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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035280
Receipt No. R000040195
Scientific Title Validation of preferred salt concentration as soup in young adults
Date of disclosure of the study information 2018/12/24
Last modified on 2019/06/17

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Basic information
Public title Validation of preferred salt concentration as soup in young adults
Acronym Validation of preferred salt concentration as soup in young adults
Scientific Title Validation of preferred salt concentration as soup in young adults
Scientific Title:Acronym Validation of preferred salt concentration as soup in young adults
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 influence of Umami on the salty tast 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

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 Male and Female
Key inclusion criteria Adult men and women who agreed to participate in this research with written informed consent.
Key exclusion criteria (1) Persons with eating disorders.
(2) Persons with taste disorders.
(3) Persons who has eaten within 2 hours.
(4) Persons who judged that a principal investigator is inappropriate for participating in the examination.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Hitomi
Middle name
Last name Hayabuchi
Organization Fukuoka Women's University
Division name Department of Food and Health Sciences, International College of Arts and Sciences
Zip code 813-8529
Address 1-1-1 Kasumigaoka, Higashiku, Fukuoka, Japan
TEL 092-661-2411
Email s-hayabuchi@fwu.ac.jp

Public contact
Name of contact person
1st name Kiyoshi
Middle name
Last name Koga
Organization Fukuoka Women's University
Division name Department of Food and Health Sciences, International College of Arts and Sciences
Zip code 813-8529
Address 1-1-1 Kasumigaoka, Higashiku, Fukuoka, Japan
TEL 092-661-2411
Homepage URL
Email keiei@fwu.ac.jp

Sponsor
Institute Fukuoka Women's University
Institute
Department

Funding Source
Organization Fukuoka Women's University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Ajinomoto co., Inc
Name of secondary funder(s) Ajinomoto co., Inc

IRB Contact (For public release)
Organization Research Ethics Review Committee at Fukuoka Women's University
Address 1-1-1 Kasumigaoka, Higashiku, Fukuoka, Japan
Tel 092-661-2411
Email keiei@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(福岡県)、青森県立保健大学(青森県)、千葉県立保健医療大学(千葉県)、相模女子大学(神奈川県)、静岡県立大学(静岡県)、安田女子大学(広島県)、鹿児島純心女子大学(鹿児島県)、奈良女子大学(奈良県)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 24 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
2017 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 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
2018 Year 12 Month 17 Day
Last modified on
2019 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040195

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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