UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of palatinose about palatability and carbohydrate metabolism
Title of the study (Brief title)	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	Yoko Ichikawa
Organization	Graduate school of integrated pharmaceutical and nutritional sciences, University of Shizuoka
Division name	Laboratory of Food Management
Address	52-1, Yada, Suruga-ku, Shizuoka
TEL	054-264-5512
Email	ichity@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	Yoko Ichikawa
Organization	University of Shizuoka
Division name	Graduate school of integrated pharmaceutical and nutritional sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000029027