UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037405
Receipt number 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 13:35:57

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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 or person

Institute

Obihiro University of Agriculture and Veterinary Medicine

Institute

Department

Personal name



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

Value
https://center6.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