UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060632 |
|---|---|
| Receipt number | R000069350 |
| Scientific Title | Effects of mouthwash on oral nitrate metabolism and exercise performance |
| Date of disclosure of the study information | 2026/02/10 |
| Last modified on | 2026/02/09 22:25:20 |
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Basic information
Public title
Effects of mouthwash on oral nitrate metabolism and physical fitness
Acronym
Effects of mouthwash on oral nitrate and physical fitness
Scientific Title
Effects of mouthwash on oral nitrate metabolism and exercise performance
Scientific Title:Acronym
Effects of mouthwash on oral nitrate and performance
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to evaluate the effects of mouthwash use on salivary flora, salivary nitrate metabolites, blood nitrate metabolites, and exercise performance in healthy young men.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum oxygen uptake measured before and after 28 days of mouthwash
Key secondary outcomes
Nitrate metabolites measured before and after 28 days of mouthwash, blood parameters measured before and after 28 days of mouthwash,heart rate measured before and after 28 days of mouthwash, ratings of perceived exertion measured before and after 28 days of mouthwash, blood pressure measured before and after 28 days of mouthwash
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
By using active mouthwash for 28 days (3 times/day), exercise testing conducts on the first and final days. Washout more than 4 weeks. By using placebo mouthwash for 28 days (3 times/day), exercise testing conducts on the first and final days.
Interventions/Control_2
By using placebo mouthwash for 28 days (3 times/day), exercise testing conducts on the first and final days. Washout more than 4 weeks. By using active mouthwash for 28 days (3 times/day), exercise testing conducts on the first and final days.
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
Key inclusion criteria
1. Participants who are aged 60-79 years old
2. Male participants.
3. Participants who have no chronic disorders.
4. Participants who have no use of prescribed medication and supplements
5. Participants who are non-smokers.
6. Participants who have not gained or reduced weight in the past 3 months or who will not intend to lose weight within the examination period.
7. Not participating in other studies while they are participating in the present study.
8. Participants who have exercise habits (at least 30 min per session for 2 times a week).
9. Participants who are not allergic to commercially available mouthwashes or toothpastes
Key exclusion criteria
1. Participants who are not aged 60-79 years old
2. Female participants.
3. Participants who have chronic disorders.
4. Participants who have use of prescribed medication and supplements
5. Participants who are smokers.
6. Participants who have gained or reduced weight in the past 3 months or who will intend to lose weight within the examination period.
7. Participating in other studies while they are participating in the present study.
8. Participants who have no exercise habits (at least 30 min per session for 2 times a week).
9. Participants who are nallergic to commercially available mouthwashes or toothpastes
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | MIyashita |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6774
m.miyashita@waseda.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Miyashita |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6774
Homepage URL
m.miyashita@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Waseda University
Address
1-104 Totsuka-cho, Shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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 | 02 | 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
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
| 2025 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | 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 | 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=R000069350
