UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045626 |
|---|---|
| Receipt number | R000050828 |
| Scientific Title | The effect of nutritional intake method on digestion and absorption after exercise |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2022/03/18 12:49:08 |
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Basic information
Public title
The effect of nutritional intake method on digestion and absorption after exercise
Acronym
Research on nutrition and digestion after exercise
Scientific Title
The effect of nutritional intake method on digestion and absorption after exercise
Scientific Title:Acronym
Research on nutrition and digestion after exercise
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the effects of post-exercise nutritional temperature on digestion, absorption, and metabolism in healthy males between the ages of 20 and 40.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Glucose concentration
Key secondary outcomes
Height, weight, heart rate during exercise, subjective exercise intensity, subjective level of fatigue, stomach discomfort, hunger, expiration
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Consume a 60-degree carbohydrate-protein drink after exercise
Interventions/Control_2
Consume a 2-degree carbohydrate-protein drink after exercise
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
Between 20 and 40 years old, healthy male
Key exclusion criteria
Those who cannot endure 30 minutes of exercise, women, and those with smoking habits.
Between 20 and 40 years old, healthy male
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Institute of Technology
Division name
Institute for Liberal Arts
Zip code
152-8550
Address
2-12-1, Ookayama, Meguro-ku, Tokyo
TEL
03-5734-2904
fujihira.k.ac@m.titech.ac.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Fujihira |
Organization
Tokyo Institute of Technology
Division name
Institute for Liberal Arts
Zip code
152-8550
Address
2-12-1, Ookayama, Meguro-ku, Tokyo
TEL
03-5734-2467
Homepage URL
fujihira.k.ac@m.titech.ac.jp
Sponsor or person
Institute
Tokyo Institute of Technology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Waseda University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Institute of Technology
Address
2-12-1, Ookayama, Meguro-ku, Tokyo
Tel
03-5734-3808
hitorinri@jim.titech.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
東京工業大学、その他関連機関
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | 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
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 10 | 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 | 10 | Month | 01 | Day |
Last modified on
| 2022 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050828
