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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037405
Receipt No. R000042637
Scientific Title Effects of betaine (trimethyl glycine) from sugar beet on hepatic function
Date of disclosure of the study information 2019/07/22
Last modified on 2019/07/17

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Basic information
Public title Effects of betaine (trimethyl glycine) from sugar beet on hepatic function
Acronym Effects of betaine from sugar beet on hepatic function
Scientific Title Effects of betaine (trimethyl glycine) from sugar beet on hepatic function
Scientific Title:Acronym Effects of betaine from sugar beet on hepatic function
Region
Japan

Condition
Condition hepatic dysfunction
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Amelioration of hepatic function
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Variation of parameters related hepatic function
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake of 2g of betaine powder, once a day, 8 weeks
Interventions/Control_2
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 Serum alanine aminotransferase level (ALT) is more than 31IU/L
Key exclusion criteria Not applicable
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Michihiro
Middle name
Last name Fukushima
Organization Obihiro University of Agriculture and Veterinary Medicine
Division name Department of Life and Food Sciences
Zip code 0808555
Address West 2-11, Inada, Obihiro, Hokkaido
TEL 0155-49-5557
Email fukushim@obihiro.ac.jp

Public contact
Name of contact person
1st name Nana
Middle name
Last name Mikami
Organization Obihiro University of Agriculture and Veterinary Medicine
Division name Department of Life and Food Sciences
Zip code 0808555
Address West 2-11, Inada, Obihiro, Hokkaido
TEL 0155-49-5570
Homepage URL
Email nanam@obihiro.ac.jp

Sponsor
Institute Obihiro University of Agriculture and Veterinary Medicine
Institute
Department

Funding Source
Organization Not applicable
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Obihiro University of Agriculture and Veterinary Medicine
Address West 2-11, Inada, Obihiro, Hokkaido
Tel 0155-49-5345
Email shien@obihiro.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
2019 Year 07 Month 22 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 5
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason Now preparing for submission
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
2013 Year 02 Month 12 Day
Date of IRB
2013 Year 02 Month 12 Day
Anticipated trial start date
2013 Year 06 Month 25 Day
Last follow-up date
2013 Year 08 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 07 Month 18 Day
Last modified on
2019 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042637

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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