UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047976 |
|---|---|
| Receipt number | 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 | 2023/05/09 16:17:52 |
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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
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
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054428
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