UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046166
Receipt No. R000052692
Scientific Title An investigation study of the glycemic index (GI): an open-label trial
Date of disclosure of the study information 2021/11/24
Last modified on 2021/11/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
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
Condition Healthy Japanese subjects
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes GI
Key secondary outcomes

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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 (Cmax) of postprandial blood glucose are 199 mg/dL or less at Scr

8. Subjects whose time to maximum concentration (Tmax) 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

Research contact person
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

Public contact
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

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization Danone Japan Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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)

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 24 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 Open public recruiting
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
Other related information

Management information
Registered date
2021 Year 11 Month 24 Day
Last modified on
2021 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052692

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.