UMIN-CTR Clinical Trial

Basic information
Public title	The effect of the algal food intake on athlete performance Open study
Acronym	The effect of the algal food intake on athlete performance
Scientific Title	The effect of the algal food intake on athlete performance Open study
Scientific Title:Acronym	The effect of the algal food intake on athlete performance
Region	Japan

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

Objectives
Narrative objectives1	To consider whether ingesting algae foods can contribute to athlete performance
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	cyclic ergometer
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	To intake algal food
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	60 years-old >
Gender	Male
Key inclusion criteria	(1)The age at the time of obtaining a consent is 20 years or older. (2)Male (3)Those from whom a written consent can be obtained on a voluntary basis
Key exclusion criteria	The person who is unsuitable for the entry judged by a officer
Target sample size	16

Research contact person
Name of lead principal investigator	1st name Kazuyoshi Middle name Last name Ootani
Organization	KOBELCO ECO-SOULUTIONS CO.,LTD
Division name	Algae Business Promotion Dept.
Zip code	651-0072
Address	4-78, 1-chome, Wakinohama-cho, Chuo-ku, Kobe 651-0072, Japan
TEL	078-232-8223
Email	k.otani@kobelco-eco.co.jp

Public contact
Name of contact person	1st name Kazuyoshi Middle name Last name Ootani
Organization	KOBELCO ECO-SOULUTIONS CO.,LTD
Division name	Algae Business Promotion Dept.
Zip code	651-0072
Address	4-78, 1-chome, Wakinohama-cho, Chuo-ku, Kobe 651-0072, Japan
TEL	078-232-8223
Homepage URL
Email	k.otani@kobelco-eco.co.jp

Sponsor
Institute	KOBELCO ECO-SOULUTIONS CO.,LTD
Institute
Department

Funding Source
Organization	KOBELCO ECO-SOULUTIONS 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	Ginza Hospital
Address	4-12-15, Ginza, Chuou-ku, Tokyo, Japan
Tel	03-3542-2660
Email	j-noguchi@ginzahospital.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	2019 Year 05 Month 07 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 04 Month 05 Day
Date of IRB	2018 Year 04 Month 12 Day
Anticipated trial start date	2018 Year 05 Month 21 Day
Last follow-up date	2018 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 05 Month 07 Day
Last modified on	2020 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036916