NAFLDNCT05960396
Exploring the Mechanism of Dietary Pattern Improving MAFLD
A study testing Diet intervention in people with NAFLD and Diet Habit, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
investigators plan to observe the changes of biochemical indicators, body composition, gut microbiota, metabolomics in patients at different periods through balanced diet and Low-carbohydrate diet, so as to determine the beneficial "intestinal functional group" of MAFLD, and provide basis for the selection of the best… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- NAFLD, Diet Habit
- What is being tested?
- Diet intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 30 Dec 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years old, Han nationality, residing in China ；
- MRI-PDFF ≥ 5% or /and control attenuation index (CAP value) ≥ 244db /m and Alanine transaminase or /and cereal grass Transaminase are within 3 times of the upper limit of normal value;
- At least one metabolic disease exists: BMI ≥ 24kg/m2; According to widely recognized international standards, it is diagnosed as type 2 diabetes [diabetes symptoms+plasma glucose level at any time ≥ 200mg /dl (11.1mmol /L) or fasting plasma glucose ≥ 126mg /dl (7.0mmol /L) or in Oral Glucose Tolerance Test test, blood glucose at 2 hours after meal ≥ 200mg /dl (11.1mmol /L)]; There are at least two risk factors for metabolic abnormalities: a Waist circumference: male ≥ 90cm, female ≥ 80cm; B Blood pressure ≥ 130/85mmHg or receiving specific drug treatment; C Plasma triglycerides ≥ 150mg/dl (≥ 1.70mmol/L) or receiving specific drug treatment; D Plasma High-density lipoprotein cholesterol: male\<40mg /dl (\<1.0mmol /L) and female\<50mg /dl (\<1.3mmol /L) or receive specific drug treatment; E Pre diabetes [i.e. Glucose test#Fasting blood sugar level is 100~125mg /dl (5.6~6.9 mmol /L), or blood glucose level 2 hours after meal is 140~199mg /dl (7.8~11.0 mmol /L) or Glycated hemoglobin is 5.7%~6.4% (39~47 mmol /L)]; F steady-state model evaluation - insulin resistance index ≥ 2.5; The plasma level of hypersensitive C-reactive protein is ≥ 2mg/L.
- Willing to accept evaluation and sign informed consent
Who cannot join
- Fatty liver patients undergoing medication treatment;
- Those who have received weight loss treatment such as medication, surgery, or meal replacement within the past 3 months;
- Those who currently or in the past 3 weeks have taken antibiotics, probiotics, prebiotics or other microbiota related supplements;
- Receive Corticosteroid or Thyroid hormones treatment; ⑤ Having clinically diagnosed viral hepatitis, autoimmune liver disease, cirrhosis and other liver diseases
- Secondary obesity caused by endocrine, genetic, metabolic and Central nervous system disease; ⑦ Patients with abnormal liver function (Alanine transaminase or /and glutamic oxalic Transaminase exceed the upper limit of normal value by 3 times); Patients with renal dysfunction (serum creatinine exceeding the upper limit of normal values); Suffering from diseases such as kidney disease that require protein intake control;
- Diseases affecting food digestion and absorption (such as chronic diarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinal ulcer, postoperative gastrointestinal tract resection, Cholecystitis /cholecystectomy, etc.); ⑨ Suffering from cardio cerebral Vascular disease, grade 3 hypertension, chronic hepatitis, malignant tumor, anemia, mental disease, memory impairment, epilepsy and other diseases ⑩ having major diseases or having recently undergone Major trauma /surgery, etc
Trial locations and contacts
No sites are listed yet.
About this study
investigators plan to observe the changes of biochemical indicators, body composition, gut microbiota, metabolomics in patients at different periods through balanced diet and Low-carbohydrate diet, so as to determine the beneficial "intestinal functional group" of MAFLD, and provide basis for the selection of the best time for probiotics and fecal bacteria transplantation.By comparing the response of the main outcome indicators to the two dietary structures, personalized nutritional intervention measures can be achieved.
Read the detailed description
- Balanced diet group: carbohydrates 50% -65%, fats 20% -30%, and proteins 10% -15%, among which proteins mainly come from beans, soy products, nuts, milk, poultry meat, aquatic products, and animal meat (lean); Lipids mainly come from Unsaturated fat acids, reducing the intake of Saturated fat acids; Carbohydrates mainly come from staple foods, with a combination of coarse and fine staple foods；
- Low-carbohydrate diet intervention : carbohydrate 20% -40%, fat 30% -45%, protein 30% -40%. The protein mainly comes from beans, soy products, nuts, milk, meat, etc; Lipids mainly come from Unsaturated fat acids, reducing the intake of Saturated fat acids; Carbohydrates mainly come from low GI foods.
- Conditions
- NAFLD, Diet Habit
- Being tested
- Diet intervention
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet interventionBehavioural
investigators use different diet intervention to observe the changes of biochemical indicators, body composition, Gut microbiota, metabonomics, etc. for patients with MAFLD during different periods
| Study group | Role | What they receive |
|---|---|---|
| balanced diet | Experimental | Carbohydrates 50% -65%, fats 20% -30%, and proteins 10% -15%. Receives: Behavioral: Diet intervention |
| Low-carbohydrate diet | Experimental | Carbohydrates 20% -40%, fats 30% -45%, and proteins 30% -40%. Receives: Behavioral: Diet intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of liver fat content before and after interventions
Measurement of liver fat content was undertaken at baseline and at the end of the study by using proton magnetic resonance spectroscopy (MRS)
Measured: 0month and 12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- the second affiliated hospital of zhejiang university, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960396
- Sponsor's protocol ID
- 20230683
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 25 Jul 2023
- Results posted
- 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 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Mechanism of Dietary Pattern Improving MAFLD
- ClinicalTrials.gov ID
- NCT05960396
- Acronym / sponsor ID
- 20230683
- Conditions
- NAFLD, Diet Habit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 25 Jul 2023 (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.
investigators plan to observe the changes of biochemical indicators, body composition, gut microbiota, metabolomics in patients at different periods through balanced diet and Low-carbohydrate diet, so as to determine the beneficial "intestinal functional group" of MAFLD, and provide basis for the selection of the best time for probiotics and fecal bacteria transplantation.By comparing the response of the main outcome indicators to the two dietary structures, personalized nutritional intervention measures can be achieved.
Detailed description
- Balanced diet group: carbohydrates 50% -65%, fats 20% -30%, and proteins 10% -15%, among which proteins mainly come from beans, soy products, nuts, milk, poultry meat, aquatic products, and animal meat (lean); Lipids mainly come from Unsaturated fat acids, reducing the intake of Saturated fat acids; Carbohydrates mainly come from staple foods, with a combination of coarse and fine staple foods；
- Low-carbohydrate diet intervention : carbohydrate 20% -40%, fat 30% -45%, protein 30% -40%. The protein mainly comes from beans, soy products, nuts, milk, meat, etc; Lipids mainly come from Unsaturated fat acids, reducing the intake of Saturated fat acids; Carbohydrates mainly come from low GI foods.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| balanced diet | Experimental | Behavioral: Diet interventionCarbohydrates 50% -65%, fats 20% -30%, and proteins 10% -15%. |
| Low-carbohydrate diet | Experimental | Behavioral: Diet interventionCarbohydrates 20% -40%, fats 30% -45%, and proteins 30% -40%. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years old, Han nationality, residing in China ；
Key exclusion criteria (6 listed)
- Fatty liver patients undergoing medication treatment;
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 |
|---|---|---|
| Diet interventioninvestigators use different diet intervention to observe the changes of biochemical indicators, body composition, Gut microbiota, metabonomics, etc. for patients with MAFLD during different periods | Behavioural | Low-carbohydrate diet, balanced diet |
Primary outcome
changes of liver fat content before and after interventions
Time frame: 0month and 12month
Measurement of liver fat content was undertaken at baseline and at the end of the study by using proton magnetic resonance spectroscopy (MRS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for NAFLD
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Rupatadine in the Treatment of Nonalcoholic Fatty Liver Disease Patients.
NAFLD (Nonalcoholic Fatty Liver Disease)
Not yet recruitingPhase 2
Qurse Revand for MASLD: A Randomized Controlled Safety and Efficacy Trial
MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
RecruitingPhase 2
Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
Non-Alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease
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.
the second affiliated hospital of zhejiang university principal investigator
Zhejiang University
Questions about this trial
What is this clinical trial studying?
A study testing Diet intervention in people with NAFLD and Diet Habit, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 4 inclusion and 6 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 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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 leilei wang (0571-87783851, 2513118@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of liver fat content before and after interventions (time frame: 0month and 12month). 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 25 Jul 2023.