UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041594
Receipt number R000047482
Scientific Title Effects of consumption of the test food on the oral cavity environment in healthy subjects: A randomized, double-blind, placebo-controlled, parallel-group comparison study
Date of disclosure of the study information 2020/08/28
Last modified on 2021/11/02 09:45:10

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Basic information

Public title

Effects of consumption of the test food on the oral cavity environment in healthy subjects

Acronym

Effects of consumption of the test food on the oral cavity environment in healthy subjects

Scientific Title

Effects of consumption of the test food on the oral cavity environment in healthy subjects: A randomized, double-blind, placebo-controlled, parallel-group comparison study

Scientific Title:Acronym

Effects of consumption of the test food on the oral cavity environment in healthy subjects

Region

Japan


Condition

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effects of consumption of the test food on the oral cavity environment in healthy subjects

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The number of periodontosis-related bacteria

Key secondary outcomes

1. The number of periodontosis-related bacteria
2. Assessment of periodontosis
3. The number of dental caries-related bacteria
4. Halitosis
5. Oral moisture values
6. The volume of saliva
7. Salivary pH
8. Serum high-sensitivity CRP concentration
9. Salivary IgA
10. Original questionnaires


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



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: Four weeks
Test food: Active chewable tablet
Administration:
Examination at the start of the test-food consumption: To suck three tablets without chewing after the examination.
Between the day after the examination at the start of the test-food consumption and the day before the examination at four weeks after the start of the test-food consumption: To suck three tablets without chewing once a day at any time during the day

*If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_2

Duration: Four weeks
Test food: Placebo
Administration:
Examination at the start of the test-food consumption: To suck three tablets without chewing after the examination
Between the day after the examination at the start of the test-food consumption and the day before the examination at four weeks after the start of the test-food consumption: To suck three tablets without chewing once a day at any time during the day

*If you forget to take the test food, take it as soon as you remember within the day.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Healthy Japanese adult subjects

2. Subjects who are judged as healthy and eligible to participate in the study by the physician

3. Subjects who have a relatively large number of periodontosis-related bacteria at screening (before consumption)

Key exclusion criteria

Subjects who
1.undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction
2.have a pacemaker or an implantable cardioverter defibrillator (ICD)
3.undergoing treatment for cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4.use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily
5.currently taking medicines (include herbal medicines) and supplements
6.have used meperidine, hydrocodone, morphine, oxycontin, clonazepam, lorazepam, phenobarbital, or zolpidem
7.have used antibacterial drugs within the last 3 months before the invitation to participate in this trial
8.regularly use gargle medicine
9.use artificial tooth, post crowns, dentures, or implants
10.regularly use floss, interdental cleaner, and mouthwash
11.have receiving dental maintenance care at dental clinic, such as removing dental plaques and dental tartars within the last 3 months
12.have a medical history, current illness, or are suspected to be a Sjogren's syndrome
13.suffer from disorders associated with salivary gland such as dry mouse and salivary stone disease
14.whose salivary secretion volume at rest is less than 1.5 g/15 min
15.are under treatment of periodontosis or dental caries
16.undergoing treatment or diagnosed with any of dental diseases
17.are smokers, or started smoking cessation within a year before the invitation to participate in this trial
18.allergic to medications and/or the test food-related products
19.are lactating, pregnant, or intending to become pregnant
20.have been enrolled in other clinical trials within the last 3 months before the invitation to participate in this trial, or plan to participate in another trial during this trial
21.are judged by the principal investigator as ineligible to participate in the trial

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Kazuo
Middle name
Last name YAMAMOTO

Organization

ORTHOMEDICO Inc.

Division name

CEO

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Email

kazu@orthomedico.jp


Public contact

Name of contact person

1st name Naoko
Middle name
Last name SUZUKI

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Homepage URL


Email

nao@orthomedico.jp


Sponsor or person

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name



Funding Source

Organization

TOKIWA PHYTOCHEMICAL Co., Ltd.


Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Medical Corporation Yuseikai, Horiuchi Dental Clinic

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)



IRB Contact (For public release)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.

Tel

03-5793-3623

Email

IRB@takara-clinic.com


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 08 Month 28 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

44

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

2020 Year 08 Month 21 Day

Date of IRB

2020 Year 08 Month 21 Day

Anticipated trial start date

2020 Year 08 Month 27 Day

Last follow-up date

2020 Year 12 Month 25 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 08 Month 28 Day

Last modified on

2021 Year 11 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047482


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name