UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041088 |
|---|---|
| Receipt number | R000046922 |
| Scientific Title | Evaluation of effects on oral micro-flora by continuous intake of jelly made sea cucumber. |
| Date of disclosure of the study information | 2020/07/15 |
| Last modified on | 2024/01/24 16:18:10 |
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Basic information
Public title
Evaluation of a jelly food made from sea cucumber on improvement of oral health.
Acronym
Evaluation tests of sea cucumber jelly.
Scientific Title
Evaluation of effects on oral micro-flora by continuous intake of jelly made sea cucumber.
Scientific Title:Acronym
Effects on oral micro-flora by sea cucumber jelly intake.
Region
| Japan |
Condition
Condition
Oral candidiasis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We attempt to assess the positive effects of continuous intake of jelly food made from sea cucumber on oral micro flora.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After daily intake of test food for 2 weeks, the followings are assessed;
Oral streptococci amounts
Oral Candida amounts
Oral wetness
Oral Health Assessment Tool score
BMI <Body Mass Index>
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test group: Taking test food twice a day for 2 weeks.
Interventions/Control_2
Control group: Taking placebo food twice a day for 2 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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Institutionalized elderly who take food by mouth.
Key exclusion criteria
Individuals assessed to be unsuitable for research participation by the facility staff.
Individuals who have low consent ability and cannot obtain consent from the main caregiver.
Individuals who refuses the test in spite of consent the main caregiver.
Individuals who are judged to be difficult by the facility staff to participate due to poor physical condition on the day of the survey.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | MITSUO |
| Middle name | |
| Last name | KISHI |
Organization
Iwate Medical University School of Dentistry
Division name
Division of Preventive Dentistry, Department of Oral Medicine
Zip code
0208505
Address
1-3-27 Chuo-Dori, Morioka, Iwate prefecture
TEL
019-651-5111
mkishi@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | MITSUO |
| Middle name | |
| Last name | KISHI |
Organization
Iwate Medical University School of Dentistry
Division name
Division of Preventive Dentistry, Department of Oral Medicine
Zip code
0208505
Address
1-3-27 Chuo-Dori, Morioka, Iwate prefecture
TEL
019-651-5111
Homepage URL
mkishi@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Iwate prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwate Medical University School of Dentistry
Address
1-3-27 Chuo-Dori, Morioka, Iwate prefecture
Tel
019-651-5111
takashi.kondou@j.iwate-med.ac.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
| 2020 | Year | 07 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A randomized controlled trial was conducted on 30 residents at a long-term care insurance facility between February 7 and 28, 2021.The 30 participants were divided into 2 groups. One group took jelly containing sea cucumber and another took control jelly twice a day for 2 weeks. After the ingestion of jelly, there was no significant differences in oral microorganisms amounts. Therefore, we are currently examining the ingredients of the test samples.
Management information
Registered date
| 2020 | Year | 07 | Month | 13 | Day |
Last modified on
| 2024 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046922
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
