Usefulness of kestose for the patients with NAFLD and NASH

JRCT ID: jRCTs041180162

Registered date:29/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: NAFLD/NASH
• Date of first enrollment: 16/01/2017
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Arm A: Kestose(10g) every day for 8 weeks
Arm B: Maltose (5g) every day for 8 weeks

Outcome(s)

• Primary Outcome: Improvement of liver enzyme

Secondary Outcome

1.Changes of short-chain fatty acid (Butyric acid,Acetic acid,Propionic acid etc.)
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.)
3.Changes of hepatic fibrosis markers
4.Changes of degree of fatty liver by abdominal ultrasound examination
5.Correlation of gut microbiota and therapeutic effect
6.Changes of body weight and BMI
7.Metabolome and protein analysis of metabolite in feces
8.Changes of bile acid
9.Correlation between expiratory noble gases, gut microbiota
and NAFLD/NASH
10.Correlation between usefulness of kestose and disease prognosis in the patients with NAFLD/NASH

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients diagnosed as NAFLD/NASH

Exclude criteria

1.Women with pregnancy or possible pregnancy
2.Patients with severe renal failure and heart failure
3.Patient who is considered to be inappropriate for entry into the trial by the investigator
4.Medical doctors decided the patients are inappropriate.
5.Patients with substantial alcohol consumption (20g/day for women or >30g/day for men).
6.Patients with poor glycemic control (HbA1c>9.0%)
7.Patients with other active hepatitis and hepatocellular carcinoma
8.Patients with history of gastrointestinal surgery
9.Patients who take nonabsorbable antibiotic

Related Information

• Primary Sponsor: Honda Takashi
• Source(s) of Monetary Support: B Food Science Co., Ltd.