UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063079 |
|---|---|
| Receipt number | R000072212 |
| Scientific Title | Randomized, double-blind, crossover trial on the effects of dextrin intake on the improvement of exercise performance |
| Date of disclosure of the study information | 2026/09/28 |
| Last modified on | 2026/09/28 17:13:14 |
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Basic information
Public title
Randomized, double-blind, crossover trial on the effects of dextrin intake on the improvement of exercise performance
Acronym
Randomized, double-blind, crossover trial on the effects of dextrin intake on the improvement of exercise performance
Scientific Title
Randomized, double-blind, crossover trial on the effects of dextrin intake on the improvement of exercise performance
Scientific Title:Acronym
Randomized, double-blind, crossover trial on the effects of dextrin intake on the improvement of exercise performance
Region
| Japan |
Condition
Condition
Healthy male Ekiden team member
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of ingesting highly branched cyclic dextrin which is digested and absorbed relatively slowly on performance in a long-distance running time trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time trial score
Key secondary outcomes
Heart rate, gastrointestinal strain scores before and after the experiment, and fatigue scores after the experiment.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: 1 day
Test product: Beverage containing highly branched cyclic dextrin
Interventions/Control_2
Duration: 1 day
Test product: glucose-containing drink
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy male Ekiden team members aged 18 to under 25
Key exclusion criteria
1 Individuals with diabetes or abnormal glucose metabolism
2 Individuals using medications that affect blood glucose levels
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Sato |
Organization
Shibaura Institute of Technology
Division name
College of Systems Engineering and Science
Zip code
337-8570
Address
307 Fukasaku, Minuma-ku, Saitama-shi, Saitama
TEL
048-720-6016
hiroki@shibaura-it.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Hosogi |
Organization
Glico Nutrition Co., Ltd.
Division name
R&D Center
Zip code
555-8502
Address
4-6-5, Utajima, Nishiyodogawa-Ku, Osaka, Japan
TEL
050-1744-4293
Homepage URL
yumi.hosogi@glico.com
Sponsor or person
Institute
Glico Nutrition Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Glico Nutrition Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shibaura Institute of Technology, College of Systems Engineering and Science, Department of Life Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shibaura Institute of Technology Research Ethics Committee for Biotechnology
Address
3-7-5 Toyosu, Koto-ku, Tokyo
Tel
03-5859-9821
kato.minami@ow.shibaura-it.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
芝浦工業大学（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | 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
14
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 09 | Month | 28 | Day |
Last modified on
| 2026 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072212
