UMIN-CTR Clinical Trial

Public title

Study for inhibitory effect on increase in postprandial blood glucose level by ingestion of dry sprout

Acronym

Study for inhibitory effect on increase in postprandial blood glucose level by ingestion of sprout

Scientific Title

Study for inhibitory effect on increase in postprandial blood glucose level by ingestion of dry sprout

Scientific Title:Acronym

Study for inhibitory effect on increase in postprandial blood glucose level by ingestion of sprout

Region

Japan

Condition

Healthy Adults

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify inhibitory effect on increase in postprandial blood glucose level by ingesting dry sprout.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Time course of blood glucose concentration changes before and after ingesting of dry sprout or test food(C, Cmax, Tmax, deltaAUC)

*Measure at before ingestion and 30, 60, 90, and 120 minutes after ingestion.

Key secondary outcomes

Time course of blood insulin concentration changes before and after ingesting of dry sprout and test food(C, Cmax, Tmax, deltaAUC)
*Measure at just before ingestion and 30, 60, 90, and 120 minutes after ingestion.
Blood penicidine concentration
Physical examination (body weight, blood pressure, pulse rate, BMI)
Questionnaire for subject background, excise and meal at the previous day, and physical condition and meal at the test day.

Study type

Interventional

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

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Subjects ingest any one of A to C test food once a day. After about one week washout, subjects ingest another test food once a day. After a further week washout, subjects ingest the other test food once a day.

Test food A : Dry sprout 4.3 g, Rice 150 g, Retort curry 180 g
Test food B : Control dry sprout 4.3 g, Rice 150 g, Retort curry 180 g
Test food C : Rice 150 g, Retort curry 180 g

Test food A > (about one week) > Test food B > (about one week) > Test food C

Interventions/Control_2

Test food B > (about one week) > Test food C > (about one week) > Test food A

Interventions/Control_3

Test food C > (about one week) > Test food A > (about one week) > Test food B

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Female

Key inclusion criteria

1. Healthy Japanese women over 20 years old and under 65 at the time of consent acquisition
2. Those whose BMI less than 25 at the time of screening
3. Those whose blood glucose concentration is less than 126 mg/dL at the time of screening
4. Those whose blood HbA1c is less than 6.5% at the time of screening
5. Those who apply to 4 and are top 30 of numerical value of HbA1c.

Key exclusion criteria

1. Those who have a chronic disease and are undergoing medication, those with a serious disease history
2. Those who are allergic to the test food
3. Those who regularly use medicines, specific insurance foods, health foods, etc. that may affect blood glucose levels
4. Those who have participated in other tests within the first month before the start of the exam, or who are planning to participate in other exams after this exam consent
5. Those who are judged ineligible at the discretion of the examining supervisor and research leader
6. Those who are breast-feeding, pregnant, and are planning or hoping pregnancy during the exam

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Takamasa Masuda

Organization

Healthcare Systems Co., Ltd.

Division name

Research and Development Department

Zip code

Address

Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN

TEL

03-6809-2722

Email

masudat@hc-sys.jp

Name of contact person

1st name
Middle name
Last name	Takamasa Masuda

Organization

Healthcare Systems Co., Ltd.

Division name

Research and Development Department

Zip code

Address

Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN

TEL

03-6809-2722

Homepage URL

Email

masudat@hc-sys.jp

Institute

Healthcare Systems Co., Ltd.

Institute

Department

Personal name

Organization

Saladcosmo Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

12

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2018

Year

12

Month

26

Day

Date of IRB

2018

Year

12

Month

26

Day

Anticipated trial start date

2018

Year

12

Month

26

Day

Last follow-up date

2019

Year

02

Month

09

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

12

Month

26

Day

Last modified on

2019

Year

03

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040302