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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034752
Receipt No. R000039626
Official scientific title of the study A study for an effect of the food containing plant-derived ingredient on blood glucose level(SBF-2018-06-MMLIY)
Date of disclosure of the study information 2018/11/05
Last modified on 2018/11/02

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Basic information
Official scientific title of the study A study for an effect of the food containing plant-derived ingredient on blood glucose level(SBF-2018-06-MMLIY)
Title of the study (Brief title) A study for an effect of the food containing plant-derived ingredient on blood glucose level
Region
Japan

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

Objectives
Narrative objectives1 To evaluate an effect of the food containing plant-derived ingredient on blood glucose level
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, fasting blood glucose, HbA1c, HOMA-IR
Safety : Incidence of adverse effects
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
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 Functional food(low dose), 12 weeks
Interventions/Control_2 Functional food(high dose), 12 weeks
Interventions/Control_3 Food without functional food, 12 weeks
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 male and female whose age are 20 <= years old <65.
(2)Subjects who are able to submit the written informed consents.
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, or
(6)Subjects who are deemed to be unsuitable by the investigator.
Target sample size 60

Research contact person
Name of lead principal investigator Takanori Teramoto
Organization Suntory Beverage & Food Limited
Division name Development and Design Department
Address 13-2 Imaikamicho, Nakahara, Kawasaki, Kanagawa, 211-0067 Japan
TEL 050-3182-6114
Email Takanori_Teramoto@suntory.co.jp

Public contact
Name of contact person Hiroyuki Kato
Organization Suntory Beverage & Food Limited
Division name Development and Design Department
Address 13-2 Imaikamicho, Nakahara, Kawasaki, Kanagawa, 211-0067 Japan
TEL 050-3182-6114
Homepage URL
Email Hiroyuki_Kato@suntory.co.jp

Sponsor
Institute Suntory Beverage & Food Limited
Institute
Department

Funding Source
Organization Suntory Beverage & Food Limited
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 11 Month 05 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 01 Day
Anticipated trial start date
2018 Year 11 Month 05 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 11 Month 02 Day
Last modified on
2018 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039626

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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