UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035648
Receipt number R000040608
Scientific Title A study for an effect of the food containing plant-derived ingredient on blood glucose level(SBF-2018-05-SMLIY)
Date of disclosure of the study information 2019/01/24
Last modified on 2019/08/05 15:11:49

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Basic information

Public title

A study for an effect of the food containing plant-derived ingredient on blood glucose level(SBF-2018-05-SMLIY)

Acronym

A study for an effect of the food containing plant-derived ingredient on blood glucose level

Scientific Title

A study for an effect of the food containing plant-derived ingredient on blood glucose level(SBF-2018-05-SMLIY)

Scientific Title:Acronym

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
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

6

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Subjects will take the food (1) once a day. After more than 5 days of washout period, subjects will take the food (2) once a day. After more than 5 days of washout period, subjects will take the placebo food once a day.

Interventions/Control_2

Subjects will take the food (1) once a day. After more than 5 days of washout period, subjects will take the placebo food once a day. After more than 5 days of washout period, subjects will take the food (2) once a day.

Interventions/Control_3

Subjects will take the food (2) once a day. After more than 5 days of washout period, subjects will take the food (1) once a day. After more than 5 days of washout period, subjects will take the placebo food once a day.

Interventions/Control_4

Subjects will take the food (2) once a day. After more than 5 days of washout period, subjects will take the placebo food once a day. After more than 5 days of washout period, subjects will take the food (1) once a day.

Interventions/Control_5

Subjects will take the placebo food once a day. After more than 5 days of washout period, subjects will take the food (1) once a day. After more than 5 days of washout period, subjects will take the food (2) once a day.

Interventions/Control_6

Subjects will take the placebo food once a day. After more than 5 days of washout period, subjects will take the food (2) once a day. After more than 5 days of washout period, subjects will take the food (1) once a day.

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

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

050-3182-6114

Email

Takanori_Teramoto@suntory.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kaori Matsuoka

Organization

Suntory Beverage & Food Limited

Division name

Development and Design Department

Zip code


Address

13-2 Imaikamicho, Nakahara, Kawasaki, Kanagawa, 211-0067 Japan

TEL

050-3182-0550

Homepage URL


Email

Kaori_Matsuoka@suntory.co.jp


Sponsor or person

Institute

Suntory Beverage & Food Limited

Institute

Department

Personal name



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)



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

2019 Year 01 Month 24 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

2018 Year 11 Month 15 Day

Date of IRB

2018 Year 11 Month 15 Day

Anticipated trial start date

2019 Year 01 Month 24 Day

Last follow-up date

2019 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 01 Month 23 Day

Last modified on

2019 Year 08 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040608


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name