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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047976
Receipt No. R000054428
Scientific Title A study of improvement effects on salivary secretion by ingesting a food ingredient.
Date of disclosure of the study information 2022/06/22
Last modified on 2022/06/27

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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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