UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051121 |
|---|---|
| Receipt number | R000058302 |
| Scientific Title | Sensory evaluation of sweetness for each concentration of sugar and sweetener |
| Date of disclosure of the study information | 2023/05/26 |
| Last modified on | 2024/03/28 15:07:41 |
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Basic information
Public title
Sensory evaluation of sweetness for each concentration of sugar and sweetener
Acronym
Sensory evaluation of sweetness for each concentration of sugar and sweetener
Scientific Title
Sensory evaluation of sweetness for each concentration of sugar and sweetener
Scientific Title:Acronym
Sensory evaluation of sweetness for each concentration of sugar and sweetener
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Quantification of sweetness intensity for each concentration of sugars and sweeteners
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
10 samples of each saccharide and sweetener with different concentrations are prepared. Subjects were blinded to these 10 samples, and were asked to (1) answere the order of sweetness intensity, and (2) evaluate the sweetness when the sweetness of a 5% sucrose solution was set to 100.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The subject avoids eating and drinking other than water for 2 hours before the test, rinses the oral cavity thoroughly with water before the test and before evaluating another sample, and then spit the sample into the oral cavity. Repeat this operation and answer the evaluation items for 10 concentrations of samples.
Interventions/Control_2
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Employees of Hayashibara who have been with the company for at least one year and are in good health and are between the ages of 18 and 65
2) Those who are not diabetic, pregnant or breastfeeding
Key exclusion criteria
Diabetic patient, pregnant or lactating persons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Otsuka |
Organization
Hayashibara CO., LTD.
Division name
Research and technology division, Research department
Zip code
7028006
Address
675-1, Fujisaki, Naka-ku, Okayama
TEL
0862763141
yuki.otsuka@hb.nagase.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Otsuka |
Organization
Hayashibara CO., LTD.
Division name
Research and technology division, Research department
Zip code
7028006
Address
675-1, Fujisaki, Naka-ku, Okayama
TEL
0862763141
Homepage URL
yuki.otsuka@hb.nagase.co.jp
Sponsor or person
Institute
Hayashibara CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
None
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
The Ethics Committee of Hayashibara Co., Ltd.
Address
675-1, Fujisaki, Naka-ku, Okayama
Tel
086-276-3141
HB96301@hb.nagase.co.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
| 2023 | Year | 05 | Month | 26 | 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
40
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
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 08 | 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
| 2023 | Year | 05 | Month | 22 | Day |
Last modified on
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058302
