Unique ID issued by UMIN | UMIN000048593 |
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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 |
Effects of consumption of the test food on the oral environment in healthy subjects
Effects of consumption of the test food on the oral environment in healthy subjects
Effects of consumption of the test food on the oral environment in healthy subjects: a double-blind, crossover comparison trial
Effects of consumption of the test food on the oral environment in healthy subjects
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effect of consumption of the test food on the oral environment in healthy Japanese subjects
Efficacy
Confirmatory
Pragmatic
Not applicable
Plaque index
Oral flora
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
Institution is not considered as adjustment factor.
2
Treatment
Food |
<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.
<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.
18 | years-old | <= |
Not applicable |
Male and Female
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
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
5
1st name | Masahiko |
Middle name | |
Last name | Horiuchi |
Medical Corporation Yuseikai, Horiuchi Dental Clinic
Director
141-0022
2F AM Bldg., 2-3-3, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-3449-1033
dr_horiuchi@orthomedico.jp
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
Acacia-No-Ki Co.,Ltd.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Medical Corporation Yuseikai, Horiuchi Dental Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
IRB@takara-clinic.com
NO
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)
2022 | Year | 08 | Month | 04 | Day |
Unpublished
5
Completed
2022 | Year | 07 | Month | 20 | Day |
2022 | Year | 07 | Month | 20 | Day |
2022 | Year | 08 | Month | 04 | Day |
2022 | Year | 09 | Month | 30 | Day |
2022 | Year | 08 | Month | 04 | Day |
2023 | Year | 07 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055361
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