UMIN-CTR Clinical Trial

Basic information
Public title	The effect of the algae food intake on athletes immunity Open study
Acronym	The effect of the algae food intake on athletes immunity
Scientific Title	The effect of the algae food intake on athletes immunity Open study
Scientific Title:Acronym	The effect of the algae food intake on athletes immunity
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of the algal food intake to athlete immunity
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	secretory immunoglobulin A
Key secondary outcomes	Body composition, Subjective evaluation (Feeling of Fatigue, Feeling)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	To intake algal food
Interventions/Control_2	Not to intake algal food
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	40 years-old >
Gender	Male
Key inclusion criteria	(1)Healthy man who are 20 or more to less than 40 years old (2)Healthy people who are not currently treating any visceral disease (3)Those from whom a written consent can be obtained on a voluntary basis
Key exclusion criteria	(1)Individuals using medical products (2)Individuals who are prone to allergies for foods (3)Individiuals who has a history of serious disease / current illness (4)Individiuals who has a history of alcohol and drug addiction (5)Individiuals who is unsuitable for the entry judged by a officer
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Madoka Middle name Last name Takahashi
Organization	KOBELCO ECO-SOULUTIONS CO.,LTD
Division name	Technical Develop Center
Zip code	651-2241
Address	1-1-4, Murotani, Nishi-ku, Kobe 651-2241
TEL	078-992-6957
Email	md.takahashi@kobelco-eco.co.jp

Public contact
Name of contact person	1st name Madoka Middle name Last name Takahashi
Organization	KOBELCO ECO-SOULUTIONS CO.,LTD
Division name	Technical Develop Center
Zip code	651-2241
Address	1-1-4, Murotani, Nishi-ku, Kobe 651-2241
TEL	078-992-6957
Homepage URL
Email	md.takahashi@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	The ethical committee of the Hokubukai Group Utukushigaoko Hospital
Address	61-1, Shinei, Kiyota-ku, Sapporo, 004-0839, Japan
Tel	011-882-0111
Email	wakimoto@ughp-cpc.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 06 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 05 Month 28 Day
Date of IRB	2019 Year 05 Month 29 Day
Anticipated trial start date	2019 Year 06 Month 13 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 06 Month 12 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/icdr_e/ctr_view.cgi?recptno=R000042187