Effect of Soluble dietary fiber on NAFLD Liver Disease

Phase 2

Recruiting

• Conditions: nonalcoholic fatty liver disease; fatty liver; K75.8.1

• Registration Number: JPRN-jRCTs031220714
• Lead Sponsor: Yoneda Masato

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-20
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

nonalcoholic fatty liver disease diagnosised by Evidence-based clinical practice guidelines for nonalcoholic fatty liver disease/nonalcoholic steatohepatitis 2020 and MRI-PDFF more than 3.5%

Exclusion Criteria

pregnant pateints, patients who is blest-feeding, patients who can't undergo MRI, patients allergic to this supplements

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum ALT levels before and after the end of treatment (12 weeks later) (6 g/day group, 18 g/day group)

Secondary Outcome Measures

Name	Time	Method
Serum AST before and after treatment (6 g/day group, 18 g/day group) before and after completion of treatment (12 weeks)<br>Serum gamma-GTP before and after treatment (6 g/day group, 18 g/day group) at the end of treatment (after 12 weeks)<br>MRI-PDFF values before and after treatment (6 g/day group and 18 g/day group) before and after the end of treatment (12 weeks)<br>Change in stool characteristics before and after administration (6 g/day group, 18 g/day group)<br>Comparison of ALT, AST, gamma-GTP, MRI-PDFF and stool characteristics change in different doses of SunFiber (6g/day group vs. 18g/day group)