UMIN-CTR Clinical Trial

Basic information
Public title	Relationships between endurance performance and intestinal flora in university students
Acronym	Relationships between endurance performance and intestinal flora in university students
Scientific Title	Relationships between endurance performance and intestinal flora in university students
Scientific Title:Acronym	Relationships between endurance performance and intestinal flora in university students
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To conduct a follow-up survey on changes in endurance performance and intestinal flora in young athletes (university students) for one year so as to discover the relationships between endurance performance and intestinal flora
Basic objectives2	Others
Basic objectives -Others	Observational study
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlations between middle distance running performance and intestinal flora
Key secondary outcomes	Correlations between intestinal flora and the following outcomes: body composition, blood parameter, physical condition and nutritional intake

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	18 years-old <=
Age-upper limit	22 years-old >=
Gender	Male
Key inclusion criteria	Male university students belong to long distance runner team in Nihon University
Key exclusion criteria	A person who is deemed inappropriate as a subject by the principal investigator
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Chiaki Middle name Last name Sanbongi
Organization	Meiji Co., Ltd.
Division name	R & D Division
Zip code	192-0919
Address	1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
TEL	+81-42-632-5846
Email	chiaki.sanbongi@meiji.com

Public contact
Name of contact person	1st name Kyosuke Middle name Last name Nakayama
Organization	Meiji Co., Ltd.
Division name	R & D Division
Zip code	192-0919
Address	1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
TEL	+81-42-632-5846
Homepage URL
Email	kyousuke.nakayama@meiji.com

Sponsor
Institute	Meiji Co., Ltd.
Institute
Department

Funding Source
Organization	Self-financing
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	Meiji Institutional Review Board
Address	1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
Tel	+81-42-632-5900
Email	MEIJI.IRB@meiji.com

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 10 Month 12 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	24
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	2019 Year 08 Month 07 Day
Date of IRB	2019 Year 08 Month 07 Day
Anticipated trial start date	2019 Year 10 Month 03 Day
Last follow-up date	2020 Year 11 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Once every three months, data on middle distance running performance, body composition, blood parameter, physical condition, nutritional intake and intestinal flora will be obtained.

Management information
Registered date	2020 Year 10 Month 12 Day
Last modified on	2022 Year 09 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048033