UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033331
Receipt number R000037994
Scientific Title Study on intestinal environment and nutritional status in university students.
Date of disclosure of the study information 2018/07/17
Last modified on 2021/03/01 13:24:31

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Basic information

Public title

Study on intestinal environment and nutritional status in university students.

Acronym

Study on intestinal environment in university students.

Scientific Title

Study on intestinal environment and nutritional status in university students.

Scientific Title:Acronym

Study on intestinal environment in university students.

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the relationships between intestinal environment and nutritional status in healthy subjects.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Association between intestinal environment(16S rRNA gene-based metagenome analysis of gut microbiome and intestinal metabolites) and nutritional status (anthropometric data, body composition, muscle strength and diet record)

Key secondary outcomes



Base

Study type

Observational


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Subjects who have given written informed consent
2)Subjects who have participated in the study "Effects of long-term ingestion of protein-rich milk on muscle strength in university students"(UMIN000027032)

Key exclusion criteria

Subjects who are judged as ineligible by the lead study conductor

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Okaya Eiji

Organization

Meiji Co., Ltd.

Division name

Food science & Technology Research Laboratories, R&D Division

Zip code


Address

1-29-1 Nanakuni, Hachiouji, Tokyo, JAPAN

TEL

042-632-5849

Email

eiji.okaya@meiji.com


Public contact

Name of contact person

1st name
Middle name
Last name Yamaguchi Makoto

Organization

Meiji Co., Ltd.

Division name

Food science & Technology Research Laboratories, R&D Division

Zip code


Address

1-29-1 Nanakuni, Hachiouji, Tokyo, JAPAN

TEL

042-632-5849

Homepage URL


Email

makoto.yamaguchi@meiji.com


Sponsor or person

Institute

Meiji Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

株式会社 明治 研究本部/ R&D Division, Meiji Co., Ltd.


Other administrative information

Date of disclosure of the study information

2018 Year 07 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

2018 Year 07 Month 06 Day

Date of IRB

2018 Year 07 Month 06 Day

Anticipated trial start date

2018 Year 07 Month 17 Day

Last follow-up date

2018 Year 10 Month 16 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2018 Year 07 Month 09 Day

Last modified on

2021 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037994


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name