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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025239
Receipt No. R000029027
Scientific Title Investigation of palatinose about palatability and carbohydrate metabolism
Date of disclosure of the study information 2016/12/13
Last modified on 2017/06/15

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Basic information
Public title Investigation of palatinose about palatability and carbohydrate metabolism
Acronym Investigation of palatinose about palatability and carbohydrate metabolism
Scientific Title Investigation of palatinose about palatability and carbohydrate metabolism
Scientific Title:Acronym Investigation of palatinose about palatability and carbohydrate metabolism
Region
Japan

Condition
Condition Healthy adult male and female
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the changes of postprandial carbohydrate metabolism in healthy people after consuming the meals used sucrose or double amount of palatinose.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes blood glucose
Key secondary outcomes serum insulin, GIP, GLP-1

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 consuming the meals used double amount of palatinose
Interventions/Control_2 consuming the meals used sucrose
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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria Subjects who are given informed consent
Key exclusion criteria medicated person (like antihypertensive drug)

glucose intolerance

during mensturation
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoko Ichikawa
Organization Graduate school of integrated pharmaceutical and nutritional sciences, University of Shizuoka
Division name Laboratory of Food Management
Zip code
Address 52-1, Yada, Suruga-ku, Shizuoka
TEL 054-264-5512
Email ichity@u-shizuoka-ken.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoko Ichikawa
Organization University of Shizuoka
Division name Graduate school of integrated pharmaceutical and nutritional sciences
Zip code
Address 52-1, Yada, Suruga-ku, Shizuoka
TEL 054-264-5512
Homepage URL
Email ichity@u-shizuoka-ken.ac.jp

Sponsor
Institute University of Shizuoka
Institute
Department

Funding Source
Organization Mitsui Sugar Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 13 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 Completed
Date of protocol fixation
2016 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 07 Day
Last follow-up date
2017 Year 04 Month 30 Day
Date of closure to data entry
2017 Year 05 Month 31 Day
Date trial data considered complete
Date analysis concluded
2017 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 12 Month 12 Day
Last modified on
2017 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029027

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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