UMIN-ICDS Clinical Trial

Public title

Verification study of blood glucose level fluctuation by consumption of rice cooked in a carbohydrate-cut rice cooker
-A randomized, double-blind, crossover study-

Acronym

Verification study of blood glucose level fluctuation by consumption of rice cooked in a carbohydrate-cut rice cooker
-A randomized, double-blind, crossover study-

Scientific Title

Verification study of blood glucose level fluctuation by consumption of rice cooked in a carbohydrate-cut rice cooker
-A randomized, double-blind, crossover study-

Scientific Title:Acronym

Verification study of blood glucose level fluctuation by consumption of rice cooked in a carbohydrate-cut rice cooker
-A randomized, double-blind, crossover study-

Region

Japan

Condition

Healthy subjects

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to verify blood glucose level fluctuations after a single intake of rice cooked in a carbohydrate-cut rice cooker in Japanese males and females between the ages of 20 and 65.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The incremental area under the curve of the postprandial blood glucose

Key secondary outcomes

"The incremental area under the curve of postprandial blood insulin and triglyceride levels
Cmax,delta Cmax, and Tmax of blood glucose, insulin, and triglyceride levels
Postprandial questionnaire"

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

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Single intake of white rice with 50% less sugar

Interventions/Control_2

Single intake of regular white rice

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

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Japanese male and female subjects between the ages of 20 and 65 at the time of written consent.
2. Subjects whose fasted blood glucose levels are 100 mg/dL or more and less than 126 mg/dL or 2-hour glucose value in a 75 g oral glucose tolerance test are 140 mg/dL to 200 mg/dL at the screening period.
3. Subjects who have received a full explanation of the purpose and content of the study, have the ability to consent, understand the study well, and have volunteered to participate in the study and have agreed to participate in the study in writing.

Key exclusion criteria

1. Subjects who have been diagnosed with diabetes by a physician.
2. Subjects who are currently receiving medication or outpatient treatment for some serious disease.
3. Subjects who are currently undergoing exercise or diet therapy under the supervision of a physician.
4. Subjects who may develop allergies to the test food.
5. Subjects who have a current or a history of drug dependence or alcohol dependence.
6. Subjects who are hospitalized for mental disorders (depression, etc.) or sleep disorders(insomnia, sleep apnea, etc.), or have a history of mental disorders in the past.
7. Subjects who are with extremely irregular eating, sleeping, or other habits.
8. Subjects who have an extremely unbalanced diet.
9. Subjects who have or have had serious diseases such as brain diseases, malignant tumors, immune diseases, diabetes, liver diseases (hepatitis), kidney diseases, heart diseases, etc., thyroid diseases, adrenal diseases, and other metabolic diseases.
10. Subject who use health foods and medicines that contain ingredients that affect blood glucose levels.
11. Subjects who have participated in other clinical trials (research) within 3 months retrospectively from the date of obtaining consent, or those who have plans to participate in other clinical trials (research) during the study period
12. Subjects who have collected more than 200 mL of blood within 1 month or 400 mL within 3 months prior to the date of obtaining consent.
13. Subjects who are currently pregnant or breastfeeding. or who are likely to become so during the study period.
14. Subjects who have difficulty in complying with the recording of various questionnaires.
15. Subjects who are judged to be inappropriate as subjects based on clinical laboratory test values and measured values at the time of SCR.
16. Other subjects who are judged unsuitable as subjects by the principal investigator.

Target sample size

24

Name of lead principal investigator

1st name	Yoshio
Middle name
Last name	Shishinai

Organization

forty-four Inc.

Division name

CEO

Zip code

154-0001

Address

MKK Daikanyama 5F, 2-13-1 Ebisunishi, Shibuya-ku, Tokyo, Japan

TEL

03-6805-4744

Email

yoshio.shishinai@forty-four.jp

Name of contact person

1st name	Akihiro
Middle name
Last name	Fujimoto

Organization

Medical Corporation Kyoso-kai AMC Nishi-Umeda Clinic

Division name

Department of Clinical Research Center

Zip code

530-0001

Address

Maruit Nishi-Umeda Building 3F, 3-3-45 Umeda, Kita-ku, Osaka-shi, Osaka, Japan

TEL

06-4797-5660

Homepage URL

Email

fujimoto@amc-clinic.jp

Institute

Others

Institute

Department

Personal name

Organization

Others

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

NISHI-UMEDA Clinic for Asian Medical Collaboration Ethics Review Committee

Address

Maruit Nishi-Umeda Building 3F, 3-3-45 Umeda, Kita-ku, Osaka-shi, Osaka, Japan

Tel

06-4797-5660

Email

morikawa@amc-clinic.jp

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

2023

Year

01

Month

10

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

2022

Year

11

Month

30

Day

Date of IRB

2022

Year

12

Month

15

Day

Anticipated trial start date

2023

Year

01

Month

11

Day

Last follow-up date

2023

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

01

Month

10

Day

Last modified on

2023

Year

07

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056946