UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056143 |
|---|---|
| Receipt number | R000064136 |
| Scientific Title | Effects of long-term glutamine supplementation on athlete's immunity, inflammation, and oxidative stress |
| Date of disclosure of the study information | 2024/11/13 |
| Last modified on | 2024/11/13 16:50:20 |
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Basic information
Public title
Effects of long-term glutamine supplementation on athlete's immunity, inflammation, and oxidative stress
Acronym
Effects of long-term glutamine supplementation on athlete's immunity, inflammation, and oxidative stress
Scientific Title
Effects of long-term glutamine supplementation on athlete's immunity, inflammation, and oxidative stress
Scientific Title:Acronym
Effects of long-term glutamine supplementation on athlete's immunity, inflammation, and oxidative stress
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study examines the effects of long-term glutamine supplementation on immune function, inflammation, oxidative stress markers, and gut microbiome variations in athletes during competition and training periods
Basic objectives2
Others
Basic objectives -Others
Before and after the study, participants will undergo a maximal oxygen uptake test using a cycling ergometer and 75-80% of their maximum oxygen uptake (VO2 max) for 60 minutes. Respiratory gas parameters and heart rate will be measured at regular intervals during exercise, and participants' perceived exertion will be recorded at set intervals. Blood samples will be collected before and after exercise. Additionally, urine and fecal samples will be collected before and after the study, and saliva samples will be collected before, after, and during the study period. These biological samples will be analyzed for markers of immune, inflammation, and oxidative stress parameters. Participants will also complete questionnaires before, after, and during the study to monitor upper respiratory tract infections and symptoms of overtraining syndrome.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
immune, inflammation, oxidative stress markers / gut microbiome
Key secondary outcomes
VO2max
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
YES
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants will consume L-glutamine or placebo at a dose of 0.3 g/kg/day for 8 weeks, followed by a 4-week washout period, in a crossover trial lasting a total of 20 weeks.
Interventions/Control_2
Participants will consume L-glutamine or placebo at a dose of 0.3 g/kg/day for 8 weeks, followed by a 4-week washout period, in a crossover trial lasting a total of 20 weeks.
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
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy athletes aged 18-29
Key exclusion criteria
1. Abnormal findings on resting 12-lead electrocardiogram and/or blood pressure, Cannot limit drinking alcohol the day before the experiment, Smoking or taking antioxidant supplements, Taking anti-allergy agent or anti-inflammatory agent
2. Unable to participate in competitions or training due to injuries
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Suzuki |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6898
katsu.suzu@waseda.jp
Public contact
Name of contact person
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Suzuki |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6898
Homepage URL
katsu.suzu@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Katsuhiko Suzuki
Funding Source
Organization
Waseda University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office of Research Ethics, Waseda University
Address
1-104 Totsuka-cho Shinjyuku-Ku, Tokyo
Tel
03-5272-4652
rps-management@list.waseda.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2024-342
Org. issuing International ID_1
Office of Research Ethics, Waseda University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 13 | 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
| 2024 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 07 | 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
| 2024 | Year | 11 | Month | 13 | Day |
Last modified on
| 2024 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064136
