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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027058
Receipt No. 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 2019/10/29

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Basic information
Public title Usefulness of kestose for the patients with NAFLD and NASH
Acronym Treatment with kestose for NAFLD/NASH
Scientific Title Usefulness of kestose for the patients with NAFLD and NASH
Scientific Title:Acronym Treatment with kestose for NAFLD/NASH
Region
Japan

Condition
Condition Nonalcoholic fatty liver disease/Nonalcoholic steatohepatitis
Classification by specialty
Hepato-biliary-pancreatic medicine Endocrinology and Metabolism Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of kestose in the patients with NAFLD/NASH
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of liver enzyme
Key secondary outcomes 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











Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 kestose
Interventions/Control_2 placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients diagnosed as NAFLD/NASH
Key exclusion 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
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Honda
Organization Nagoya University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 466-8560
Address 65, Tsuruma-cho, Showa-ku, Nagoya
TEL +81-52-744-2169
Email honda@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Honda
Organization Nagoya University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 466-8560
Address 65, Tsuruma-cho, Showa-ku, Nagoya
TEL +81-52-744-2169
Homepage URL
Email honda@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization B Food Science Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya university hospital Ethical Review Committee
Address 65, Tsuruma-cho, Showa-ku, Nagoya
Tel 052-744-2423
Email ethics@med.nagoya-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 02 Month 17 Day
Date of IRB
2017 Year 06 Month 02 Day
Anticipated trial start date
2017 Year 06 Month 03 Day
Last follow-up date
2027 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 18 Day
Last modified on
2019 Year 10 Month 29 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030944

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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