UMIN-CTR Clinical Trial

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
Email	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
Email	ksugimoto.bohs@tmd.ac.jp

Sponsor
Institute	Department of Oral Health Care Education, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042341