UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027058
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

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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 or person

Institute

Nagoya University Hospital

Institute

Department

Personal name



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

名古屋大学医学部附属病院


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

2023 Year 10 Month 24 Day



Link to view the page

Value
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