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 | 2026/03/11 17:09:35 |
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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
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
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
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
https://journals.sagepub.com/doi/full/10.3233/CH-211201
Publication of results
Published
Result
URL related to results and publications
https://journals.sagepub.com/doi/full/10.3233/CH-211201
Number of participants that the trial has enrolled
10
Results
Exercise increased the hematocrit levels. The blood passage times, percentage of obstructed microchannels, and the number of adherent WBCs on the microchannel terrace increased after exercise; however, they decreased in a dose-dependent manner after the addition of L-arginine. L-NMMA inhibited the L-arginine-induced decrease in blood passage time.
Results date posted
| 2026 | Year | 03 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Ten healthy male
Participant flow
Smokers, patients with internal disorders, and those who use medicine or dietary supplements were excluded from the study.
Adverse events
None
Outcome measures
Using microchannel method, we measured the blood passage time, percentage of obstructed microchannels, and the number of adherent white blood cells on the microchannel terrace.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2026 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051056
