UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044547
Receipt number R000050894
Scientific Title Effect of arabinoxylan intake on plasma acetate concentration (pilot study)
Date of disclosure of the study information 2021/06/17
Last modified on 2022/06/21 09:12:25

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Basic information

Public title

Effect of arabinoxylan intake on plasma acetate concentration (pilot study)

Acronym

Effect of arabinoxylan intake on plasma acetate concentration (pilot study)

Scientific Title

Effect of arabinoxylan intake on plasma acetate concentration (pilot study)

Scientific Title:Acronym

Effect of arabinoxylan intake on plasma acetate concentration (pilot study)

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of arabinoxylan intake on plasma acetic acid concentration in healthy adults

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Tmax value of acetate after arabinoxylan intake

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

Prevention

Type of intervention

Food

Interventions/Control_1

serial containing arabinoxylan intake (80g, once)

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

1. Subjects having an ability to understand study purpose and detail with voluntary written informed consent

2. Subjects having arabinoxylan assimilating bacteria

Key exclusion criteria

1. Subjects taking antibiotics or any drugs affect on microbiota

2. Subjects with food allergies, especially for wheat and/or milk

3. Pregnant women

4. Subjects participating or willing to participate in other clinical studies

5. Subjects judged as unsuitable for the study participant from other reasons

Target sample size

6


Research contact person

Name of lead principal investigator

1st name Atsushi
Middle name
Last name Gomi

Organization

Yakult Honsha Co., Ltd

Division name

Yakult Central Institute

Zip code

186-8650

Address

5-11 Izumi, Kunitachi-shi Tokyo, Japan

TEL

042-577-8960

Email

atsushi-gomi@yakult.co.jp


Public contact

Name of contact person

1st name Chiaki
Middle name
Last name Kaga

Organization

Yakult Honsha Co., Ltd

Division name

Yakult Central Institute

Zip code

186-8650

Address

5-11 Izumi, Kunitachi-shi Tokyo, Japan

TEL

042-577-8960

Homepage URL


Email

chiaki-kaga@yakult.co.jp


Sponsor or person

Institute

Yakult Honsha Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

Yakult Honsha 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

Chiyoda medical care clinic IRB

Address

3-3-5 Uchikanda, Chiyoda-ku Tokyo, Japan

Tel

03-5297-5548

Email

IRB@cpcc.co.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

2021 Year 06 Month 17 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

2021 Year 05 Month 20 Day

Date of IRB

2021 Year 05 Month 21 Day

Anticipated trial start date

2021 Year 06 Month 21 Day

Last follow-up date

2021 Year 07 Month 09 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2021 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2021 Year 06 Month 15 Day

Last modified on

2022 Year 06 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050894


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name