UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041534
Receipt number R000047416
Scientific Title Additional analysis of the intestinal environment on the previous study: The evaluation test of glucose tolerance change and intestinal environmental change by intake of barley
Date of disclosure of the study information 2020/08/24
Last modified on 2023/06/30 10:58:07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Additional analysis of the intestinal environment on the previous study: The evaluation test of glucose tolerance change and intestinal environmental change by intake of barley

Acronym

Additional analysis of the intestinal environment on the previous study: The evaluation test of glucose tolerance change and intestinal environmental change by intake of barley

Scientific Title

Additional analysis of the intestinal environment on the previous study: The evaluation test of glucose tolerance change and intestinal environmental change by intake of barley

Scientific Title:Acronym

Additional analysis of the intestinal environment on the previous study: The evaluation test of glucose tolerance change and intestinal environmental change by intake of barley

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluate the fecal IgA level on the previous study: The evaluation test of glucose tolerance change and intestinal environmental change by intake of barley (UMIN000023675).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Total IgA amount in fecal samples

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

50 years-old <=

Age-upper limit

69 years-old >=

Gender

Male and Female

Key inclusion criteria

Subjects who included the previous study: The evaluation test of glucose tolerance change and intestinal environmental change by intake of barley (UMIN000023675)

Key exclusion criteria

Subjects who excluded the data analysis of the previous study: The evaluation test of glucose tolerance change and intestinal environmental change by intake of barley (UMIN000023675)

Target sample size

19


Research contact person

Name of lead principal investigator

1st name Shinji
Middle name
Last name Fukuda

Organization

Metabologenomics, Inc.

Division name

Headquarters

Zip code

997-0052

Address

246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan

TEL

+81-235-64-0330

Email

research@metagen.co.jp


Public contact

Name of contact person

1st name Makoto
Middle name
Last name Ichinohe

Organization

CPCC Company Limited

Division name

Clinical Research Planning Department

Zip code

101-0047

Address

4F Sanwauchikanda Building, 3-3-5 Uchikanda, Chiyoda-ku, Tokyo, Japan

TEL

+81-3-5927-3112

Homepage URL


Email

cpcc-contact@cpcc.co.jp


Sponsor or person

Institute

Metabologenomics, Inc.

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Hakubaku Co.,Ltd.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Sanwauchikanda Building, 3-3-5 Uchikanda, Chiyoda-ku, Tokyo, Japan

Tel

+81-3-5297-5548

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

2020 Year 08 Month 24 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

2020 Year 08 Month 14 Day

Date of IRB

2020 Year 08 Month 21 Day

Anticipated trial start date

2020 Year 08 Month 24 Day

Last follow-up date

2021 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Evaluate the fecal IgA level on the previous study: The evaluation test of glucose tolerance change and intestinal environmental change by intake of barley (UMIN000023675).
There is no additional intervention and sample collection.


Management information

Registered date

2020 Year 08 Month 24 Day

Last modified on

2023 Year 06 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047416


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name