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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027503
Receipt No. R000031286
Scientific Title A clinical study for evaluating the effects of maltitol on improving liver function
Date of disclosure of the study information 2018/09/30
Last modified on 2019/05/30

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Basic information
Public title A clinical study for evaluating the effects of maltitol on improving liver function
Acronym A clinical study for evaluating the effects of maltitol on improving liver function
Scientific Title A clinical study for evaluating the effects of maltitol on improving liver function
Scientific Title:Acronym A clinical study for evaluating the effects of maltitol on improving liver function
Region
Japan

Condition
Condition None
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of maltitol intake for 12 weeks on improving liver function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes AST and ALT (0w, 4w, 8w, 12w)
Key secondary outcomes Fatty liver grade determined by abdominal ultrasonography (12w)
Body fat percentage (0w, 4w, 8w, 12w)

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake of the capsules containing low-dose maltitol for 12 weeks
Interventions/Control_2 Intake of the capsules containing high-dose maltitol for 12 weeks
Interventions/Control_3 Intake of the placebo capsules for 12 weeks
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
65 years-old >=
Gender Male and Female
Key inclusion criteria 1) Healthy subjects aged from 20 to 65 years old
2) Subjects whose serum AST or ALT is 31 IU/L or more and 50 IU/L or less
3) Subjects whose BMI is 18.5 kg/m2 or more and less than 30 kg/m2
4) Subjects who have a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent
Key exclusion criteria 1) Subjects receiving treatment for fatty liver
2) Subjects receiving treatment for diabetes or dyslipidemia
3) Subjects with suspicion of cirrhosis of the liver
4) Subjects with suspicion of viral hepatitis
5) Subjects with a heavy alcohol consumption (>=30 g/day for men, >=20 g/day for women)
6) Subjects who have severe liver, cardiovascular, respiratory, endocrine or metabolic diseases
7) Subjects who have the possibility of developing allergic symptoms by the test food
8) Subjects who are during pregnancy or lactation, and intend to be pregnant during the study period.
9) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months (e.g. donated blood) prior to the start of the present study
10)Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
11) Subjects deemed unsuitable by the investigator
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Fukuda
Organization Fukuda Clinic
Division name Director
Zip code
Address Shin-Osaka Brick Building 2F, 1-6-1, Miyahara, Yodogawa-ku, Osaka, Osaka
TEL 06-6398-0203
Email fukuda@drmog.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Sugino
Organization Soiken Inc.
Division name Representative Director
Zip code
Address Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL 06-6871-8888
Homepage URL
Email sugino@soiken.com

Sponsor
Institute Soiken Inc.
Institute
Department

Funding Source
Organization UENO FOOD TECHNO INDUSTRY, 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
Address
Tel
Email

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 医療法人弘正会ふくだ内科クリニック(大阪府)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 30 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 Completed
Date of protocol fixation
2017 Year 02 Month 18 Day
Date of IRB
2017 Year 02 Month 18 Day
Anticipated trial start date
2017 Year 05 Month 27 Day
Last follow-up date
2017 Year 09 Month 03 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 05 Month 26 Day
Last modified on
2019 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031286

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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