UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063050 |
|---|---|
| Receipt number | R000072136 |
| Scientific Title | Effects of Paramylon (beta-glucan) Intake on Recovery and Conditioning in Female Athletes: Open-label Single-arm Before-After Study |
| Date of disclosure of the study information | 2026/09/25 |
| Last modified on | 2026/09/25 13:21:30 |
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Basic information
Public title
Effects of Paramylon-containing Yogurt on Physical Condition in Female Collegiate Athletes
Acronym
Effects of Paramylon-Containing Yogurt on Fatigue and Physical Condition in Female Collegiate Athletes
Scientific Title
Effects of Paramylon (beta-glucan) Intake on Recovery and Conditioning in Female Athletes: Open-label Single-arm Before-After Study
Scientific Title:Acronym
Effects of Paramylon (beta-glucan) Intake on Recovery and Conditioning in Female Athletes: Open-label Single-arm Before-After Study
Region
| Japan |
Condition
Condition
Female collegiate soccer players aged 18 to 22 years
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of Four-Week Consumption of Paramylon-Containing Yogurt on Sleep, Fatigue, Menstrual Symptoms, Bowel Function, Autonomic Nervous System Activity, and Immune Markers
Basic objectives2
Others
Basic objectives -Others
Effects in Pittsburgh Sleep Quality Index (PSQI), Chalder Fatigue Scale, and Visual Analog Scale (VAS) Fatigue Scores
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Effects of Four-Week Consumption of Paramylon-Containing Yogurt on Sleep, Fatigue, Menstrual Symptoms, Bowel Function, Autonomic Nervous System Activity, and Immune Markers
Key secondary outcomes
Changes in MDQ Scores, Bowel Function, Autonomic Nervous System Indices, Salivary Immunoglobulin A (IgA) and Oxytocin Levels, Body Composition, and Gut Microbiota-Related Indicators
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily consumption of 90 g of yogurt containing 500 mg of Euglena gracilis EOD-1 powder (providing at least 350 mg of paramylon) for four weeks.
Interventions/Control_2
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
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
Female soccer players belonging to the Tezukayama Gakuin University Women's Soccer Team
Key exclusion criteria
Participants undergoing treatment for chronic diseases, those with food allergies, or those with a history of serious medical conditions.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Suzuki |
Organization
Tezukayama Gakuin University
Division name
Faculty of Food and Nutrition Science
Zip code
5900113
Address
4-2-2, Harumidai, Minami-ku, Sakai, Osaka 5900113, Japan
TEL
81-72-296-1331
t-suzuki@tezuka-gu.ac.jp
Public contact
Name of contact person
| 1st name | Toshio |
| Middle name | |
| Last name | Suzuki |
Organization
Tezukayama Gakuin University
Division name
Faculty of Food and Nutrition Science
Zip code
5900113
Address
4-2-2, Harumidai, Minami-ku, Sakai, Osaka 5900113, Japan
TEL
81-72-296-1331
Homepage URL
t-suzuki@tezuka-gu.ac.jp
Sponsor or person
Institute
Toshio Suzuki
Tezukayama Gakuin University
Faculty of Food and Nutrition Science
Institute
Department
Personal name
Funding Source
Organization
Ikaruga Milk Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tezukayama Gakuin University Life Science Ethics Committee
Address
4-2-2, Harumidai, Minami-ku, Sakai, Osaka 5900113, Japan
Tel
81-72-296-1331
t-suzuki@tezuka-gu.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 25 | 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 | 09 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 20 | 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 | 25 | Day |
Last modified on
| 2026 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072136
