UMIN-CTR Clinical Trial

Basic information
Public title	A study of improvement effects on salivary secretion by ingesting a food ingredient.
Acronym	A study of improvement effects on salivary secretion by ingesting a food ingredient.
Scientific Title	A study of improvement effects on salivary secretion by ingesting a food ingredient.
Scientific Title:Acronym	A study of improvement effects on salivary secretion by ingesting a food ingredient.
Region	Japan

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

Objectives
Narrative objectives1	To confirm improvement effects on salivary secretion by ingesting a food ingredient for 8 weeks.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Salivary secretion
Key secondary outcomes	1. Comprehensive analysis of oral microbiome, and the number of oral bacteria 2. Salivary IgA, amylase, chromogranin A, cortisol, lactoferrin, lysozyme 3. Halitosis analysis 4. VAS 5. Short version of POMS2 6. OSA sleep inventory MA version 7. Pittsburg sleep questionnaire 8. NAD-metabolites in blood

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of the test food without chewing, before or after breakfast, one tablet a day.
Interventions/Control_2	Ingestion of the placebo food without chewing, before or after breakfast, one tablet a day.
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	50 years-old <=
Age-upper limit	65 years-old >=
Gender	Female
Key inclusion criteria	(1) Female subjects aged 50 to 65 years old when consent acquisition. (2) Postmenopausal subjects. (3) Subjects with resting salivary secretion of more than 1.5 g. (4) Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria	(1) Subjects who routinely use the health-specific/functional/supplementary/health foods which may affect this study (more than three times a week), and have any difficulty in stopping use after the consent. (2) Subjects who have used medicines which may affect this study, more than two days a week, and have any difficulty in limiting use during this study. (3) Subjects who are planning to visit the hospital for cavity protection or oral cleaning during this study. (4) Subjects who have been determined as dry mouth symptom and/or Sjogren's syndrome. (5) Subjects with smoking habit, now and/or within a year before this study. (6) Subjects who drink a lot of alcohol. (7) Subjects having some kind of serious/progressive disease and symptom. (8) Subjects with previous/present medical history of serious diseases in heart, liver, kidney and digestive organs. (9) Subjects with some kind of drug and/or food allergy. (10) Subjects who are now under another clinical study with a medicine/food, or took part in that within 4 weeks before this study, or will join that after giving informed consent to join this study. (11) Subjects who donated over 200 mL of their whole blood and/or blood components within a month before this study. (12) Subjects who donated over 400 mL of their whole blood within the last 4 months before this study. (13) Subjects who will be collected over 800 mL in total of their blood within 12 months, before and in this study. (14) Subjects who have been determined as ineligible for participation, by the principal/sub investigator's opinions.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Masashi Middle name Last name Morifuji
Organization	Meiji Holdings Co., Ltd.
Division name	Group Leader
Zip code	192-0919
Address	1-29-1 Nanakuni, Hachiouji, Tokyo192-0919, Japan
TEL	042-632-2680
Email	masashi.morifuji@meiji.com

Public contact
Name of contact person	1st name Makoto Middle name Last name Ichinohe
Organization	CPCC Company Limited
Division name	Clinical Planning Department
Zip code	103-0021
Address	4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL	03-6225-9001
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Meiji Holdings Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Chiyoda Oralhealth Care Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel	03-6225-9005
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	2022 Year 06 Month 22 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	2022 Year 03 Month 22 Day
Date of IRB	2022 Year 03 Month 18 Day
Anticipated trial start date	2022 Year 06 Month 13 Day
Last follow-up date	2022 Year 09 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 06 Month 07 Day
Last modified on	2022 Year 06 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054428

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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