UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049263 |
|---|---|
| Receipt number | R000056104 |
| Scientific Title | Quantitative evaluation of facilitating salivary secretion effect of yogurt intake, and an exploratory study of its alleviating effects on physical and psychological conditions. |
| Date of disclosure of the study information | 2022/10/22 |
| Last modified on | 2023/10/20 09:20:34 |
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Basic information
Public title
Quantitative evaluation of facilitating salivary secretion effect of yogurt intake, and an exploratory study of its alleviating effects on physical and psychological conditions.
Acronym
The effect of yogurt on salivary secretion.
Scientific Title
Quantitative evaluation of facilitating salivary secretion effect of yogurt intake, and an exploratory study of its alleviating effects on physical and psychological conditions.
Scientific Title:Acronym
The effect of yoghurt on salivary secretion.
Region
| Japan |
Condition
Condition
Men and women between the ages of 20 and 90.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the salivary secretion effect of yogurt and then evaluate exploratory its alleviating effects on physical and psychological conditions by comparing with water.
Basic objectives2
Others
Basic objectives -Others
To compare the salivation effect and physical/psychological relaxation effect of yogurt ingestion with water ingestion.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The number of dry swallows and dry swallow interval after eating yogurt.
Key secondary outcomes
Secondary outcomes
visual analogue scale,pulse rate,the number of uninstructed dry swallows and dry swallow interval.
Safety
number of adverse events, number of cases, frequency of occurrence, number of adverse events caused by research, number of cases, frequency of occurrence.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Drink water after yogurt
Interventions/Control_2
Drink yogurt after water
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Men and women between the ages of 20 and 90 on the date of informed consent for this study.
2. Those who have received a sufficient explanation of the purpose and content of this research, have the ability to consent, fully understand the content of the research, apply voluntarily, and agree to participate in writing.
Key exclusion criteria
1.Those who participated in other clinical research from the online participation application to the day of the research.
2.Subjects who have not continued the same level of exercise as follows for 1 year or longer.
*Commuting, shopping, walking, etc. once a week, about 30 minutes a day.
*Housework such as cleaning and washing once a week for about 30 minutes a day.
3.Those who have the following medical history or current medical history.
*Cardiovascular disease.
*Respiratory disease.
*Walking dysfunction.
*Spasticity, rigidity, deformity of the lower extremities.
*Cerebral vascular disease, spinal cord disease, and other gait disorders caused by peripheral nerves.
*Epilepsy.
*Loss of consciousness seizure.
4.Subjects who have been diagnosed with a disorder related to swallowing.
5.Those who have restrictions on diet or water intake.
6.milk allergy.
7.Those who need assistance when coming to the office.
8.Those who do not like the test food.
9.Those who have difficulty wearing the GOKURI neckband.
10.Those who have difficulty understanding the instructions.
11.Subjects with a minimum resting pulse rate of less than 50 bpm and a maximum pulse rate of 150 bpm or more.
12.Others who are judged to be ineligible as research subjects by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Toyama |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo, 192-0919, Japan
TEL
042-632-5824
yoshio.toyama@meiji.com
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | HIsajima |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo, 192-0919, Japan
TEL
042-632-5824
Homepage URL
tomoko.hisajima@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Geriatrics and Gerontology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachioji, Tokyo, Japan
Tel
042-632-5900
MEIJI.IRB@meiji.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
PLIMES株式会社（茨城県）／PLIMES Co., Ltd. (Ibaraki)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
106
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
Main results already published
Date of protocol fixation
| 2022 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 11 | 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 | 10 | Month | 19 | Day |
Last modified on
| 2023 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056104
