Patients with fatty liver associated with metabolic dysfunction (MAFLD)
Conditions
Interventions
Randomized Assignment: Randomized block allocation will be conducted, stratifying by CAP (Controlled Attenuation Parameter) below/above 280 dB/m before intake, presence of diabetes complications, and
Sponsors
Takahashi Michiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients meeting one of the following criteria in accordance with the diagnostic criteria of MAFLD (1) Type 2 diabetes (HbA1c <= 9%) (2) Overweight or obese patients with a BMI of 23 kg/m2 or higher If undergoing pharmacotherapy for diabetes or obesity, they must have been consistently taking the same medication, dosage, and administration for at least 12 weeks prior to the start of the test food intake. (3) Individuals with a BMI less than 23 kg/m2 and two or more of the following metabolic abnormalities, or those undergoing pharmacotherapy for hypertension or lipid disorders Abdominal circumference of 90 cm or more for males and 80 cm or more for females Systolic blood pressure of 130 mmHg or higher or diastolic blood pressure of 80 mmHg or higher Serum triglycerides of 150 mg/dL or higher Serum HDL cholesterol less than 40 mg/dL for males and less than 50 mg/dL for females Impaired glucose tolerance (fasting blood glucose 110-125 mg/dL, 75g OGTT 2-hour value 140-199 mg/dL, or HbA1c 5.7-6.4%) HOMA-IR 2.5 or higher 2. Gender-neutral, age: 18 years or older at the time of obtaining consent 3. Diagnosis of fatty liver: Individuals with a CAP (Controlled Attenuation Parameter) measurement value of 230 dB/m or higher using ultrasound attenuation measurement with FibroScan. 4. Individuals who have provided written consent of their own free will for participation in this clinical study.
Exclusion criteria
Exclusion criteria: 1.Individuals who have undergone cancer treatment within the past 5 years. 2.Individuals with allergies to rice or starch. 3.Pregnant individuals. 4.Individuals with implanted devices in their bodies. 5.Others whom the principal investigator or participating physicians deemed unsuitable for this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in Controlled Attenuation Parameter (CAP) values for liver fat measurement using FibroScan, comparing the state of fatty liver before and 12 weeks after the initiation of the test food intake. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Evaluation Criteria 1. Percentage change in Controlled Attenuation Parameter (CAP) values for liver fat measurement before and 12 weeks after the initiation of test food intake. 2. Change in liver stiffness measurement (LSM) values and percentage change before and 12 weeks after the initiation of test food intake. 3. Change and percentage change in FAST score (a score derived from liver fat CAP, liver stiffness VCTE, and AST measured by FibroScan). 4. Change and percentage change in blood test data (BUN, Cr, eGFR, AST, ALT, gGTP, ChE, ferritin, HbA1c, GA, blood glucose, IRI, HOMA-R, TG, T-chol, HDL, LDL, UA), and FIB-4 index (a scoring system indicating the degree of liver fibrosis, age * AST (U/L) / platelet count * RouteALT (U/L)), excluding IRI and HOMA-R in case of insulin therapy. 5. Change and percentage change in waist circumference, waist-hip ratio, weight, BMI, and waist-to-height ratio before and 6 / 12 weeks after the initiation of test food intake. 6. Change and percentage change in muscle mass, body fat mass, and phase angle measured by Bioelectrical Impedance Analysis (BIA) before and 6 / 12 weeks after the initiation of test food intake. 7. Change and percentage change in systolic and diastolic blood pressure from the start of test food intake to 6 / 12 weeks after. 8. Changes in Quality of Life (QOL) assessments (SF12, Anti-Aging QOL Common Questionnaire). 9. Changes in dietary preferences, including the food frequency questionnaire based on food groups (FFQg) and daily alcohol intake. 10. Changes in physical activity assessment using the Global Physical Activity Questionnaire (GPAQ). Exploratory Evaluation Criteria 1. Changes in the gut microbiota before and 12 weeks after the initiation of test food intake. 2. Changes in serum adipokines (adiponectin, leptin, chemerin) before and 12 weeks after the initiation of test food intake, including the change in quantity and percentage change. 3. Changes in lipid mediators before and 12 weeks afte | — |
Contacts
Public ContactTomoko Yamada
Kobe University Hospital
Outcome results
None listed