UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044719
Receipt number R000051056
Scientific Title Effects of food composition on blood fluidity after exercise: in vitro evaluation
Date of disclosure of the study information 2021/07/01
Last modified on 2021/06/30 17:12:19

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Basic information

Public title

Effects of food composition on blood fluidity after exercise: in vitro evaluation

Acronym

Effects of food composition on blood fluidity after exercise: in vitro evaluation

Scientific Title

Effects of food composition on blood fluidity after exercise: in vitro evaluation

Scientific Title:Acronym

Effects of food composition on blood fluidity after exercise: in vitro evaluation

Region

Japan


Condition

Condition

healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate the effects of food compositions on blood fluidity impaired after exercise in vitro.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Whole blood passage time before exercise and after exercise containing food compositions.

Key secondary outcomes

Red blood cell suspension passage time, percentage of obstructed microchannels, number of adherent white blood cells on the microchannel terrace before exercise and after exercise containing food compositions.
Red blood cell counts, white blood cell counts, platelet counts, hematocrit levels, and body weights before and after exercise.


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


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Ergometer exercise (30 minutes, 70% levels of the maximal oxygen consumption)

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


Not applicable

Gender

Male

Key inclusion criteria

1)Subjects who have given written informed consent after a full explanation of the purpose and contents of the study
2)Male
3)Age: 20 years or older

Key exclusion criteria

1)Smokers
2)Patients with internal disorders
3)Subjects who take medicine or dietary supplements
4)Subjects judged inappropriate by the principal investigator

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Hironobu
Middle name
Last name Hamada

Organization

Hiroshima University

Division name

Department of Physical Analysis and Therapeutic Sciences

Zip code

734-8553

Address

1-2-3, Kasumi, Minami-ku, Hiroshima

TEL

082-257-5420

Email

hirohamada@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name Hironobu
Middle name
Last name Hamada

Organization

Hiroshima University

Division name

Department of Physical Analysis and Therapeutic Sciences

Zip code

734-8553

Address

1-2-3, Kasumi, Minami-ku, Hiroshima

TEL

082-257-5420

Homepage URL


Email

hirohamada@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima University

Institute

Department

Personal name



Funding Source

Organization

Hiroshima University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical Committee for Epidemiology of Hiroshima University

Address

1-2-3, Kasumi, Minami-ku, Hiroshima

Tel

082-257-5907

Email

iryo-seisaku@office.hiroshima-u.ac.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

2021 Year 07 Month 01 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

Open public recruiting

Date of protocol fixation

2016 Year 06 Month 13 Day

Date of IRB

2016 Year 09 Month 02 Day

Anticipated trial start date

2019 Year 02 Month 21 Day

Last follow-up date

2024 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

2021 Year 06 Month 30 Day

Last modified on

2021 Year 06 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051056


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name