Trial to verify the improvement of fatty liver with brown rice supplements

JRCT ID: jRCTs051230187

Registered date:22/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with fatty liver associated with metabolic dysfunction (MAFLD)
• Date of first enrollment: 22/02/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): 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 duration of diet and exercise therapy (less than/above 3 months). Participants will be allocated in a 1:1 ratio to the brown rice supplement group and the placebo group. Administration Method: Take 1 packet once a day, twice daily, for 12 weeks.

Outcome(s)

• Primary Outcome: 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 Outcome

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 after the initiation of test food intake.
4. Changes in blood amino acid analysis and pentosidine from the start of test food intake to 12 weeks after.
5. Additional measurements may be conducted for items deemed necessary with the advancement of scientific knowledge in the future.

Safety Evaluation Criteria
Presence or absence of gastrointestinal disorders
Presence or absence of other illnesses or conditions

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Takahashi Michiko