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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048593
Receipt No. 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 2022/08/04

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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
Institute ORTHOMEDICO Inc.
Institute
Department

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
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
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
2022 Year 08 Month 04 Day


Link to view the page
URL(English) 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


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