Exploring the Mechanism of Dietary Pattern Improving MAFLD
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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 Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: leilei wang
- Phone Number: 0571-87783851
- Email: 2513118@zju.edu.cn
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: balanced diet
Carbohydrates 50% -65%, fats 20% -30%, and proteins 10% -15%.
|
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
|
|
Experimental: Low-carbohydrate diet
Carbohydrates 20% -40%, fats 30% -45%, and proteins 30% -40%.
|
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
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
0month and 12month
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: the second affiliated hospital of zhejiang university, Zhejiang University
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 20230683
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on NAFLD
-
NCT07241195RecruitingNAFLD and NASH | NAFLD( Non-alcoholic Fatty Liver Disease ) | NAFLD Cirrhosis
-
NCT03090347RecruitingNAFLD | Nutrient; Excess
-
NCT07093346RecruitingNAFLD | Nonalcoholic Fatty Liver Disease | Nonalcoholic Fatty Liver Disease (NAFLD) | NAFLD - Nonalcoholic Fatty Liver Disease | NAFLD (Non-alcoholic Fatty Liver Disease) | NAFLD (Nonalcoholic Fatty Liver Disease) | NAFLD - Non-Alcoholic Fatty Liver Disease | MASLD | Metabolic Dysfunction-Associated Steatotic Liver Disease | MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
-
NCT02918929Completed
-
NCT07518784RecruitingNAFLD | NAFLD (Nonalcoholic Fatty Liver Disease) | MASLD | MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
-
NCT03867487Not yet recruitingNAFLD | Non-Alcoholic Fatty Liver Disease | Pediatric NAFLD
Clinical Trials on Diet intervention
-
NCT06082921CompletedEating Behavior | Breast Feeding, Exclusive | Glycemic Response
-
NCT04315376CompletedObesity | Inflammatory Response | Exercise | Diet Habit | Abdominal Obesity
-
NCT05210023CompletedDyslipidemias | Overweight and Obesity
-
NCT03764579UnknownChildhood Obesity | Life Style | Circadian Rhythms
-
NCT03346486CompletedCognitive Performance | Physiological Stress | LDL Cholesterol
-
NCT04821076CompletedDiet; Deficiency | Exercise Intervention
-
NCT00592397CompletedCardiovascular Diseases | Obesity | Diabetes Mellitus
-
NCT04994938CompletedPhysical Activity | Diet Quality | Peer Leaders
-
NCT04761523RecruitingAcute Pancreatitis
-
NCT04337255Active, not recruitingStroke | Dementia | Alzheimer Disease | Dementia, Vascular | Cognitive Decline