UMIN-CTR Clinical Trial

Basic information
Public title	Validation of umami effect for female students from Asia.
Acronym	Validation of umami effect for female students from Asia.
Scientific Title	Validation of umami effect for female students from Asia.
Scientific Title:Acronym	Validation of umami effect for female students from Asia.
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to verify the effect of umami on the salty test or palatability of low salt solution.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Taste (salty taste, palatability)
Key secondary outcomes	Differences in taste (saltiness, desirability) due to country of origin, saltiness preferences, and physical activity.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	6
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	0.3% NaCl aqueous solution (w/v)
Interventions/Control_2	0.3% NaCl + 0.3% glutamate Na aqueous solution (w/v)
Interventions/Control_3	0.6% NaCl aqueous solution (w/v)
Interventions/Control_4	0.6% NaCl + 0.3% glutamate Na aqueous solution (w/v)
Interventions/Control_5	0.9% NaCl aqueous solution (w/v)
Interventions/Control_6	0.9% NaCl + 0.3% glutamate Na aqueous solution (w/v)
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	Adult women students from Asia who agreed to participate in this research with written informed consent.
Key exclusion criteria	(1) Persons with eating disorders. (2) Persons whit taste disorders. (3) Persons who have eaten within 2 hours. (4) Persons who judged that a principal investigator is inappropriate for participation in the examination.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masanori Middle name Last name Ohta
Organization	Fukuoka Women's University
Division name	Department of Food and Health Sciences, Institutional College of Arts andSciences
Zip code	813-8529
Address	1-1-1 Kasumigaoka, Higashi-ku, Fukuoka, Japan
TEL	092-991-2411
Email	m-ohta@fwu.ac.jp

Public contact
Name of contact person	1st name Rieko Middle name Last name Morita
Organization	Fukuoka Women's University
Division name	Department of Food and Health Sciences, Institutional College of Arts andSciences
Zip code	813-8529
Address	1-1-1 Kasumigaoka, Higashi-ku, Fukuoka, Japan
TEL	092-991-2411
Homepage URL
Email	r.morita@fwu.ac.jp

Sponsor
Institute	Fukuoka Women's University
Institute
Department

Funding Source
Organization	Society for Research on Umami Taste
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Research Ethics Review Committee at Fukuoka Women's University
Address	1-1-1 Kasumigaoka, Higashi-ku, Fukuoka, Japan
Tel	092-661-2411
Email	soumu@fwu.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	福岡女子大学

Other administrative information
Date of disclosure of the study information	2021 Year 10 Month 27 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	Enrolling by invitation
Date of protocol fixation	2021 Year 09 Month 16 Day
Date of IRB	2021 Year 09 Month 24 Day
Anticipated trial start date	2021 Year 10 Month 23 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 10 Month 26 Day
Last modified on	2021 Year 10 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052362