UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043251 |
|---|---|
| Receipt number | R000049357 |
| Scientific Title | Measurement of oral temperature while eating chewing gums or tablets with wearing a mask. -Crossover open controlled trial- |
| Date of disclosure of the study information | 2021/02/05 |
| Last modified on | 2021/02/04 16:24:18 |
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Basic information
Public title
Measurement of oral temperature while eating chewing gums or tablets with wearing a mask.
Acronym
Effect of eating chewing gums or tablets on oral temperature.
Scientific Title
Measurement of oral temperature while eating chewing gums or tablets with wearing a mask. -Crossover open controlled trial-
Scientific Title:Acronym
Measurement of mouth temperature while eating chewing gums and tablets with wearing a mask.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measurement the change of oral temperature while eating chewing gums or tablets with wearing a mask.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
After wearing the mask for 3 minutes, measure changes in oral temperature around 30 seconds after eating the samples by infrared camera shooting.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
9
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Treatment of no intake or single intake of any of the samples No. 1 to 8 once for each. The order of intake is randomized and counterbalanced. There should be a washout period of drinking water and rest between treatments.
Two types of treatment are set as one set, and the intervention time is about 30 minutes. The number of intervention days is 3 to 5 days because 1 or 2 sets of measurements are taken per day.
Interventions/Control_2
Same as above except that the order of treatment is different from intervention No.1.
Interventions/Control_3
Same as above except that the order of treatment is different from intervention No.1 and 2.
Interventions/Control_4
Same as above except that the order of treatment is different from intervention No.1 to 3.
Interventions/Control_5
Same as above except that the order of treatment is different from intervention No.1 to 4.
Interventions/Control_6
Same as above except that the order of treatment is different from intervention No.1 to 5.
Interventions/Control_7
Same as above except that the order of treatment is different from intervention No.1 to 6.
Interventions/Control_8
Same as above except that the order of treatment is different from intervention No.1 to 7.
Interventions/Control_9
Same as above except that the order of treatment is different from intervention No.1 to 8.
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Healthy subjects who are males and females whose age is between 20 and 65 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 during the study.
2)Subjects with food allergies (gelatin).
3)Subjects who have a fever or complain of illness on test day.
4)Subjects who have difficulty chewing gum ordinarily. (80 times per minute)
5)Subjects who are not good at strong mint stimulation.
6)Subjects who have meal or snack within 1 hour before the trial starts.
Target sample size
15
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 JAPAN
TEL
048-837-0170
okuyama_satoko@lotte.co.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Ichikawa |
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 JAPAN
TEL
048-837-0170
Homepage URL
ichikawa_tomoya@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 JAPAN
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 | 02 | Month | 05 | 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
15
Results
After eating each chewing gums, a significant oral temperature decrease was confirmed compared to no intake.
Results date posted
| 2021 | Year | 02 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy subjects between the ages of 26 and 53. Average age: 35.7 years.
Male:10 subjects, female:5 subjects
Participant flow
Application for
volunteer, participation in exam briefing sessions, submission of consent forms, determination of
volunteer, schedule adjustment, measurement implementation for each test samples.
Adverse events
None
Outcome measures
After wearing the mask for 3 minutes, measure changes in oral temperature around 30 seconds after eating the samples by infrared camera shooting.
Plan to share IPD
The average values of the oral temperature changes were calculated for each sample, and if a significant difference was observed compared to each control, use infrared photos of the subject corresponding to the average value for promotion appeal.
IPD sharing Plan description
The average values of the oral temperature changes of 15 subjects were calculated for each sample, and if a significant difference of 5% was observed compared to each control, use infrared photos of the subject corresponding to the average value for promotion appeal.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 09 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 09 | Day |
Date trial data considered complete
| 2020 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 04 | Day |
Last modified on
| 2021 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049357
