UMIN-CTR Clinical Trial

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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