UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042752 |
|---|---|
| Receipt number | R000048795 |
| Scientific Title | Single ingestion of trehalose enhances a prolonged exercise performance by effective use of glucose and lipid in healthy men |
| Date of disclosure of the study information | 2020/12/15 |
| Last modified on | 2021/12/06 19:57:44 |
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Basic information
Public title
Effect of trehalose ingestion during prolonged exercise on subsequent maximal exercise performance
Acronym
Effect of trehalose ingestion during prolonged exercise on subsequent maximal exercise performance
Scientific Title
Single ingestion of trehalose enhances a prolonged exercise performance by effective use of glucose and lipid in healthy men
Scientific Title:Acronym
Single ingestion of trehalose enhances a prolonged exercise performance by effective use of glucose and lipid in healthy men
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigate a mechanism of single ingestion of trehalose over the prolonged exercise performance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood glucose
Key secondary outcomes
insulin, adrenaline
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Each participant single ingested 500ml of one of the three solutions during exercise.
water (control)
8% glucose
8% trehalose
Interventions/Control_2
After fasting for 12 hr, using a bicycle ergometer, they first exercised with a constant load for 60 min (intensity: 40% VO2 peak). They then performed a constant load exercise for 30 min (intensity: 40% VO2 peak) between four sets of the 30-s Wingate test with a 4-min recovery period between each set.
Interventions/Control_3
Each participant ingested different solutions and performed the same exercise protocol three times at intervals of one week or more.
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
| 23 | years-old | >= |
Gender
Male
Key inclusion criteria
healthy male college students
Key exclusion criteria
students not in good health
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Naomi |
| Middle name | |
| Last name | HAMADA |
Organization
Higashiosaka Junior College
Division name
Department of Applied Food Science
Zip code
577-8567
Address
3-1-1, Nishidutsumigakuen-cho, Higashiosaka, Osaka 577-8567 Japan
TEL
06-6782-2824
hamada-n@higashiosaka.ac.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | HAMADA |
Organization
Kansai University
Division name
Department of Health and Well-being Faculty of Health and Well-being
Zip code
590-8815
Address
1-11-1 Kaorigaoka-cho, Sakai-ku, Sakai-shi, Osaka 590-8515, JAPAN
TEL
072-229-5022
Homepage URL
hamada-n@higashiosaka.ac.jp
Sponsor or person
Institute
Kansai University
Institute
Department
Personal name
Funding Source
Organization
HAYASHIBARA CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai University
Address
1-11-1 Kaorigaoka-cho, Sakai-ku, Sakai-shi, Osaka 590-8515, JAPAN
Tel
072-229-5022
hamada-n@higashiosaka.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
関西大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 15 | 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
12
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
| 2018 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2020 | 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 | 12 | Month | 14 | Day |
Last modified on
| 2021 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048795
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
