UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042921 |
|---|---|
| Receipt number | R000048903 |
| Scientific Title | Measurement of salivary pH while chewing gum containing acidulant. -2 step crossover single blind controlled trial- |
| Date of disclosure of the study information | 2021/01/06 |
| Last modified on | 2021/07/08 10:25:05 |
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Basic information
Public title
Measurement of salivary pH while chewing gum containing acidulant.
Acronym
Effect of gum acidulant on saliva pH.
Scientific Title
Measurement of salivary pH while chewing gum containing acidulant. -2 step crossover single blind controlled trial-
Scientific Title:Acronym
Measurement of salivary pH while chewing gum containing acidulant.
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether gum containing acidulant lowers salivary pH during chewing below 5.7.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Salivary pH
Key secondary outcomes
Salivary weight
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of the gum 1 containing acidulant.
Interventions/Control_2
Single intake of the gum 2 containing acidulant.
Interventions/Control_3
Single intake of the gum 3 containing acidulant.
Interventions/Control_4
Single intake of the gum 4 containing acidulant.
Interventions/Control_5
Single intake of the gum 5 containing acidulant.
Interventions/Control_6
Single intake of the gum 6 containing acidulant.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Males and females whose age is between 20 and 60 years old
2) Subjects who can prohibit themselves from taking alcohol on the day before trial
3) Subjects who can sleep enough on the day before trial and keep their regular conditions
Key exclusion criteria
1) Female subjects who are pregnant or lactating, or intending to become pregnant during the study
2) Subjects who have the possibility of developing allergic symptoms by the test food
3) Subjects who have a fever or complain of illness
4) Subjects who have difficulty chewing gum ordinarily (80 times/min)
5) Subjects who have meal or snack within 1 hour before the trial starts
6) Subjects who have a potential of Sjogren's syndrome (whose salivary flow late is below 1 mL/min)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoko |
| Middle name | |
| Last name | Okuyama |
Organization
LOTTE Co., Ltd.
Division name
Central Laboratory Basic Research Department Health Science Section
Zip code
336-8601
Address
3-1-1, Numakage, Minami-ku, Saitama
TEL
048-837-0170
okuyama_satoko@lotte.co.jp
Public contact
Name of contact person
| 1st name | Shouta |
| Middle name | |
| Last name | Satou |
Organization
LOTTE Co., Ltd.
Division name
Central Laboratory Health Basic Research Department Science Section
Zip code
336-8601
Address
3-1-1, Numakage, Minami-ku, Saitama
TEL
048-837-0170
Homepage URL
satou_shouta@lotte.co.jp
Sponsor or person
Institute
LOTTE Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
LOTTE Co., Ltd.
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
Ethical Committee of Shiba Palace clinic
Address
DaiwaA Hamamatsucho Building 6F, 1-9-10 Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1590
jimukyoku@mail.souken-r.com
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
株式会社ロッテ中央研究所(埼玉県)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 06 | 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
20
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
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 11 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 11 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 11 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 06 | Day |
Last modified on
| 2021 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048903
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
