Oligonol and its beneficial effects in fatty liver disease

Phase 3

Completed

• Conditions: on- alcoholic fatty liver disease; Non- Oligonol

• Registration Number: TCTR20200814001
• Lead Sponsor: AHCC (Thailand) co. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-01-01
• Study Start: 2020-08-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Adults aged 18 years and older with NAFLD were enrolled in the study. NAFLD was defined by elevated ALT (ALT ≥19 U/L in women and ≥30 U/L in men) with the presence of hepatic steatosis grade ≥2 (defined as liver fat content ≥11% by MRI-PDFF).

Exclusion Criteria

(1) cirrhosis defined by cirrhotic configuration on liver imaging or liver stiffness score ≥ 10.3 kPa on transient elastography
(2) liver decompensation (defined by history of bleeding varices, ascites, and encephalopathy)
(3) hepatocellular carcinoma
(4) daily alcohol drinking >30 g in men, 20 g in women
(5) other known chronic liver diseases, such as chronic hepatitis B, chronic hepatitis C, autoimmune hepatitis, primary biliary cholangitis, hemochromatosis, and Wilson disease
(6) pregnancy
(7) history of lychee allergy
(8) chronic kidney disease stage 3 and above (calculated glomerular filtration rate <60 mL/min).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the reduction of hepatic fat content 6 months after the initiation of Oligonol Magnetic resonance imaging with proton density fat fraction

Secondary Outcome Measures

Name	Time	Method
The improvement of metabolic syndrome 6 months after the initiation of Oligonol body mass index, blood pressure, insulin resistance, and serum lipids ,The reduction in oxidative stress, inflammation and apoptosis 6 months after the initiation of Oligonol Serum cytokerarin-18 fragment, Malondialdehyde