UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060625 |
|---|---|
| Receipt number | R000069279 |
| Scientific Title | Effect of test foods on ease of intake and gastrointestinal symptoms during exercise |
| Date of disclosure of the study information | 2026/02/09 |
| Last modified on | 2026/02/09 10:07:20 |
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Basic information
Public title
Effect of test foods on ease of intake and gastrointestinal symptoms during exercise
Acronym
Effect of test foods on ease of intake and gastrointestinal symptoms during exercise
Scientific Title
Effect of test foods on ease of intake and gastrointestinal symptoms during exercise
Scientific Title:Acronym
Effect of test foods on ease of intake and gastrointestinal symptoms during exercise
Region
| Japan |
Condition
Condition
Healthy male
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the ease of intake and effects on gastrointestinal symptoms of nutritional supplements used during exercise
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gastrointestinal parameters (GI symptoms, Blood I-FABP, IL-6, Cortisol)
Ease of intake
Key secondary outcomes
Perceived exertion
Adverse events (presence and severity)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food 1
Interventions/Control_2
Test food 2
Interventions/Control_3
Test food 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
1. Male university students belonging to a track and field club (or equivalent) who specialize in long-distance running of 5000m or longer.
2. Individuals aged 18 to less than 26 years at the time of obtaining informed consent.
3. Individuals whose personal best record in an official 5000m race within the past year is between 14 minutes 00 seconds and 15 minutes 30 seconds.
4. Individuals who agree not to change their dietary habits during the study period.
5. Healthy individuals with no chronic physical diseases.
6. Individuals who have received a full explanation regarding the purpose and content of the study, possess the capacity to consent, fully understand the study, voluntarily desire to participate, and are able to provide written consent.
7. Individuals able to undergo measurements on the designated dates.
Key exclusion criteria
1. Individuals with symptoms of any chronic disease.
2. Individuals with a history or current history of severe hepatic, renal, cardiac, pulmonary, or hematological disorders.
3. Individuals with comorbidities or a history of gastrointestinal diseases (however, a history judged by the principal investigator not to affect study participation is acceptable).
4. Individuals with food allergies (including a history of such allergies).
5. Individuals with alcohol dependence or other psychiatric disorders.
6. Individuals with severe anemia.
7. Individuals with a smoking habit.
8. Individuals likely to change their lifestyle habits during the study period (e.g., night shifts, long-term travel).
9. Individuals planning to start taking new Foods with Health Claims or supplements during the study period.
10. Individuals who have had a period of training interruption due to injury lasting 1 week or more within the past 2 months.
11. Individuals who have received treatment requiring hospitalization within the past 6 months.
12. Individuals currently participating in other human studies, or within 3 months after participating in other human studies.
13. Others judged by the principal investigator to be inappropriate for this study.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Iemoto |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL
045-571-6140
n-iemoto-jb@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Seto |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL
045-571-6140
Homepage URL
y-seto-bd@morinaga.co.jp
Sponsor or person
Institute
Morinaga & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga & 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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2026 | Year | 02 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2026 | 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 | 02 | Month | 09 | Day |
Last modified on
| 2026 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069279
