Exploring the Mechanism of Dietary Pattern Improving MAFLD

NCT05960396 | Unknown

• 1 other identifier: 20230683
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

NAFLD; Diet Habit

Outcome Measures

Primary Outcomes (1)

• 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)

  0month and 12month

Study Arms (2)

balanced diet

EXPERIMENTAL

Carbohydrates 50% -65%, fats 20% -30%, and proteins 10% -15%.

Behavioral: Diet intervention

Low-carbohydrate diet

EXPERIMENTAL

Carbohydrates 20% -40%, fats 30% -45%, and proteins 30% -40%.

Behavioral: Diet intervention

Interventions

Diet intervention BEHAVIORAL

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

Low-carbohydrate diet; balanced diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Feeding Behavior

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Behavior, Animal; Behavior

Study Officials

• the second affiliated hospital of zhejiang university

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

leilei wang

CONTACT

0571-87783851; 2513118@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 25, 2023
• Study Start: September 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: December 30, 2025
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share