaotong University of Medicin
name: Xiuhua Shen, Professor
role: STUDY_CHAIR
References: