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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046576
Receipt No. R000053137
Scientific Title Effects of taste stimulation by Japanese beef (chuck short ribs): A crossover test
Date of disclosure of the study information 2022/01/07
Last modified on 2022/01/07

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Basic information
Public title Effects of taste stimulation by Japanese beef (chuck short ribs): A crossover test
Acronym Effects of taste stimulation by Japanese beef (chuck short ribs): A crossover test
Scientific Title Effects of taste stimulation by Japanese beef (chuck short ribs): A crossover test
Scientific Title:Acronym Effects of taste stimulation by Japanese beef (chuck short ribs): A crossover test
Region
Japan

Condition
Condition Healthy person
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to clarify the effects of taste stimulation by small amounts of Japanese beef (chuck short ribs) using physiological and psychological indicators in female undergraduate and graduate students.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Prefrontal activity using near-infrared spectroscopy
2) Sympathetic and parasympathetic nervous activity as indicated by heart rate variability
3) Heart rate
Key secondary outcomes 1) Profile of Mood State (POMS2 short form)
2) Modified semantic differential method
3) Kwansei Gakuin (KG) daily life questionnaire
4) Trait Anxiety of State-Trait Anxiety Inventory

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Taste stimulation by a small amount (about 3 g) of chuck short ribs (90 s after chewing and swallowing) -> Rest time -> Control: Taste stimulation with the same amount of soybean substitute meat (90 s after chewing and swallowing)
Interventions/Control_2 Control: Taste stimulation with the same amount of soybean substitute meat (90 s after chewing and swallowing) -> Rest time -> Taste stimulation by a small amount (about 3 g) of chuck short ribs (90 s after chewing and swallowing)
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
18 years-old <=
Age-upper limit
30 years-old >
Gender Female
Key inclusion criteria Healthy person
Key exclusion criteria 1) Subjects who are in a poor physical condition
2) Subjects who have a respiratory illness
3) Subjects deemed inappropriate to participate in this study by the principal investigator
4) Subjects with food allergies
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Harumi
Middle name
Last name Ikei
Organization Chiba University
Division name Center for Environment, Health and Field Sciences
Zip code 277-0882
Address 6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
TEL 04-7137-8184
Email hikei@chiba-u.jp

Public contact
Name of contact person
1st name Harumi
Middle name
Last name Ikei
Organization Chiba University
Division name Center for Environment, Health and Field Sciences
Zip code 277-0882
Address 6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
TEL 04-7137-8184
Homepage URL http://www.fc.chiba-u.jp/research/naturetherapy/
Email hikei@chiba-u.jp

Sponsor
Institute Center for Environment, Health and Field Sciences, Chiba University
Institute
Department

Funding Source
Organization Himeji University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The Ethics Committees of the Center for Environment, Health and Field Sciences, Chiba University
Address 6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
Tel 04-7137-8010
Email field-rinri@chiba-u.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

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 07 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 Open public recruiting
Date of protocol fixation
2021 Year 11 Month 15 Day
Date of IRB
2021 Year 12 Month 20 Day
Anticipated trial start date
2021 Year 12 Month 20 Day
Last follow-up date
2022 Year 02 Month 22 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 01 Month 07 Day
Last modified on
2022 Year 01 Month 07 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053137

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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