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	2025/08/01 23:03:47

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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

Oral candidiasis

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

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

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

No need to know

Intervention

No. of arms

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Taking sea cucumber jelly twice a day for two weeks.

Interventions/Control_2

Taking the control jelly, which does not contain sea cucumber ingredients, twice a day for two 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

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

Email

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

Email

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

Email

takashi.kondou@j.iwate-med.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2020 Year 07 Month 15 Day

Related information

URL releasing protocol

No URL is available.

Publication of results

Unpublished

Result

URL related to results and publications

Results are not published because data do not support the hypothesis (negative data was obtained).

Number of participants that the trial has enrolled

Results

For elderly, there was no difference in oral fungal counts after taking both sea cucumber jelly (test) and control jelly. In addition, although there was a significant increase in streptococci only in the control group. Oral moisture levels also improved in the control group.
In a subsequent survey conducted on healthy adults, similar results as the survey for elderly was shown. Therefore, the oral environment-improving effects of the sea cucumber components in the jelly were not observed.

Results date posted

2025 Year 08 Month 01 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participants from elderly care facilities:
Participants were selected from elderly with a care level of 2 or higher. A briefing session on the research content was held for facility staff, and facility staff (care managers and nurses) were asked to select candidates who could participate in the study. Subsequently, the applicant or facility manager explained the study to the candidates based on the explanatory document, and those who provided written consent were selected as participants. A total of 30 participants were enrolled, and there were no dropouts.
Participants from adult care facilities:
Information sessions about the study were conducted for facility staff, and participants who provided written consent were included. Minors and individuals undergoing ongoing treatment for systemic diseases were excluded. A total of 28 participants were enrolled, with 2 dropouts. Both dropouts were assigned to the sea cucumber jelly intake group, as determined during analysis.

Participant flow

There were 30 participants in the elderly care facility, and no one was excluded from the baseline data after registration. The participants were randomly assigned to the test group and the control group in groups of 15. No one dropped out after the start of the trial.
There were 28 participants at the workplace, and no one was excluded from the baseline data after registration. After registration, 14 participants were randomly assigned to the experimental group and the control group. Two participants dropped out after the trial began. At the time of analysis, it was found that both of these participants had been assigned to the sea cucumber jelly intake group.

Adverse events

No adverse events occurred.

Outcome measures

The numbers and the numbers in parentheses after them indicate the mean and standard deviation.
The test results at the elderly care facility were as follows.
1. Oral streptococcus count (log CFU)
　　　　　　　　　　　　　 Base　　　 After intake p-value (t-test)
Sea cucumber jelly group (N=15) 4.16 (0.50) 4.39 (0.39)　　0.153
Control group (N=15) 4.14 (0.48) 4.66 (0.30) <0.01

2. Oral fungal count (log CFU)
　　　　　　　　　　 Base　　　After intake p-value (Wilcoxon test)
Sea cucumber jelly group (N=15) 1.84 (0.58) 1.89 (0.79) 0.865
Control group (N=15) 1.69 (0.82) 1.48 (0.92) 0.382

3. Oral moisture level (oral moisture meter Mucus Score)
　　　　　　　　　　 Base　　　 After intake p-value (t-test)
Sea cucumber jelly group (N=14) 26.9 (3.24) 23.9 (5.10)　　0.098
Control group (N=14) 28.4 (2.22) 24.8 (5.10) 0.032

4. Oral Health Assessment Tool (OHAT) Score
Base　　　 After intake p-value (Wilcoxon test)
Sea cucumber jelly group (N=15) 2.53 (2.23) 3.67 (2.53)　　0.019
Control group (N=15) 4.60 (2.70) 4.93 (2.43) 0.472

5. BMI <body Mass Index>
Base　　　　　After intake p-value (t-test)
Sea cucumber jelly group (N=15) 21.6 (3.04) 21.7 (3.02)　　 0.807
Control group (N=15) 20.5 (3.22) 20.7 (3.22) 0.079

Significant differences were observed in all outcome measures in the baseline data between healthy adults and elderly care facilities, so the research results are presented separately. The results at the workplace were as follows. Note that OHAT was not evaluated in healthy adults, and BMI was recorded only at baseline.

1. Oral Streptococcus quantity (log CFU)
　　　　　　　　　　 Base　　　 After intake p-value (t-test)
Sea cucumber jelly group (N=12) 6.06 (0.98) 6.68 (0.43)　　0.089
Control group (N=14) 6.06 (0.33) 6.81 (0.38) <0.01

2. Oral fungal count (log CFU)
　　　　　　　　　　 Base　　　　After intake p-value (Wilcoxon test)
Sea cucumber jelly group (N=12) 0.57 (0.72) 0.57 (0.71) 0.893
Control group (N=14) 0.49 (0.69) 0.72 (0.68) 0.866

3. Oral Moisture Level
　　　　　　　　　　 Base After intake p-value (t-test)
Sea Cucumber Jelly Group (N=12) 25.6 (3.36) 26.9 (2.51)　　0.339
Control group (N=14) 26.2 (2.13) 26.9 (1.52) 0.275

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

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 06 Month 20 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.
Subsequently, a similar clinical trial was conducted between 1 May and 20 May 2023 on 26 healthy adults working at one workplace. The results showed that there were no differences between the groups or before and after consumption in the oral microbiota after two weeks of consuming sea cucumber-containing jelly and control jelly.

Management information

Registered date

2020 Year 07 Month 13 Day

Last modified on

2025 Year 08 Month 01 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046922