UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062199 |
|---|---|
| Receipt number | R000071179 |
| Scientific Title | The effects of alfa-cyclodextrin on the intestinal environment and endurance capacity of male university long-distance runners: A randomized, parallel-group, placebo-controlled trial |
| Date of disclosure of the study information | 2026/07/10 |
| Last modified on | 2026/07/10 10:48:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effects of alfa-cyclodextrin on the intestinal environment and endurance capacity
Acronym
The effects of alfa-cyclodextrin on the intestinal environment and endurance capacity
Scientific Title
The effects of alfa-cyclodextrin on the intestinal environment and endurance capacity of male university long-distance runners: A randomized, parallel-group, placebo-controlled trial
Scientific Title:Acronym
The effects of alfa-cyclodextrin on the intestinal environment and endurance capacity of male university long-distance runners: A randomized, parallel-group, placebo-controlled trial
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the effect of alfa-cyclodextrin supplementation on the intestinal environment and endurance capacity of male university long-distance runners.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The intestinal environment
Key secondary outcomes
Endurance capacity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
alfa-cyclodextrin 1 g/day, 4 weeks
Interventions/Control_2
alfa -cyclodextrin 2 g/day, 4 weeks
Interventions/Control_3
Placebo, 4 weeks
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. University student
2. Male athletes belonging to the track and field club's long-distance division
3. Individuals capable of completing all study procedures, including supplementation and measurements
4. Individuals who fully understand the study after receiving a thorough explanation and have provided written informed consent
Key exclusion criteria
1. Individuals with a history or current diagnosis of severe cardiac, hepatic, renal, or gastrointestinal disease.
2. Individuals with a known allergy to the investigational product (or its ingredients).
3. Individuals currently participating in another clinical trial of a food product or pharmaceutical, or who have participated in one within 4 weeks prior to screening.
4. Individuals who plan to change their club affiliation or competitive discipline, or to suspend their athletic activities (e.g., due to leaves of absence or retirement) during the study period.
5. Individuals who have undergone major surgery (e.g., colonoscopic surgery, cholecystectomy, or gastric bypass) that could affect gastrointestinal structure, function, or study outcomes within 6 months prior to obtaining informed consent.
6. Individuals judged by the principal investigator or sub-investigator to be unsuitable for participation in this study for any other reason.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Suzuki |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
2701695
Address
1-1 Hirakagakuendai, Inzai, Chiba, Japan
TEL
+81-476-98-1001
yssuzuki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yoshio |
| Middle name | |
| Last name | Suzuki |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
2701695
Address
1-1 Hirakagakuendai, Inzai, Chiba, Japan
TEL
0476981001
Homepage URL
yssuzuki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Yoshio Suzuki
Funding Source
Organization
Japan Sports Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Metagen, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee, Juntendo University, Graduate School of Health and Sports Science
Address
1-1 Hirakagakuendai, Inzai, Chiba, Japan
Tel
+81-476-98-1001
sc-gradkyomu@juntendo.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 | 07 | Month | 10 | 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
36
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 | 06 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 15 | 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 | 07 | Month | 10 | Day |
Last modified on
| 2026 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071179
