Unique ID issued by UMIN | UMIN000045256 |
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Receipt number | R000051664 |
Scientific Title | An exploratory study on the effect of a gummy candy intake on salivary secretion. |
Date of disclosure of the study information | 2021/08/25 |
Last modified on | 2022/03/16 14:18:47 |
An exploratory study on the effect of a gummy candy intake on salivary secretion.
An exploratory study on the effect of a gummy candy intake on salivary secretion.
An exploratory study on the effect of a gummy candy intake on salivary secretion.
An exploratory study on the effect of a gummy candy intake on salivary secretion.
Japan |
Healthy adults
Adult |
Others
NO
The study aims to exploratory investigate whether an acidulants- and flavors-supplemented gummy candy influences the secretion volume and the secretion rate of saliva on postmenopausal females who decreased salivary secretion, in comparison with chewing gum.
Safety,Efficacy
Exploratory
The volume of saliva secreted
The rate of salivary secretion
Salivary IgA (s-IgA)
Subjective questionnaire
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
2
Prevention
Food |
Take one gummy candy at once.
Take one chewing gum at once.
50 | years-old | <= |
65 | years-old | >= |
Female
1. Those who were given sufficient explanations of the trial information, and signed the document of the informed consent with well understanding of the trial objective; also, those who voluntarily joined the trial.
2. Healthy females aged between 50 to 65.
3. Postmenopausal females.
4. Those who have the volume of saliva secreted between 2-6 g are assessed by the Saxon test.
1. Those who cannot intake gummy candies or chewing gums, because of any reasons (e.g. preference for the foods, or under dental treatment, etc).
2. Those who have food allergies.
3. Those who have a smoking habit, or those who had a smoking habit within 1 year before this study.
4. Those who have any severe or progressive diseases.
5. Those who were diagnosed with dry mouth by medical doctors.
6. Those who have been taking foods and supplements to obtain health benefits over 5 times every week and/or over 1 month.
7. Those who take calcium channel blockers, hypnotics, anti-anxiety agents, or anti-depressive agents.
8. Those who joined other clinical trials or monitoring surveys (limited to the trials which are accompanied with oral intake or oral administration) within 1 month before obtaining informed consent on this study.
9. Those who are planning extremely change their lifestyle (such as diet, sleep, or exercise) during the trial period.
10. Those who are unsuitable for this study that judged by the principal investigator.
22
1st name | Yoshitada |
Middle name | |
Last name | Hira |
IMEQRD Co., Ltd
Sales department
104-0061
6-2-1 Ginza Chuo-ku Tokyo Japan
03-6704-5968
y-hira@imeqrd.co.jp
1st name | Hirokuni |
Middle name | |
Last name | Kayama |
IMEQRD Co., Ltd
Sales department
104-0061
6-2-1 Ginza Chuo-ku Tokyo Japan
03-6704-5968
h-kayama@imeqrd.co.jp
IMEQRD Co., Ltd
Meiji Co., Ltd
Profit organization
CPCC Company Limited
Chiyoda Oralhealth Care Clinic
Meiji Co., Ltd
Suda Clinic institutional review board
2-8-14,Takadanobaba,Shinjyuku,Tokyo
03-6704-5968
n-yuzawa@imeqrd.co.jp
NO
2021 | Year | 08 | Month | 25 | Day |
Unpublished
Completed
2021 | Year | 08 | Month | 10 | Day |
2021 | Year | 07 | Month | 27 | Day |
2021 | Year | 09 | Month | 27 | Day |
2021 | Year | 10 | Month | 04 | Day |
2021 | Year | 08 | Month | 25 | Day |
2022 | Year | 03 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051664
Research Plan | |
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