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

NCT ID: NCT05443581

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-05-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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%.

Group Type: EXPERIMENTAL

dietary intervention

Intervention Type: BEHAVIORAL

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.

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%.

Group Type: ACTIVE_COMPARATOR

dietary intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiuhua Shen, Professor

Role: STUDY_CHAIR

Xinhua Hospital Afflicated to Shanghai Jiaotong University of Medicin

Locations

Department of Clinical Nutrition, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiuhua Shen, Professor

Role: CONTACT

srachel@126.com

+86-139-1691-0428

Kaijie Xu, Master

Role: CONTACT

kaijie111xu@126.com

+86-150-2668-6958

Facility Contacts

Xiuhua Shen, Doctor

Role: primary

srachel@126.com

13916910428

Other Identifiers

XH-22-004

Identifier Type: -

Identifier Source: org_study_id