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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025250
Receipt No. R000029048
Scientific Title Difference in the degree of sweetness by conversion of glucose to fructose ratio
Date of disclosure of the study information 2016/12/19
Last modified on 2016/12/13

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Basic information
Public title Difference in the degree of sweetness by conversion of glucose to fructose ratio
Acronym Difference in the degree of sweetness by conversion of glucose to fructose ratio
Scientific Title Difference in the degree of sweetness by conversion of glucose to fructose ratio
Scientific Title:Acronym Difference in the degree of sweetness by conversion of glucose to fructose ratio
Region
Japan

Condition
Condition adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 9 kinds of glucose fructose mixed test solution (hereinafter referred to as mixed sugar solution) were prepared by changing the ratio of glucose and fructose. Mixed sugar solution is licked by a person, mixed sugar solution mixed with same amount of glucose and fructose as reference (0), data of sweetness evaluation is taken and analyzed in 6 steps. By doing this, we aim to search for the proportion of mixed sugar solution with the least sweetness and less variability from human.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Nine mixed sugar solutions with different ratios of glucose (Gul) and fructose (Ful) are prepared. Gul 4 g Ful 4 g as reference mixed sugar solution, and its sweetness is set to 0. Have the subject blindly observe the nine kinds of mixed sugar solutions and let them be licked, evaluate the sweetness of the test medicine in six stages from 3 to -3 with the standard mixed Glu 4 g Ful 4 g mixed sugar solution set to 0.
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
Other
Interventions/Control_1 Subjects should avoid eating and drinking 30 minutes before the test, rinse the oral cavity well with water before the test, spit the sample in the oral cavity for 10 seconds, then vomit and exhale to the evaluation items. Also, after a while, review again and verify reproducibility.
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 adult
Key exclusion criteria Diabetic patient
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Moemi Saito
Organization Teikyo University
Division name Faculty of pharmaceutical Sciences
Zip code
Address 2-11-1,Kaga,Itabashi,Tokyo
TEL 03-3964-8436
Email smoemi@med.teikyo-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Moemi Saito
Organization Teikyo University
Division name Faculty of pharmaceutical Sciences
Zip code
Address 2-11-1,Kaga,Itabashi,Tokyo
TEL 03-3964-8436
Homepage URL
Email smoemi@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University
Institute
Department

Funding Source
Organization Teikyo University
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
Address
Tel
Email

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
2016 Year 12 Month 19 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
Date of protocol fixation
2016 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 19 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
2016 Year 12 Month 13 Day
Last modified on
2016 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029048

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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