UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027503 |
|---|---|
| Receipt number | 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 13:38:16 |
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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
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
sugino@soiken.com
Sponsor or person
Institute
Soiken Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031286
