Unique ID issued by UMIN | UMIN000027058 |
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Receipt number | R000030944 |
Scientific Title | Usefulness of kestose for the patients with NAFLD and NASH |
Date of disclosure of the study information | 2017/04/27 |
Last modified on | 2023/10/24 00:46:50 |
Usefulness of kestose for the patients with NAFLD and NASH
Treatment with kestose for NAFLD/NASH
Usefulness of kestose for the patients with NAFLD and NASH
Treatment with kestose for NAFLD/NASH
Japan |
Nonalcoholic fatty liver disease/Nonalcoholic steatohepatitis
Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism | Vascular surgery |
Others
NO
To evaluate the efficacy of kestose in the patients with NAFLD/NASH
Efficacy
Improvement of liver enzyme
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
Central registration
2
Treatment
Food |
kestose
placebo
20 | years-old | <= |
Not applicable |
Male and Female
Patients diagnosed as NAFLD/NASH
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
60
1st name | Takashi |
Middle name | |
Last name | Honda |
Nagoya University Hospital
Department of Gastroenterology and Hepatology
466-8560
65, Tsuruma-cho, Showa-ku, Nagoya
+81-52-744-2169
honda@med.nagoya-u.ac.jp
1st name | Takashi |
Middle name | |
Last name | Honda |
Nagoya University Hospital
Department of Gastroenterology and Hepatology
466-8560
65, Tsuruma-cho, Showa-ku, Nagoya
+81-52-744-2169
honda@med.nagoya-u.ac.jp
Nagoya University Hospital
B Food Science Co.Ltd.
Profit organization
Nagoya university hospital Ethical Review Committee
65, Tsuruma-cho, Showa-ku, Nagoya
052-744-2423
ethics@med.nagoya-u.ac.jp
NO
名古屋大学医学部附属病院
2017 | Year | 04 | Month | 27 | Day |
Unpublished
Open public recruiting
2017 | Year | 02 | Month | 17 | Day |
2017 | Year | 06 | Month | 02 | Day |
2017 | Year | 06 | Month | 03 | Day |
2027 | Year | 03 | Month | 30 | Day |
2017 | Year | 04 | Month | 18 | Day |
2023 | Year | 10 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030944
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