UMIN-CTR Clinical Trial

Basic information
Public title	Verification of test food-ingesting effects on saliva-related parameters
Acronym	Verification of test food-ingesting effects on saliva-related parameters
Scientific Title	Verification of test food-ingesting effects on saliva-related parameters
Scientific Title:Acronym	Verification of test food-ingesting effects on saliva-related parameters
Region	Japan

Condition
Condition	Healthy male/female adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In order to examine some kind of effect by test food intakes on saliva-corresponding parameters
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Saliva-related parameters
Key secondary outcomes

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	Food
Interventions/Control_1	Single ingestion of the test food - single ingestion of the placebo food.
Interventions/Control_2	Single ingestion of the placebo food - single ingestion of the test food.
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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Healthy males and females aged over 20 to under 65 when informed consent. (2) Subjects with saliva secretion (Saxon method) of over 2 g to under 6 g at preliminary examination (3) Subjects who have received enough explanation and understood about this study, and who can obtain informed consent documents.
Key exclusion criteria	(1)Subjects equipped with full/partial dentures, or being in the process of straightening their teeth, or stinging their teeth by sweet foods. (2)Subjects who have been to the hospital for treatment or oral cleaning within one month prior to the beginning of the test, or those who are planning to visit the hospital before the end of the test. (3)Throughout this trial, subjects who have any difficulty in refraining from taking steadily (not less than 3 times a week) in the medicines, health-specific/functional/health foods (related to salivary secretion, halitosis control, and immunity), which might affect the test results. (4)Subjects falling into the habit of smoking (rough average: not less than 20 cigarettes/day) (5)Subjects with probable seasonal allergy just like pollinosis, during the test period. (6)Subjects whose life style will change during the test period. (7) Subjects receiving some kind of medical treatment (especially in Sjogren's syndrome etc.) (8)Subjects with previous/current medical history of digestive diseases (concerning the previous one, non-influential those in participating in this trial, may be accepted judging from the principal investigator.) (9)Subjects who were hospitalized and received treatment in the past 6 months, or will be hospitalized during the test period. (10)Pregnant, possibly pregnant, lactating women. (11)Subjects with previous/current medical history of serious diseases in heart, liver, kidney etc. (12)Subjects with excessive alcohol intakes (tentative average: more than 60 g/day in a week). (13)Subjects having drug/food allergy. (14)Subjects who are now under the other clinical trials with some kind of medicine/food, or participated in those within 4 weeks prior to this study, or are planning to join those after giving informed consent to take part in this study. (15)Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinion.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Toshihiro Middle name Last name Kawama
Organization	Morinaga & Co., Ltd.
Division name	Health Science and Research Center, R&D institute
Zip code	230-8504
Address	2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL	045-571-6140
Email	t-kawama-jb@morinaga.co.jp

Public contact
Name of contact person	1st name Shinpei Middle name Last name Kawakami
Organization	Morinaga & Co., Ltd.
Division name	Health Science and Research Center, R&D institute
Zip code	230-8504
Address	2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL	045-571-6140
Homepage URL
Email	s-kawakami-jf@morinaga.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Morinaga & Co., Ltd.
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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.co.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	2021 Year 07 Month 20 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	Completed
Date of protocol fixation	2021 Year 04 Month 19 Day
Date of IRB	2021 Year 04 Month 16 Day
Anticipated trial start date	2021 Year 06 Month 16 Day
Last follow-up date	2021 Year 06 Month 28 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 06 Month 08 Day
Last modified on	2021 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050503