UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044484
Receipt number R000050743
Scientific Title A study evaluating the antihyperglycemic effect of botanical ingredient-containing food.
Date of disclosure of the study information 2021/06/18
Last modified on 2022/06/29 20:35:18

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Basic information

Public title

A study evaluating the antihyperglycemic effect of botanical ingredient-containing food.

Acronym

A study evaluating the antihyperglycemic effect of botanical ingredient-containing food.

Scientific Title

A study evaluating the antihyperglycemic effect of botanical ingredient-containing food.

Scientific Title:Acronym

A study evaluating the antihyperglycemic effect of botanical ingredient-containing food.

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective is to evaluate the effect of botanical ingredient-containing food on glucose tolerance by Oral Glucose Tolerance Test before and after repeated intake for 4 weeks.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Area under the curve of blood glucose levels after Oral Glucose Tolerance Test

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

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Subjects take control food for 4 weeks. Before and after repeated intake, subjects take Oral Glucose Tolerance Test to measure blood glucose levels.

Interventions/Control_2

Subjects take test food (containing botanical ingredient) for 4 weeks. Before and after repeated intake, subjects take Oral Glucose Tolerance Test to measure blood glucose levels.

Interventions/Control_3


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 subjects whose ages are 20 <= years old <65.
(2) Subjects who can visit the specified clinic on the scheduled day.
(3) Subjects who agree with the given description and express informed consent via telecommunication and written documents.

Key exclusion criteria

(1) Systolic pressure <90 mmHg
(2) Subjects who are pregnant or lactating.
(3) Subjects who donated over 200ml blood components or whole blood within the past 4 weeks prior to the current study.
(4) Male who donated over 400ml whole blood within the past 12 weeks.
(5) Female who donated over 400ml whole blood within the past 16 weeks.
(6) Male whose blood was collected more than 1200 mL within the last 12 months when the amount of blood sampling in the current study is added.
(7) Female whose blood was collected over 800 mL within the last 12 months when the amount of blood sampling in the current study is added.
(8) Subjects who are participating in other clinical studies, or who finished clinical study within the last 4 weeks.
(9)Subjects
a) with disease on heart, liver, kidney or other organs complications. b) with a previous history of disease on circulatory organs. c) who are contracting diabetes. d) with test food allergy.
e) whose fasting blood glucose is equivalent to or higher than 140 mg/dL by a finger stick blood test.
(10) Subjects who have severe allergic reaction to drug medicine and food.
(11) Subjects with a previous history of feeling sick after blood sampling.
(12) Subjects who have difficulty in blood sampling from peripheral vein.
(13) Subjects who drink over 60 g of alcohol per day on average.
(14) Subjects who have irregular eating patterns.
(15) Subjects who work irregular shifts or at midnight.
(16) Subjects whose BMI is less than 18.5 or over 30.0 kg/m2.
(17) Subjects who are constantly taking certain drug medicine, or who are expecting taking it within the period of current study, or who have indispensable supplements, functional foods affecting the test results.
(18) Subjects who are contracting atopic dermatitis and/or allergy symptoms.
(19) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Takanori
Middle name
Last name Teramoto

Organization

Suntory Global Innovation Center Ltd.

Division name

Research Institute

Zip code

619-0284

Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan

TEL

05031826114

Email

Takanori_Teramoto@suntory.co.jp


Public contact

Name of contact person

1st name Tomoki
Middle name
Last name Uchida

Organization

Suntory Global Innovation Center Ltd.

Division name

Research Institute

Zip code

619-0284

Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan

TEL

05031820381

Homepage URL


Email

Tomoki_Uchida@suntory.co.jp


Sponsor or person

Institute

Suntory Global Innovation Center Ltd.

Institute

Department

Personal name



Funding Source

Organization

None

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

Fukuhara Clinic Clinical Trial Review Committee

Address

3-1-15, Shimamatsuhigashi-machi, Eniwa-shi, Hokkaido, 061-1351 Japan

Tel

0123-36-8029

Email

d-kameda@mediffom.co.jp


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

2021 Year 06 Month 18 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

2021 Year 05 Month 20 Day

Date of IRB

2021 Year 05 Month 17 Day

Anticipated trial start date

2021 Year 07 Month 26 Day

Last follow-up date

2021 Year 10 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 06 Month 09 Day

Last modified on

2022 Year 06 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050743


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name