UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035391 |
|---|---|
| Receipt number | R000040325 |
| Scientific Title | Effects of a single ingestion of trehalose on exercise performance |
| Date of disclosure of the study information | 2018/12/28 |
| Last modified on | 2018/12/28 15:04:38 |
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Basic information
Public title
Effects of a single ingestion of trehalose on exercise performance
Acronym
Effects of a single ingestion of trehalose on exercise performance
Scientific Title
Effects of a single ingestion of trehalose on exercise performance
Scientific Title:Acronym
Effects of a single ingestion of trehalose on exercise performance
Region
| Japan |
Condition
Condition
Healthy college students
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate the effects of a single ingestion of trehalose on 1) exercise performance (the Wingate test) during the later stages of prolonged exercise and 2) energy metabolism during low-intensity (40% VO2peak) constant-load exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
We compared performance in the Wingate test after a single ingestion of glucose and trehalose solutions in 25 healthy male college students.
Key secondary outcomes
We compared the effects of a single ingestion of glucose and trehalose solutions on energy metabolism during 1-hour exercise at 40% VO2peak in 34 healthy college students (24 males and 10 females).
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Glucose - Trehalose
The subjects performed the examination of the same protocol a total of 3 times by randomly changing the type of the test drink to be ingested. The test drink ingested at the end of the first set was water (trial W), or an 8% glucose (trial G) or trehalose (trial T) solution. The subjects ingested 500 mL of the test drink within 5 minutes after the end of the first set.
Interventions/Control_2
Trehalose - Glucose
The subjects performed the examination of the same protocol a total of 3 times by randomly changing the type of the test drink to be ingested. The test drink ingested at the end of the first set was water (trial W), or an 8% glucose (trial G) or trehalose (trial T) solution. The subjects ingested 500 mL of the test drink within 5 minutes after the end of the first set.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy college students
Key exclusion criteria
Not healthy college students
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Wadazumi |
Organization
Kansai University
Division name
Faculty of Health and Well-being
Zip code
Address
1-11-1 Kaorigaoka-cho, Sakai-ku, Sakai-shi, Osaka
TEL
072-229-5022
wadazumi@kansai-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Wadazumi |
Organization
Kansai University
Division name
Faculty of Health and Well-being
Zip code
Address
1-11-1 Kaorigaoka-cho, Sakai-ku, Sakai-shi, Osaka
TEL
072-229-5022
Homepage URL
wadazumi@kansai-u.ac.jp
Sponsor or person
Institute
Kansai University,
Faculty of Health and Well-being
Institute
Department
Personal name
Funding Source
Organization
Kansai University,
Faculty of Health and Well-being
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hayashibara Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 12 | Month | 28 | 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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 28 | Day |
Last modified on
| 2018 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040325
