UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060386 |
|---|---|
| Receipt number | R000069082 |
| Scientific Title | Effects of Medium-Chain Triglyceride (MCT) Intake on Gut Microbiota, Bowel Habits, Sleep, and Body Composition in Female High School Softball Players |
| Date of disclosure of the study information | 2026/01/19 |
| Last modified on | 2026/01/17 00:30:57 |
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Basic information
Public title
Effects of Medium-Chain Triglyceride (MCT) Intake on Gut Microbiota, Bowel Habits, Sleep, and Body Composition in Female High School Softball Players
Acronym
Effects of Medium-Chain Triglyceride (MCT) Intake on Gut Microbiota, Bowel Habits, Sleep, and Body Composition in Female High School Softball Players
Scientific Title
Effects of Medium-Chain Triglyceride (MCT) Intake on Gut Microbiota, Bowel Habits, Sleep, and Body Composition in Female High School Softball Players
Scientific Title:Acronym
Effects of Medium-Chain Triglyceride (MCT) Intake on Gut Microbiota, Bowel Habits, Sleep, and Body Composition in Female High School Softball Players
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to exploratorily investigate the effects of two months of medium-chain triglyceride (MCT) intake on gut microbiota, bowel habits, sleep, body composition, and physical condition in nationally competitive female high school softball players.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in gut microbiota composition
Bowel habits / bowel function status
Sleep quality
Body composition
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants in the intervention group will consume MCT orally at a dose of 2.5 g per serving, three times per day (total 7.5 g/day), for two months while continuing their usual diet and training routines.
Interventions/Control_2
Participants in the control group will not consume MCT and will continue their usual diet and training routines (no-treatment / non-intervention control).
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
| 15 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Female
Key inclusion criteria
Nationally competitive female high school softball players
Females aged 15-17 years
Not restricted from regular training or competition due to injury or illness during the study period
Owns a smartphone and is able to use it for study-related procedures
Able to provide assent from the participant and informed consent from a parent or legal guardian
Key exclusion criteria
Unable to obtain assent from the participant or informed consent from a parent or legal guardian, or withdrawal of consent during the study
Difficulty in continuing MCT jelly intake or regular training due to injury or illness during the study period
Presence of gastrointestinal, metabolic, or sleep-related disorders that may affect the study outcomes
Currently receiving medical treatment that requires dietary or nutritional restrictions
Occurrence of adverse events such as diarrhea or gastrointestinal discomfort related to MCT jelly intake, making continuation difficult
Missing key outcome data that make statistical analysis infeasible, as determined by the principal investigator
Significant non-compliance with the study protocol
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Michiyo |
| Middle name | |
| Last name | Kimura |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of health and Welfare
Zip code
370-0033
Address
37-1, Nakaorui, Takasaki city, Gunma, Japan
TEL
027-352-1290
kimura@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Michiyo |
| Middle name | |
| Last name | Kimura |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Health and Welfwre
Zip code
370-0033
Address
37-1, Nakaorui, Takasaki city, Gunma, Japan
TEL
0273521290
Homepage URL
kimura@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Takasaki University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takasaki University of Health and Welfare
Address
37-1, Nakaorui, Takasaki city, Gunma, Japan
Tel
0273521290
mune@takasaki-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2025-8
Org. issuing International ID_1
Graduate School of Arts and Sciences, The University of Tokyo
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 | 01 | Month | 19 | 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
16
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
| 2025 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 13 | 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 | 01 | Month | 17 | Day |
Last modified on
| 2026 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069082
