UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039462
Receipt number 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 2024/03/02 09:27:20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Waseda University

Institute

Department

Personal name



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

20

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

under analyses of the data.

Date of the first journal publication of results

2023 Year 12 Month 31 Day

Baseline Characteristics


Participant flow


Adverse events

Non

Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2020 Year 02 Month 12 Day

Date of IRB

2020 Year 02 Month 12 Day

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

2024 Year 03 Month 02 Day



Link to view the page

Value
https://center6.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