The Effect of Vegetarian Diet on Patients With Metabolic Associated Fatty Liver Disease：A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- The primary outcome was the weight of fat mass after 24 weeks intervention.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinically diagnosed as fatty liver, and BMI≥24.0kg/m²;
- •18-60 years old;
- •Have not received drug treatment if having hyperglycemia, hyperlipidemia and high uric acid ;
- •No antibiotics in the last 1 month;
- •The guardian's informed consent;
Exclusion Criteria
- •Have received drug treatment of fatty liver disease within three months;
- •Patients with with liver cirrhosis, viral hepatitis and other liver diseases;
- •Patients with serious heart, lung, kidney diseases and patients with cancer;
- •Pregnant and nursing women;
- •Other conditions that may affect the results of the study
Arms & Interventions
Intervention group
Participations in this group are required to follow a healthy vegetarian diet （avoid meat, poultry, fish, dairy） during the 24-weeks trail.
Daily energy intake = BMR(basal metabolic rate) × 1.25-500kcal；BMR = 370 + 21.6 × Lean body mass(kg) Requirements of energy supply ratio: protein 15%-20%; fat 20%-25%; carbohydrate 50%-60%.
Intervention: dietary intervention (Behavioral)
Control group
Participations in this group are required to follow a healthy omnivorous diet (No restriction on food sources) during the 24-weeks trail.
Daily energy intake = BMR × 1.25-500kcal；BMR = 370 + 21.6 × Lean body mass(kg) Requirements of energy supply ratio: protein 15%-20%; fat 20%-25%; carbohydrate 50%-60%.
Intervention: dietary intervention (Behavioral)
Outcomes
Primary Outcomes
The primary outcome was the weight of fat mass after 24 weeks intervention.
Time Frame: 24 weeks
Weight loss, especially the reduction of body fat mass, is the most important treatment for the prevention and treatment of MAFLD and its complicationsIn our study, we will measure weight of fat mass using a body composition analyzer (Biospace Inbody 720, Korea) at the baseline and after 24-week intervention. The difference in the weight of fat mass after intervention between the two groups is the primary outcome.
Secondary Outcomes
- Results of B-ultrasonic examination and Fibroscan examination(24 weeks)
- The changes of serum alanine aminotransferase (ALT) at week 24 intervention from the baseline(24 weeks)
- The changes of serum aspartate aminotransferase (AST) at week 24 intervention from the baseline(24 weeks)
- 24-week weight change(24 weeks)