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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039462
Receipt No. R000044994
Scientific Title Effects of long-term ingestion of immune protein on body's function in athletes
Date of disclosure of the study information 2020/02/12
Last modified on 2020/02/12

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Basic information
Public title Effects of long-term ingestion of immune protein on body's function in athletes
Acronym Effects of long-term ingestion of immune protein on body's function in athletes
Scientific Title Effects of long-term ingestion of immune protein on body's function in athletes
Scientific Title:Acronym Effects of long-term ingestion of immune protein on body's function in athletes
Region
Japan

Condition
Condition athletes
Classification by specialty
Medicine in general Gastroenterology Endocrinology and Metabolism
Nephrology Clinical immunology Orthopedics
Laboratory medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study examine the effects of long-term ingestion on immune protein on body's function in athletes.
Basic objectives2 Others
Basic objectives -Others The subjects ingest immune protein twice a day (40g) for two months. Blood, urine and fecal samples will be collected before and after the training in prior to, in the middle and at the endo of the administration period, and anti-inflammatory effects of immune protein will be evaluated.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes inflammatory response (2 months after the administration)
Key secondary outcomes bacterial flora

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 The subjects ingest immune protein twice a day (40g) for two months.
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
30 years-old >=
Gender Male and Female
Key inclusion criteria Athletes between 18 and 30 years old.
Key exclusion criteria Persons who have food allergy to milk and soybean, cannot stop alcohol drinking before the experimental days, and take anti-allergy and anti-inflammatory drags.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name katsuhiko
Middle name
Last name Suzuki
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code 359-1192
Address 2-579-15 Mikajima, Tokorozawa, Saitama
TEL 04-2947-6898
Email katsu.suzu@waseda.jp

Public contact
Name of contact person
1st name katsuhiko
Middle name
Last name Suzuki
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code 359-1192
Address 2-579-15 Mikajima, Tokorozawa, Saitama
TEL 04-2947-6898
Homepage URL
Email katsu.suzu@waseda.jp

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization Ortho Corporation, Shibuya, 150-0002, Japan
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee of Waseda University
Address 1-1-4 Nishi-waseda, Shinjyuku, Tokyo
Tel 03-5272-1639
Email rinri@list.waseda.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 早稲田大学

Other administrative information
Date of disclosure of the study information
2020 Year 02 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
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 Preinitiation
Date of protocol fixation
2020 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date
2020 Year 02 Month 12 Day
Last follow-up date
2022 Year 03 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
2020 Year 02 Month 12 Day
Last modified on
2020 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044994

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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