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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
China
Department of Clinical Nutrition, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Xiuhua Shen, Professor
srachel@126.com
+86-139-1691-0428
Backup
Kaijie Xu, Master
kaijie111xu@126.com
+86-150-2668-6958
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2024-05
Participants
Target number of participants: 220
Treatments
Experimental: 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%.
Active_comparator: 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%.
Sponsors
Leads: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov