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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029239
Receipt No. R000033420
Scientific Title A study to evaluate the effect of decreasing postprandial glucose levels of the botanical extract.
Date of disclosure of the study information 2017/09/22
Last modified on 2019/05/08

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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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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