UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053749 |
|---|---|
| Receipt number | R000061262 |
| Scientific Title | Effect of Intake of the Test Food on the Oral Environment in Healthy Subjects. |
| Date of disclosure of the study information | 2024/03/03 |
| Last modified on | 2024/04/01 10:35:22 |
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Basic information
Public title
Effect of Intake of the Test Food on the Oral Environment in Healthy Subjects.
Acronym
Effect of Intake of the Test Food on the Oral Environment in Healthy Subjects.
Scientific Title
Effect of Intake of the Test Food on the Oral Environment in Healthy Subjects.
Scientific Title:Acronym
Effect of Intake of the Test Food on the Oral Environment in Healthy Subjects.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines effect of intake of the test food on the oral environment in healthy subjects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
* Evaluation indexes related to the oral environment
(Screening, Week 0, Week 4)
Key secondary outcomes
* Secondary outcome
1) Evaluation items related to halitosis (Week 0, Week 4)
2) Visual Analogue Scale (Screening, Week 0, Week 4)
* Safety indexes
1) Doctor's questions (Screening, Week 0, Week 4)
2) Side effects and adverse events (Week 4)
3) Subject's diary (From the first day of intake of a test material to the last day of the test.)
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test food (1 tablet in a day; 4 weeks).
Interventions/Control_2
Oral intake of the placebo food (1 tablet in a day; 4 weeks).
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 20-64 years at the time of obtaining consent to participate in the study.
2) Individuals who have a feeling of stinging in their teeth when eating or drinking cold or sweet foods.
3) Individuals who are concerned about halitosis.
4) Individuals who brush their teeth less than twice a day.
5) Individuals who have be given sufficient explanation about the purpose and contents of this study, volunteer for voluntary participation with good understanding, and can consent to the study.
6) Individuals who can come to the designated venue for this study and be inspected.
7) Individuals who are approved by the responsible doctor as appropriate to participate in this study.
Key exclusion criteria
1) Individuals using medical products.
2) Individuals with oral diseases that require treatment such as caries or periodontal disease.
3) Individuals with a history of current illness or serious illness such as mental illness, hypertension, diabetes, lipid abnormality, Sjoegren syndrome, or rheumatism.
4) Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
5) Individuals who are a patient or have a history of or endocrine disease.
6) Individuals who have had a habit of taking antibiotics or drugs for disease treatment in the past month.
7) Individuals currently undergoing dental treatment for periodontal disease, caries, or dry mouth.
8) Individuals with dentures, false teeth, or implants (numbers 6 to 8 are acceptable for both upper and lower jaws).
9) Individuals who have had plaque and tartar removed at a dental clinic within the past six months.
10) Individuals who have the habit of using interdental brushes, floss, mouthwash, etc. when brushing their teeth.
11) Individuals who are a smoker.
12) Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
13) Individuals who are sensitive to test food or other foods, and medical products.
14) Individuals with possible changes of lifestyle during the test period.
15) Individuals who have a habit of continuously taking vitamins, foods containing lactic acid bacteria and bifidobacteria, foods with functional claims, health foods, and supplements, or who plan to take them during the test period.
16) Individuals who are pregnant, lactating, or who may become pregnant during the test period.
17) Individuals who participated in other clinical studies in the past 3 months.
18) Individuals who are or whose family is engaged in a company that develops, manufactures, or sells foods with health and functional claims and cosmetics.
19) Individuals judged inappropriate for the study by the responsible doctor.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Jiro |
| Middle name | |
| Last name | Seto |
Organization
NISSIN FOODS HOLDINGS CO., LTD.
Division name
Health Science Research Division
Zip code
192-0001
Address
2100 Tobukimachi, Hachioji-shi, Tokyo 192-0001, JAPAN
TEL
+81-80-3586-5345
jiro.seto@nissin.com
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
NISSIN FOODS HOLDINGS CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
NISSIN FOODS HOLDINGS 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.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
| 2024 | Year | 03 | Month | 03 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061262
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