The Effect of Vegetarian Diet on Patients With Metabolic Associated Fatty Liver Disease

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Metabolism and Nutrition Disorder; Obesity; Diet, Healthy; Liver Diseases

Treatments: Behavioral: dietary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05443581

XH-22-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

Intervention group

Experimental group

Description:

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%.

Treatment:

Behavioral: dietary intervention

Control group

Active Comparator group

Description:

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%.

Treatment:

Behavioral: dietary intervention