UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044473 |
|---|---|
| Receipt number | R000050503 |
| Scientific Title | Verification of test food-ingesting effects on saliva-related parameters |
| Date of disclosure of the study information | 2021/07/20 |
| Last modified on | 2021/07/26 13:24:15 |
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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
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
s-kawakami-jf@morinaga.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050503
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| Registered date | File name |
| Research case data | |
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