Impact of a vegetarian diet on fatty liver disease
The Effect of Vegetarian Diet on Patients With Metabolic Associated Fatty Liver Disease：A Randomized Clinical Trial
NA · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · NCT05443581
This study is testing if a vegetarian diet can help people with fatty liver disease improve their health compared to a regular diet over 24 weeks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (other) |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05443581 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of a vegetarian diet on patients diagnosed with metabolic associated fatty liver disease (MAFLD). Participants aged 18-60 will be randomly assigned to either a healthy vegetarian diet or a healthy omnivorous diet for a duration of 24 weeks. The study will assess various outcomes, including fat mass, liver function, and metabolic parameters, through clinical evaluations and dietary compliance monitoring conducted by professional dietitians. The goal is to determine if a vegetarian diet can serve as an effective nutritional intervention for MAFLD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with a clinical diagnosis of fatty liver and a BMI of 24.0 kg/m² or higher.
Not a fit: Patients with liver cirrhosis, viral hepatitis, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a dietary approach to effectively manage and improve metabolic associated fatty liver disease.
How similar studies have performed: Previous studies have indicated dietary interventions can improve metabolic conditions, suggesting potential success for this approach, though the specific vegetarian diet focus is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai
- Department of Clinical Nutrition, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (RECRUITING)
Study contacts
- Study coordinator: Xiuhua Shen, Professor
- Email: srachel@126.com
- Phone: +86-139-1691-0428
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metabolism and Nutrition Disorder, Liver Diseases, Obesity, Diet, Healthy, Metabolism associated fatty liver disease, Vegetarian diet, diet intervention