UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation study of 400m run performance in university athletes after ingestion of test foods
Acronym	Evaluation study of 400m run performance after ingestion of test foods
Scientific Title	Evaluation study of 400m run performance in university athletes after ingestion of test foods
Scientific Title:Acronym	Evaluation study of 400m run performance after ingestion of test foods
Region	Japan

Condition
Condition	Healthy Male University Students
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the effect of a single dose of test food on the performance of 400m run performance
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Performance during 400m race (time, stride width, pitch, breathing rate, heart rate, VAS)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food Other
Interventions/Control_1	Exercise load and placebo blood drawing
Interventions/Control_2	Exercise load and test food (active ingredient 10mg) blood drawing
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	60 years-old >
Gender	Male
Key inclusion criteria	1)Healthy subjects who belonged to a university and trained to run 400 m 2)Subjects who can participate in dietary interventions, intake of test foods, blood samplings, urine samplings, and maintain rest as scheduled 3)Subjects who voluntarily give written informed consent
Key exclusion criteria	1)Subjects whose blood test results are judged to be ineligible for this study by lead principal investigator 2)Subjects with gastrointestinal, cardiovascular, endocrine, or other disorders, or with a history of such disorders, who are judged by lead principal investigator to be ineligible for the study 3)As a rule, subjects who regularly use drugs for the treatment of diseases 4)Subjects who consume health food products that affect the test 5)Subjects who may conduct doping tests 6)Subjects who are judged to be ineligible for this study by lead principal investigator
Target sample size	16

Research contact person
Name of lead principal investigator	1st name Koichi Middle name Last name Okita
Organization	Hokusho university
Division name	Graduate School of Lifelong Sport
Zip code	069-8511
Address	23 Bunkyodai, Ebetsu, Hokkaido
TEL	+81-11-386-8011
Email	okitak@hokusho-u.ac.jp

Public contact
Name of contact person	1st name Yasutaka Middle name Last name Ikeda
Organization	Otsuka Pharmaceutical Co., Ltd.
Division name	Saga Nutraceuticals Research Institute
Zip code	842-0195
Address	5006-5 Yoshinogari-cho, Kanzaki-gun, Saga
TEL	+81-952-52-1522
Homepage URL
Email	Ikeda.Yasutaka@otsuka.jp

Sponsor
Institute	Hokusho university
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical 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	The Ethics Committee of Otsuka Pharmaceutical Co., Ltd.
Address	Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
Tel	+81-3-6717-1499
Email	shimizu_se@otsuka.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	2022 Year 11 Month 23 Day

Related information
URL releasing protocol	under submission
Publication of results	Unpublished

Result
URL related to results and publications	under submission
Number of participants that the trial has enrolled	16
Results	400m run performance was significantly improved after ingestion of test foods
Results date posted	2022 Year 11 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Healthy Volunteers
Participant flow	Subjects were selected based on the key inclusion and exclusion criteria
Adverse events	ND
Outcome measures	Primary Outcomes: 400m run performance
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 01 Day
Date of IRB	2017 Year 07 Month 27 Day
Anticipated trial start date	2017 Year 10 Month 13 Day
Last follow-up date	2017 Year 11 Month 27 Day
Date of closure to data entry	2017 Year 12 Month 20 Day
Date trial data considered complete	2017 Year 12 Month 20 Day
Date analysis concluded	2018 Year 03 Month 27 Day

Other
Other related information

Management information
Registered date	2022 Year 11 Month 22 Day
Last modified on	2022 Year 11 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056473