UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037161 |
|---|---|
| Receipt number | R000042341 |
| Scientific Title | Study on relationship between sweet preference and stress or fatigue |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2019/06/25 11:17:51 |
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Basic information
Public title
Relationship between sweet preference and stress or fatigue
Acronym
Mental condition and sweet preference
Scientific Title
Study on relationship between sweet preference and stress or fatigue
Scientific Title:Acronym
Relationship between sweet preference and stress or fatigue
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Frequent intake of sugar-containing foods is a major risk factor for dental caries. Since it is generally regarded that appetite for sweet foods is increased by stress, stressed condition may lead to risks for dental caries and excess intake of sugar. However, the studies clarifying impacts of stress or fatigue on sweet preference are scarce. Therefore, the aim of the present study is to elucidate how the sensitivity and preference to sweetness will be changed by stress or fatigue.
Basic objectives2
Others
Basic objectives -Others
To discuss measures against increased intake of sweetness induced by stress from the viewpoint of oral health
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Recognition threshold for sucrose and preference levels to 8 step concentrations of sucrose solutions
Key secondary outcomes
Salivary alpha-amylase activity and subjective evaluation of stress and fatigue
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Implementation of Kaepelin test/Without Kaepelin test
Interventions/Control_2
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
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy adult women
Key exclusion criteria
Individuals with problems of taste and smell functions and internal medication affecting glycometabolism
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naomi |
| Middle name | |
| Last name | Yoshida |
Organization
Tokyo Medical and Dental University
Division name
Department of Oral Health Care Education, Graduate School of Medical and Dental Sciences
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4646
yoshida.ohce@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Sugimoto |
Organization
Tokyo Medical and Dental University
Division name
Department of Oral Health Care Education, Graduate School of Medical and Dental Sciences
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4850
Homepage URL
ksugimoto.bohs@tmd.ac.jp
Sponsor or person
Institute
Department of Oral Health Care Education,
Graduate School of Medical and Dental Sciences,
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Faculty of Dentistry, Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5404
d-hyoka.adm@tmd.ac.jp
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
東京医科歯科大学歯学部口腔保健学科/School of Oral Health Care Sciences, Faculty of Dentistry, Tokyo Medical and Dental University
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 25 | Day |
Last modified on
| 2019 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042341
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
