UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on the effect of functional food containing beverage on blood glucose level in human.
Title of the study (Brief title)	A study on the effect of functional food containing beverage on blood glucose level in human.
Region	Japan

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

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

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

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Subjects take a can of two kinds of functional foods containing beverage once in a day. After 6-days washout, subjects take a can of placebo beverage once in a day. After 6-days washout, subjects take a can of one kind of functional food containing beverage once in a day. In each time, subjects take 300g of rice 30mins after beverage intake.
Interventions/Control_2	Subjects take a can of one kind of functional food containing beverage once in a day. After 6-days washout, subjects take a can of two kinds of functional foods containing beverage once in a day. After 6-days washout, subjects take a can of placebo beverage once in a day. In each time, subjects take 300g of rice 30mins after beverage intake.
Interventions/Control_3	Subjects take a can of placebo beverage once in a day. After 6-days washout, subjects take a can of one kind of functional food containing beverage once in a day. After 6-days washout, subjects take a can of two kinds of functional foods containing beverage once in a day. In each time, subjects take 300g of rice 30mins after beverage intake.
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1)Healthy males aged 20 or more and less than 65 years-old. 2)Subjects with fasting blood glucose level 100 mg/dL or more and less than 126 mg/dL 3)Subjects who can visit hospital on designated day. 4)Subjects giving written informed consent.
Key exclusion criteria	1)Subjects with constant drug treatment. 2)Subjects who are contracting diabetes. 3)Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results. 4)Subjects with a previous history of disease on heart, liver, kidney or digestive organs. 5)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating. 6)Subjects who drink alcohol a lot and smoke a lot. 7)Subjects who have an irregular sleep cycle, work shift or work on midnight shift. 8)Subjects who have allergic reaction to drug medicine and food. 9)Subjects whose systolic blood pressure is less than 90mmHg. 10)Subjects who donated 200 mL of blood and/or blood components within four weeks prior to the current study. 11)Male subjects whose blood was collected more than 400 mL within the last twelve weeks. 12)Female subjects whose blood was collected more than 400 mL within the last sixteen weeks. 13)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. 14)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. 15)Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks. 16)Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size	21

Research contact person
Name of lead principal investigator	Norihito Murayama
Organization	Suntory Global Innovation Center Ltd.
Division name	Innovation Development Department
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL	050-3182-0588
Email	Norihito_Murayama@suntory.co.jp

Public contact
Name of contact person	Hiroshi Watanabe
Organization	Suntory Global Innovation Center Ltd.
Division name	Innovation Development Department
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL	050-3182-0593
Homepage URL
Email	H_Watanabe@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	医療法人社団慈昂会　福住内科クリニック　（北海道）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 16 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 10 Month 14 Day
Anticipated trial start date	2016 Year 10 Month 17 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	2016 Year 10 Month 11 Day
Last modified on	2016 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027732