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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042921
Receipt No. 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 2021/01/06

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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
Email 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
Email satou_shouta@lotte.co.jp

Sponsor
Institute LOTTE Co., Ltd.
Institute
Department

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
Email 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
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
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 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 01 Month 06 Day
Last modified on
2021 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048903

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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