UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of palatinose blended sweets on blood glucose levels
Title of the study (Brief title)	The effect of palatinose blended sweets on blood glucose levels
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of blood glucose inhibitory effect of ingested of sweets containing palatinose.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison between groups on blood glucose levels before meals and 15, 30, 60, 90, and 120 minutes after a meal.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	test DORAYAKI containing palatinose
Interventions/Control_2	placebo DORAYAKI without palatinose
Interventions/Control_3	test DAIHUKU containing palatinose
Interventions/Control_4	placebo DAIHUKU without palatinose
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy subject
Key exclusion criteria	1) Diabetes. 2) Subjects who are under medication or having a history of serious diseases for which medication was required. 3) Subjects who have allergy symptoms (wheat, eggs, milk, nuts). 4) Subjects who may be pregnant or possible pregnant. 5) Subjects who are lactating. 6) Subjects who are unsuitable for the entry judged by a doctor
Target sample size	30

Research contact person
Name of lead principal investigator	Haruko Takeyama
Organization	Waseda University (Graduate School)
Division name	Integrated Institute for Regulatory Science, Research Organization for Nano & Life Innovation
Address	2-2, wakamatsu-cho, Shinjyuku, Tokyo
TEL	03-5369-7326
Email	haruko-takeyama@waseda.jp

Public contact
Name of contact person	Naoko Takamizawa
Organization	Waseda University (Graduate School)
Division name	Integrated Institute for Regulatory Science, Research Organization for Nano & Life Innovation
Address	2-2, wakamatsu-cho, Shinjyuku, Tokyo
TEL	03-5369-7326
Homepage URL
Email	takamizawa.n@aoni.waseda.jp

Sponsor
Institute	Eitaro sohonpo co.
Institute
Department

Funding Source
Organization	Eitaro sohonpo co.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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	株式会社榮太樓總本鋪(東京都)

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 05 Month 01 Day
Anticipated trial start date	2018 Year 06 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 06 Day
Last modified on	2018 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034093