UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An exploratory study on the effect of functional food
Title of the study (Brief title)	An exploratory study on the effect 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 functional food containing beverage on blood glucose increase.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Efficacy : Area under the curve of 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	Open -no one is 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	Subjects take a bottle of placebo beverage once in a day. After 6-9 days washout, subjects take a bottle of one kind of functional food containing beverage once in a day. After 6-9 days washout, subjects take a bottle of two kinds of functional food containing beverage (low dose) once in a day. After 6-9 days washout, subjects take a bottle of two kinds of functional food containing beverage (high dose) once in a day. In each time, subjects take 75g of glucose 30mins after beverage intake.
Interventions/Control_2	Subjects take a bottle of one kind of functional food containing beverage once in a day. After 6-9 days washout, subjects take a bottle of two kinds of functional food containing beverage (low dose) once in a day. After 6-9 days washout, subjects take a bottle of two kinds of functional food containing beverage (high dose) once in a day. After 6-9 days washout, subjects take a bottle of placebo beverage once in a day. In each time, subjects take 75g of glucose 30mins after beverage intake.
Interventions/Control_3	Subjects take a bottle of two kinds of functional food containing beverage (low dose) once in a day. After 6-9 days washout, subjects take a bottle of two kinds of functional food containing beverage (high dose) once in a day. After 6-9 days washout, subjects take a bottle of placebo beverage once in a day. After 6-9 days washout, subjects take a bottle of one kind of functional food containing beverage once in a day. In each time, subjects take 75g of glucose 30mins after beverage intake.
Interventions/Control_4	Subjects take a bottle of two kinds of functional food containing beverage (high dose) once in a day. After 6-9 days washout, subjects take a bottle of placebo beverage once in a day. After 6-9 days washout, subjects take a bottle of one kind of functional food containing beverage once in a day. After 6-9 days washout, subjects take a bottle of two kinds of functional food containing beverage (low dose) once in a day. In each time, subjects take 75g of glucose 30mins after beverage intake.
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	Subjects whose past fasting blood glucose levels were between 100 mg/dL or more and less than 130 mg/dL are screened by 75 g OGTT and subjects who are diagnosed as borderline hyperglycemia or high normal blood glucose will be selected.
Key exclusion criteria	(1)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating. (2)Subjects with disease on heart, liver, kidney or other organs complication. (3)Subjects with a previous history of disease on circulatory organs (4)Subjects who have allergic reaction to drug medicine and food. (5)Subjects who drink alcohol a lot and smoke a lot. (6)Subjects who have an extremely irregular dietary habit. (7)Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results. (8)Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size	28

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

Public contact
Name of contact person	Hiroshi Watanabe
Organization	Suntory Global Innovation Center Ltd.
Division name	Research Institute
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL	050-3182-0593
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

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 25 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2017 Year 05 Month 15 Day
Date analysis concluded	2017 Year 05 Month 31 Day

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

Management information
Registered date	2017 Year 01 Month 20 Day
Last modified on	2018 Year 07 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029583