Placebo-controlled, double-blind, randomized controlled trial to verify the improvement of fatty liver with brown rice supplements in patients with Fatty liver associated with metabolic dysfunction (MAFLD)

Takahashi Michiko0 个研究点目标入组 60 人开始时间: 2024年2月22日最近更新: 2024年5月27日

试验速览

暂无简介。

•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.

•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.

发起方

Takahashi Michiko