UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035289
Receipt No. R000040203
Scientific Title Validation of preferred salt concentration as soup aimed to improvement of food environment for health promotion
Date of disclosure of the study information 2018/12/24
Last modified on 2019/06/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Validation of preferred salt concentration as soup aimed to improvement of food environment for health promotion
Acronym Validation of preferred salt concentration as soup for health promotion
Scientific Title Validation of preferred salt concentration as soup aimed to improvement of food environment for health promotion
Scientific Title:Acronym Validation of preferred salt concentration as soup for health promotion
Region
Japan

Condition
Condition adults
Classification by specialty
Not applicable 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, and to explore the preferred salt concentration as soup which contribute to improvement of food environment for health promotion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Salty taste and palatability by sensory evaluation
Key secondary outcomes Reduction of sodium intake

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
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

Not applicable
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 cognitive impairment
(2) persons who were judged inadequate by investigator
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Hitomi
Middle name
Last name Hayabuchi
Organization Nara Women's University
Division name Faculty of human life and environment, Department of food science and nutrition
Zip code 830-8506
Address Kita-uoya Nishi-machi, Nara-city, Nara, Japan.
TEL 0742-20-3488
Email h.hayabuchi@cc.nara-wu.ac.jp

Public contact
Name of contact person
1st name Hitomi
Middle name
Last name Hayabuchi
Organization Nara Women's University
Division name Faculty of human life and environment, Department of food science and nutrition
Zip code 830-8506
Address Kita-uoya Nishi-machi, Nara-city, Nara, Japan.
TEL 0742-20-3488
Homepage URL
Email h.hayabuchi@cc.nara-wu.ac.jp

Sponsor
Institute Nara Women's University
Institute
Department

Funding Source
Organization Institute for Inovation, Ajinomoto Co., Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Research Ethics Review Committee at Nara Women's University
Address Kita-uoya Higashi-machi, Nara-city, Nara, Japan
Tel 0742-20-3762
Email kenkyou@cc.nara-wu.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 奈良女子大学(奈良県)、福岡女子大学(福岡県)、東北大学(宮城県)、琉球大学(沖縄県)、製鉄記念八幡病院(福岡県)、JA静岡厚生連遠州病院(静岡県)、日下医院(広島県)、JMA東埼玉総合病院(埼玉県)

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
2018 Year 06 Month 18 Day
Date of IRB
Anticipated trial start date
2018 Year 07 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=R000040203

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.