UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048593
Receipt number R000055361
Scientific Title Effects of consumption of the test food on the oral environment in healthy subjects: a double-blind, crossover comparison trial
Date of disclosure of the study information 2022/08/04
Last modified on 2023/07/03 08:46:29

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Basic information

Public title

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

Acronym

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

Scientific Title

Effects of consumption of the test food on the oral environment in healthy subjects: a double-blind, crossover comparison trial

Scientific Title:Acronym

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

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Plaque index

Key secondary outcomes

Oral flora


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

<Period I>
Duration: Three days
Test food: Chewable tablet containing proanthocyanidins derived from Acacia Bark
Administration: Take one tablet with not chewing but licking three times a day after every meal

<Period II>
Duration: Three days
Test food: Placebo chewable tablet
Administration: Take one tablet with not chewing but licking three times a day after every meal

*Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
*The intervention sequence is Period I to Period II.

Interventions/Control_2

<Period I>
Duration: Three days
Test food: Placebo chewable tablet
Administration: Take one tablet with not chewing but licking three times a day after every meal

<Period II>
Duration: Three days
Test food: Chewable tablet containing proanthocyanidins derived from Acacia Bark
Administration: Take one tablet with not chewing but licking three times a day after every meal

*Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
*The intervention sequence is Period I to Period II.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Adults

4. Healthy subjects

5. Subjects whose plaque index is high at screening (before consumption)

6. Subjects who are judged as eligible to participate in the study by the physician

Key exclusion criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily

5. Subjects who are currently taking medications (including herbal medicines) and supplements

6. Subjects who are allergic to medicines and/or the test food related products

7. Subjects who use artificial tooth, post crowns, dentures, implants or bridges

8. Subjects who are undergoing medical treatment for periodontosis or dental caries

9. Subjects who use dental floss, interdental brush, or mouthwash when brushing their teeth

10. Subjects who have received dental maintenance care (such as removing dental plaques or dental tartars) at the dental clinic within the last three months

11. Subjects who have diseases associated with salivary gland such as dry mouse and salivary stone disease

12. Subjects who are pregnant, lactation, or planning to become pregnant during this trial

13. Subjects who suffer from COVID-19

14. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

15. Subjects who are judged as ineligible to participate in this study by the physician

Target sample size

5


Research contact person

Name of lead principal investigator

1st name Masahiko
Middle name
Last name Horiuchi

Organization

Medical Corporation Yuseikai, Horiuchi Dental Clinic

Division name

Director

Zip code

141-0022

Address

2F AM Bldg., 2-3-3, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

TEL

03-3449-1033

Email

dr_horiuchi@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

Acacia-No-Ki Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Medical Corporation Yuseikai, Horiuchi Dental 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

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

医療法人社団優正会 堀内歯科医院 (東京都)
Medical Corporation Yuseikai, Horiuchi Dental Clinic (Tokyo, Japan)


Other administrative information

Date of disclosure of the study information

2022 Year 08 Month 04 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

5

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

2022 Year 07 Month 20 Day

Date of IRB

2022 Year 07 Month 20 Day

Anticipated trial start date

2022 Year 08 Month 04 Day

Last follow-up date

2022 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 08 Month 04 Day

Last modified on

2023 Year 07 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055361


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name