UMIN-CTR Clinical Trial

Public title

An investigation study of the glycemic index (GI)

Acronym

An investigation study of the glycemic index (GI)

Scientific Title

An investigation study of the glycemic index (GI): an open-label trial

Scientific Title:Acronym

An investigation study of the glycemic index (GI)

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To measure the glycemic index (GI) of the test food

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

GI

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Duration: Single dose
Test food 1 [glucose loading]: OIKOS fat-free yogurt (plain/sweetened)
Test food 2 [glucose loading]: OIKOS fat-free yogurt (strawberry)
Test food 3 [glucose loading]: OIKOS fat-free yogurt (blueberry)
Reference food [glucose loading]: Trelan-G 50 g
Administration:
<Test food 1> Take four cups of test food 1 within 15 minutes after the fingertip micro blood sampling before glucose loading.
<Test food 2> Take four cups of test food 2 within 15 minutes after the fingertip micro blood sampling before glucose loading.
<Test food 3> Take four cups of test food 3 within 15 minutes after the fingertip micro blood sampling before glucose loading.
<Reference food> Take reference food within 15 minutes after the fingertip micro blood sampling before glucose loading.
* The intervention sequence is reference food (before consumption and test 1; Scr), reference food (test 2), test food 1 (test 3), test food 2 (test 4), to test food 3 (test 5) and each food is single ingestion.

Interventions/Control_2

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

50

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Subjects aged 20 or more and less than 50

4. Healthy subjects

5. Subjects whose body mass index (BMI) are 30 kg/m² or less at Scr

6. Subjects who are judged as eligible to participate in the study by the physician

7. Subjects whose maximum concentration (C_max) of postprandial blood glucose are 199 mg/dL or less at Scr

8. Subjects whose time to maximum concentration (T_max) of postprandial blood glucose are 30, 45, or 60 minites at Scr

9. Subjects whose incremental area under the curve (IAUC) of postprandial blood glucose are relatively high at Scr

Key exclusion criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Subjects who currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases

4. Subjects who have food allergies and/or food intolerances. Particularly, subjects who have lactose intolerance.

5. Subjects who have abnormal glucose tolerance

6. Subjects who take medications known to affect glucose tolerance

7. Subjects who have taken insulin therapy or antihyperglycemic medication for the treatment of diabetes.

8. Subjects who have been hospitalized for treatment or surgery within the last three months

9. Subjects who plan to have surgery within two weeks after this trial

10. Subjects who have or are undergoing medical treatment for diseases which influence digestion and absorption of nutrients

11. Subjects who are taking steroids, protease inhibitors, or antipsychotics

12. Subjects who use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily

13. Subjects currently taking medicines (include herbal medicines) and supplements

14. Subjects who are allergic to medications and/or the test-food-related products

15. Subjects who are pregnant, breast-feeding, and planning to become pregnant

16. Subjects who suffer from COVID-19

17. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

18. Subjects who are judged as ineligible to participate in the study by the physician

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

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

Danone Japan Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 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

2021

Year

11

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

11

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

2021

Year

11

Month

17

Day

Date of IRB

2021

Year

11

Month

17

Day

Anticipated trial start date

2021

Year

11

Month

24

Day

Last follow-up date

2022

Year

02

Month

12

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

11

Month

24

Day

Last modified on

2022

Year

03

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052692