Effect of Soluble dietary fiber on NAFLD Liver Disease

JRCT ID: jRCTs031220714

Registered date:20/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: nonalcoholic fatty liver disease
• Date of first enrollment: 07/08/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): soluble dietary fibrer

Outcome(s)

• Primary Outcome: Serum ALT levels before and after the end of treatment (12 weeks later) (6 g/day group, 18 g/day group)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include 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%
• Exclude criteria: pregnant pateints, patients who is blest-feeding, patients who can't undergo MRI, patients allergic to this supplements

Related Information

• Primary Sponsor: Yoneda Masato