UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029413 |
|---|---|
| Receipt number | R000033612 |
| Scientific Title | Effect of ingestion of test food on oral health: a randomized, double-blinded, placebo-controlled trial |
| Date of disclosure of the study information | 2017/10/10 |
| Last modified on | 2018/12/04 11:02:42 |
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Basic information
Public title
Effect of ingestion of test food on oral health: a randomized, double-blinded, placebo-controlled trial
Acronym
Effect of ingestion of test food on oral health: a randomized, double-blinded, placebo-controlled trial
Scientific Title
Effect of ingestion of test food on oral health: a randomized, double-blinded, placebo-controlled trial
Scientific Title:Acronym
Effect of ingestion of test food on oral health: a randomized, double-blinded, placebo-controlled trial
Region
| Japan |
Condition
Condition
Oral health
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of test food on oral health
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral condition (GI, PLI)
Key secondary outcomes
Salivary hemoglobin level, Number of periodontopathic bacteria and total bacteria, Dental health-related quality of life, Experience effects, Salivary multi-test system, Infectious diseases
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test food (high dose) for 12 weeks
Interventions/Control_2
Ingestion of test food (low dose) for 12 weeks
Interventions/Control_3
Ingestion of placebo for 12 weeks
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Aged from 30 to 64 years old
Key exclusion criteria
1) Subjects who have oral disease
2) Subjects who participated in other clinical studies in the past 1 month
3) Subjects who had treatment with antibiotics in the past 1 month, or ones who are expected to have treatment with antibiotics
4) Subjects with milk allergy
5) Subjects in pregnancy or breast-feeding
6) Subjects who have a history of serious disorders in liver, kidney, heart, lung, gastro-intestine, blood, endocrine system, or metabolic system etc.
7) Subjects who are judged inappropriate to this trial by the investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Yoshida |
Organization
Matsumoto Dental University
Division name
Department of Oral Microbiology
Zip code
Address
1780 Gobara Hiro-oka, Shiojiri, Nagano, 399-0781 Japan
TEL
0263-51-2082
aki@po.mdu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Yoshida |
Organization
Matsumoto Dental University
Division name
Department of Oral Microbiology
Zip code
Address
1780 Gobara Hiro-oka, Shiojiri, Nagano, 399-0781 Japan
TEL
0263-51-2082
Homepage URL
aki@po.mdu.ac.jp
Sponsor or person
Institute
Matsumoto Dental University
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
Address
Tel
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
| 2017 | Year | 10 | Month | 10 | 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
| 2017 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 04 | Day |
Last modified on
| 2018 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033612
