Clinical Trial Details

Trial ID: L0471
Source ID: JPRN-jRCTs041180162
Associated Drug: Kestose
Title: Usefulness of kestose for the patients with NAFLD and NASH
Acronym: --
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: NAFLD/NASH
Interventions: Arm A: Kestose(10g) every day for 8 weeks<br>Arm B: Maltose (5g) every day for 8 weeks
Outcome Measures: Improvement of liver enzyme1.Changes of short-chain fatty acid (Butyric acid,Acetic acid,Propionic acid etc.) <br>2.Changes of pathologic and metabolic marker (HOMA-IR, NAFIC socre, NAFLD fibrosis sore, FIB-4 index, APRI index, T.Cho, LDL-Cho, HDL-Cho, TG, FFA, ferritin, fasting glucose,HbA1c, high sensitivity CRP etc.) <br>3.Changes of hepatic fibrosis markers <br>4.Changes of degree of fatty liver by abdominal ultrasound examination <br>5.Correlation of gut microbiota and therapeutic effect <br>6.Changes of body weight and BMI <br>7.Metabolome and protein analysis of metabolite in feces <br>8.Changes of bile acid <br>9.Correlation between expiratory noble gases, gut microbiota<br>and NAFLD/NASH <br>10.Correlation between usefulness of kestose and disease prognosis in the patients with NAFLD/NASH
Sponsor/Collaborators: Honda Takashi
Gender: All
Age: >= 20age oldNot applicable
Phases: Not applicable
Enrollment: 60
Study Type: Interventional
Study Designs: randomized controlled trial, double blind, placebo control, parallel assignment, treatment purpose
Start Date: 29/03/2019
Completion Date: --
Results First Posted: --
Last Update Posted: 10 January 2022
Locations: Japan
URL: https://jrct.niph.go.jp/latest-detail/jRCTs041180162