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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020765
Receipt No. R000023966
Scientific Title Influence of deliciousness on higher brain functions
Date of disclosure of the study information 2016/01/28
Last modified on 2016/01/31

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Basic information
Public title Influence of deliciousness on higher brain functions
Acronym Influence of deliciousness on higher brain functions
Scientific Title Influence of deliciousness on higher brain functions
Scientific Title:Acronym Influence of deliciousness on higher brain functions
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Medicine in general Neurology Rehabilitation medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The present research used a mental arithmetic test to evaluate the influence on higher brain functions when chewing gum that included taste components perceived as "delicious", as compared to gum including taste components considered as "not delicious", thereby investigating whether changes in the deliciousness of food changes higher brain functions in a short period of time.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes mental arithmetic test
Key secondary outcomes sensory test (visual analog scale)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food Behavior,custom
Interventions/Control_1 Arithmetic test after delicious gum chewing
Interventions/Control_2 Arithmetic test after non-delicious gum chewing
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
60 years-old >
Gender Male and Female
Key inclusion criteria Healthy jaws and teeth who could continuously chew gum
Key exclusion criteria A person who has not obtained the informed consent
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoko Hasegawa
Organization Hyogo College of Medicine
Division name Department of Dentistry and Oral & Maxillofacial Surgery
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL +81-798456677
Email cem17150@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoko Hasegawa
Organization Hyogo College of Medicine
Division name Department of Dentistry and Oral & Maxillofacial Surgery
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL +81-798-45-6677
Homepage URL
Email cem17150@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 28 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 No longer recruiting
Date of protocol fixation
2014 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 27 Day
Last modified on
2016 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023966

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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