UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the effect of decreasing postprandial glucose levels of functional food
Title of the study (Brief title)	A study to evaluate the effect of decreasing postprandial glucose levels of functional food
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of food on blood glucose increase.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Efficacy : Area under the curve of delta blood glucose level. Safety : Incidence of adverse events
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Subjects will take the test food once a day. After more than 1 day of washout period, subjects will take the placebo food once a day.
Interventions/Control_2	Subjects will take the placebo food once a day. After more than 1 day of washout period, subjects will take the test food once a day.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Males and females over 20 years old 2. Understanding the study and submitting the written informed consent before the study
Key exclusion criteria	1. Systolic pressure <90 mmHg 2. Subjects who are pregnant or lactating. 3. Subjects who donated over 200ml blood components or whole blood within 4 weeks 4. Male Subjects who donated over 400ml whole blood within 12 weeks 5. Female who donated over 400ml whole blood within 16 weeks 6. Male subjects whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added. 7. Female subjects whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added. 8. Subjects who are participating in other clinical studies, or who finished clinical study within 4 weeks. 9. a) Subjects with disease on heart, liver, kidney or other organs complication. b) Subjects with a previous history of disease on circulatory organs c) Subjects who are contracting diabetes. d) Subjects with test food allergy 10. Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size	20

Research contact person
Name of lead principal investigator	Yuji Nonaka
Organization	Suntory Global Innovation Center Ltd.
Division name	Research Institute
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL	050-3182-0587
Email	Yuji_Nonaka@suntory.co.jp

Public contact
Name of contact person	Keisuke Yasumoto
Organization	Suntory Global Innovation Center Ltd.
Division name	Research Institute
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL	050-3182-0496
Homepage URL
Email	Keisuke_Yasumoto@suntory.co.jp

Sponsor
Institute	Suntory Global Innovation Center Ltd.
Institute
Department

Funding Source
Organization	Suntory Global Innovation Center Ltd.
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 16 Day
Anticipated trial start date	2018 Year 01 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2018 Year 01 Month 17 Day
Last modified on	2018 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035218