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

Phase 3

Recruiting

• Conditions: Patients with fatty liver associated with metabolic dysfunction (MAFLD)

• Registration Number: JPRN-jRCTs051230187
• Lead Sponsor: Takahashi Michiko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-22
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.