NCT05443581

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

The Effect of Vegetarian Diet on Patients With Metabolic Associated Fatty Liver Disease：A Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metabolism and Nutrition Disorder
• Liver Diseases
• Obesity
• Diet, Healthy

Interventions

Type	Name	Description
BEHAVIORAL	dietary intervention	Dietary guidance will be given to participants through monthly face-to-face interviews and biweekly telephone calls to change their dietary structure and energy intake.

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2022-07-05
• Last updated: 2024-05-14

Locations

1 site across 1 country: China