UMIN-CTR Clinical Trial

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	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

Progress
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
Other related information

Management information
Registered date	2021 Year 11 Month 24 Day
Last modified on	2022 Year 03 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052692