Metabolism and Nutrition DisorderNCT05443581
The Effect of Vegetarian Diet on Patients With Metabolic Associated Fatty Liver Disease
A study testing dietary intervention in people with Metabolism and Nutrition Disorder and Liver Diseases, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Metabolism and Nutrition Disorder, Liver Diseases, Obesity
- What is being tested?
- dietary intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Clinical Nutrition, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Xiuhua Shen, Doctor, 13916910428, srachel@126.com
About this study
Official title: The Effect of Vegetarian Diet on Patients With Metabolic Associated Fatty Liver Disease：A Randomized Clinical Trial
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.
Read the 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.
- Being tested
- dietary intervention
- Keywords
- Metabolism associated fatty liver disease, Obesity, Vegetarian diet, diet intervention
- Medical subject headings
- Nutrition Disorders, Liver Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: 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%. Receives: Behavioral: dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (4)
Results of B-ultrasonic examination and Fibroscan examination
Imaging examination results are an important basis for the clinical diagnosis of NAFLD, which can show the degree of hepatic steatosis and hepatic fibrosis. Imaging findings of MAFLD will be measured and compared at the baseline and end of our study.
Measured: 24 weeks
The changes of serum alanine aminotransferase (ALT) at week 24 intervention from the baseline
Hepatic steatosis is often accompanied by changes in hepatic enzymes.
Measured: 24 weeks
The changes of serum aspartate aminotransferase (AST) at week 24 intervention from the baseline
Hepatic steatosis is often accompanied by changes in hepatic enzymes.
Measured: 24 weeks
24-week weight change
The 24-week intervention is expected to bring weight loss. We will compare the weight loss between the two groups
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Jul 2022
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolism and Nutrition DisorderStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiuhua Shen, Professor, Study chair, Xinhua Hospital Afflicated to Shanghai Jiaotong University of Medicin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443581
- Sponsor's protocol ID
- XH-22-004
- Status last verified
- Nov 2023
- First submitted
- 23 May 2022
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vegetarian Diet on Patients With Metabolic Associated Fatty Liver Disease：A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05443581
- Acronym / sponsor ID
- XH-22-004
- Keywords
- Metabolism associated fatty liver disease, Obesity, Vegetarian diet, diet intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: dietary interventionParticipations 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%. |
| Control group | Active comparator | Behavioral: dietary interventionParticipations 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%. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary interventionDietary guidance will be given to participants through monthly face-to-face interviews and biweekly telephone calls to change their dietary structure and energy intake. | Behavioural | Control group, Intervention group |
Primary outcome
The primary outcome was the weight of fat mass after 24 weeks intervention.
Time frame: 24 weeks
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.
4 secondary outcomes
Results of B-ultrasonic examination and Fibroscan examination
Time frame: 24 weeks
The changes of serum alanine aminotransferase (ALT) at week 24 intervention from the baseline
Time frame: 24 weeks
The changes of serum aspartate aminotransferase (AST) at week 24 intervention from the baseline
Time frame: 24 weeks
24-week weight change
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiuhua Shen, Professor study chair
Xinhua Hospital Afflicated to Shanghai Jiaotong University of Medicin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary intervention in people with Metabolism and Nutrition Disorder and Liver Diseases, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiuhua Shen, Professor (+86-139-1691-0428, srachel@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was the weight of fat mass after 24 weeks intervention. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.