UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025250
Receipt number 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 16:13:32

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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 or person

Institute

Teikyo University

Institute

Department

Personal name



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

Value
https://center6.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