UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the effects on blood glucose level in Japanese patients with type 2 diabetes who are on diet therapy: a randomized, double-blind, crossover trial
Acronym	Evaluation of the effects on blood glucose level
Scientific Title	Evaluation of the effects on blood glucose level in Japanese patients with type 2 diabetes who are on diet therapy: a randomized, double-blind, crossover trial
Scientific Title:Acronym	Evaluation of the effects on blood glucose level
Region	Japan

Condition
Condition	Type 2 diabetes (Adult)
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects on change of blood glucose levels with the intake of the test food
Basic objectives2	Others
Basic objectives -Others	The simultaneous studies efficacy and bio-equivalence.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood glucose level * Assess before eating the test food and at 30, 60, 90, and 120 minutes after eating the test food (total 5 times). * Assess the area under curve (AUC), the maximum blood concentration (Cmax), and the blood glucose level between before eating the test food and 120 minutes after eating the test food
Key secondary outcomes	1. Insulin 2. HOMA-beta 3. HOMA-R *1-3 Assess before eating the test food and at 30, 60, 90, and 120 minutes after eating the test food (total 5 times). * Assess the area under curve (AUC), the maximum blood concentration (Cmax), the blood insulin, HOMA-beta and HOMA-R levels between before eating the test food and 120 minutes after eating the test food. HOMA-beta and HOMA-R are calculated by the formulas: HOMA-beta = (fasting blood insulin level x 360) / (fasting blood glucose level - 63) HOMA-R = fasting blood insulin level x fasting blood glucose level / 405

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	6
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Duration: single dose Test material: Test food 1, Test food 2, and Test food 3 Administration: Eat six of each test food in 20 minutes at the examination * Do not drink water with test food <Intervention schedule> [1] Eat Test food 1 [2] Washout period is for more than a day. [3] Eat Test food 2 [4] Washout period is for more than a day. [5] Eat Test food 3
Interventions/Control_2	Duration: same as above Test material: same as above Administration: same as above <Intervention schedule> [1] Eat Test food 2 [2] Washout period is for more than a day. [3] Eat Test food 3 [4] Washout period is for more than a day. [5] Eat Test food 1
Interventions/Control_3	Duration: same as above Test material: same as above Administration: same as above <Intervention schedule> [1] Eat Test food 3 [2] Washout period is for more than a day. [3] Eat Test food 1 [4] Washout period is for more than a day. [5] Eat Test food 2
Interventions/Control_4	Duration: same as above Test material: same as above Administration: same as above <Intervention schedule> [1] Eat Test food 3 [2] Washout period is for more than a day. [3] Eat Test food 2 [4] Washout period is for more than a day. [5] Eat Test food 1
Interventions/Control_5	Duration: same as above Test material: same as above Administration: same as above <Intervention schedule> [1] Eat Test food 1 [2] Washout period is for more than a day. [3] Eat Test food 3 [4] Washout period is for more than a day. [5] Eat Test food 2
Interventions/Control_6	Duration: same as above Test material: same as above Administration: same as above <Intervention schedule> [1] Eat Test food 2 [2] Washout period is for more than a day. [3] Eat Test food 1 [4] Washout period is for more than a day. [5] Eat Test food 3
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Japanese adult people 2. Patients with type 2 diabetes who are on diet therapy 3. Subjects who can obtain the family doctor's consent to the participation in this study if subjects have their family doctors 4. Subjects who can provide the latest blood test data and are allowed to participate in the study by the physician 5. Subjects who are judged as eligible to participate in the study by the physician 6. Within the subjects who met 5th inclusion criteria, subjects who are relatively few items of out-of-reference values in the blood test result at screening
Key exclusion criteria	1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who are anemic 3. Subjects who have dysphagia 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 5. Currently taking medicines (include herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products. 7. Subjects who are pregnant, breast-feeding, and planning to become pregnant 8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 9. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	Naoko
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	KANRO CO.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 10 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	12
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	2018 Year 04 Month 26 Day
Date of IRB	2018 Year 04 Month 26 Day
Anticipated trial start date	2018 Year 05 Month 07 Day
Last follow-up date	2018 Year 07 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 05 Month 01 Day
Last modified on	2022 Year 02 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037004