UMIN-CTR Clinical Trial

Public title

A verification study of the effects of test food consumption on postprandial blood glucose levels in healthy Japanese

Acronym

A verification study of the effects of test food consumption on postprandial blood glucose levels in healthy Japanese

Scientific Title

A verification study of the effects of test food consumption on postprandial blood glucose levels in healthy Japanese: a randomized, placebo-controlled, double-blind, crossover comparison study

Scientific Title:Acronym

A verification study of the effects of test food consumption on postprandial blood glucose levels in healthy Japanese

Region

Japan

Condition

Healthy Japanese

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of test food consumption on postprandial blood glucose levels in healthy Japanese

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. Measured value of the incremental area under the curve (IAUC) of blood glucose (GLU)

Key secondary outcomes

1. Maximum blood concentration (Cmax) and delta-Cmax of GLU, and measured values of GLU at each assessment point (before test food consumption, and 30, 60, 90, and 120 minutes after the load)

2. Individuals who experienced adverse events

3. Systolic and diastolic blood pressure in Test 1 and Test 2

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

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

<Duration>
Single ingestion
<Test products>
Test 1: Food containing rice bran extract
Test 2: Food not containing rice bran extract
Load food: Bread (Pasco Shikishima Corporation), strawberry jam (Sudo Jam Co., Ltd.)
<Administration>
Test 1: Consume 10 capsules with water 30 minutes before the load food consumption.
Test 2: Consume 10 capsules with water 30 minutes before the load food consumption.
Load food: At screening, after the completion of the pre-consumption test, and at the main test, 30 minutes after the test product consumption, consume 1 slice of bread (4-sliced) and 20 g of strawberry jam over 5 minutes.

*The daily dose should be consumed within the same day and should not be carried over to the following day.
* Test 1 followed by Test 2.
* The washout period is 1 week or more.

Interventions/Control_2

<Duration>
Single ingestion
<Test products>
Test 1: Food not containing rice bran extract
Test 2: Food containing rice bran extract
Load food: Bread (Pasco Shikishima Corporation), strawberry jam (Sudo Jam Co., Ltd.)
<Administration>
Test 1: Consume 10 capsules with water 30 minutes before the load food consumption.
Test 2: Consume 10 capsules with water 30 minutes before the load food consumption.
Load food: At screening, after the completion of the pre-consumption test, and at the main test, 30 minutes after the test product consumption, consume 1 slice of bread (4-sliced) and 20 g of strawberry jam over 5 minutes.

*The daily dose should be consumed within the same day and should not be carried over to the following day.
* Test 1 followed by Test 2.
* The washout period is 1 week or more.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Adults

4. Healthy individuals

5. Individuals whose blood glucose level is relatively high

6. Individuals whose IAUC of GLU is relatively large at screening

7. Individuals whose BMI is relatively high

Key exclusion criteria

1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction

2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator

3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims

5. Individuals who are taking or using medications (including herbal medicines) or supplements

6. Individuals who are allergic to medications or foods related to the test product (particularly, rice, wheat, milk ingredients, or pork)

7. Individuals who are smokers or have not yet completed one year since quitting smoking

8. Individuals who are pregnant, lactating, or planning pregnancy during this study

9. Individuals who are deemed unsuitable for participation in this study by the principal investigator

Target sample size

10

Name of lead principal investigator

1st name	Tsuyoshi
Middle name
Last name	Takara

Organization

Medical Corporation Seishinkai, Takara Clinic

Division name

Director

Zip code

141-0022

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

TEL

03-5793-3623

Email

t-takara@takara-clinic.com

Name of contact person

1st name	Naoko
Middle name
Last name	Suzuki

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

Tsuno Rice Fine Chemicals Co., Ltd

Institute

Department

Personal name

Organization

Tsuno Rice Fine Chemicals Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

Tel

03-5793-3623

Email

IRB@takara-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Date of disclosure of the study information

2026

Year

08

Month

04

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

Open public recruiting

Date of protocol fixation

2026

Year

07

Month

21

Day

Date of IRB

2026

Year

07

Month

21

Day

Anticipated trial start date

2026

Year

08

Month

04

Day

Last follow-up date

2026

Year

09

Month

25

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

08

Month

04

Day

Last modified on

2026

Year

08

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071497