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

NCT05443581 | Unknown

• 1 other identifier: XH-22-004
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Metabolism associated fatty liver disease; Obesity; Vegetarian diet; diet intervention

Outcome Measures

Primary Outcomes (1)

• The primary outcome was the weight of fat mass after 24 weeks intervention.

  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.

  24 weeks

Secondary Outcomes (4)

• 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

Other Outcomes (3)

• The Results of compliance survey will be collected every month.

  24 weeks

• The difference of serum superoxide dismutase (SOD) level between two groups after 24-week intervention

  24 weeks

• The difference of metabolites of Intestinal flora between two groups after 24-week intervention.

  24 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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%.

Behavioral: dietary intervention

Control group

ACTIVE COMPARATOR

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%.

Behavioral: dietary intervention

Interventions

dietary intervention 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; Intervention group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinically diagnosed as fatty liver, and BMI≥24.0kg/m²;
• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Nutrition Disorders; Liver Diseases; Obesity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Digestive System Diseases; Overweight; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Xiuhua Shen, Professor

  Xinhua Hospital Afflicated to Shanghai Jiaotong University of Medicin

  STUDY CHAIR

Central Study Contacts

Xiuhua Shen, Professor

CONTACT

+86-139-1691-0428; srachel@126.com

Kaijie Xu, Master

CONTACT

+86-150-2668-6958; kaijie111xu@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: July 5, 2022
• Study Start: July 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 14, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)