UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate the effect of decreasing postprandial glucose levels of the botanical extract.
Acronym	A study to evaluate the effect of decreasing postprandial glucose levels of the botanical extract.
Scientific Title	A study to evaluate the effect of decreasing postprandial glucose levels of the botanical extract.
Scientific Title:Acronym	A study to evaluate the effect of decreasing postprandial glucose levels of the botanical extract.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of the beverage containing botanical extract on postprandial glucose levels.
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	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Subjects will take the food containing botanical extract (1) once a day. After more than 5 days of washout period, subjects will take the beverage containing botanical extract (2) once a day. After more than 5 days of washout period, subjects will take the placebo beverage once a day.
Interventions/Control_2	Subjects will take the beverage containing botanical extract (2) once a day. After more than 5 days of washout period, subjects will take the placebo beverage once a day. After more than 5 days of washout period, subjects will take the beverage containing botanical extract (1) once a day.
Interventions/Control_3	Subjects will take the placebo beverage once a day. After more than 5 days of washout period, subjects will take the beverage containing botanical extract (1) once a day. After more than 5 days of washout period, subjects will take the beverage containing botanical extract (2) once a day.
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. Males and females from 20 to 64 years of age 2. Understanding the study and submitting the written informed consent before the study
Key exclusion criteria	1. Females in pregnancy, lactation and scheduled pregnancy period. 2. Subjects who are attending other studies or attended other studies within past 4 weeks. 3. With present heart disorder, liver disorder, or kidney disorder 4. With previous or present cardiac disorder 5. With diabetes mellitus 6. Subjects who are deemed to be unsuitable by the investigator.
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Takanori Teramoto
Organization	Suntory Beverage & Food Limited
Division name	Development and Design Department
Zip code
Address	13-2 Imaikamicho, Nakahara, Kawasaki, Kanagawa, 211-0067 Japan
TEL	044-738-5365
Email	Takanori_Teramoto@suntory.co.jp

Public contact
1st name of contact person	1st name Middle name Last name Tadashi Furumoto
Organization	Suntory Beverage & Food Limited
Division name	Development and Design Department
Zip code
Address	13-2 Imaikamicho, Nakahara, Kawasaki, Kanagawa, 211-0067 Japan
TEL	044-738-5246
Homepage URL
Email	Tadashi_Furumoto@suntory.co.jp

Sponsor
Institute	Suntory Beverage & Food Limited
Institute
Department

Funding Source
Organization	Suntory Beverage & Food Limited
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 09 Month 22 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 21 Day
Date of IRB	2017 Year 09 Month 21 Day
Anticipated trial start date	2017 Year 09 Month 23 Day
Last follow-up date	2017 Year 12 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 09 Month 22 Day
Last modified on	2019 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033420