UMIN-CTR Clinical Trial

Basic information
Public title	Study on the effect of food material on blood glucose
Acronym	Study on the effect of food material on blood glucose
Scientific Title	Study on the effect of food material on blood glucose
Scientific Title:Acronym	Study on the effect of food material on blood glucose
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of intake of food material for 7 days on the postprandial blood glucose in Japanese healthy males aged 20-64.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postprandial blood glucose and insulin levels (at start and end of the test)
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test food for 7 days (1 capsule/day)
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	65 years-old >
Gender	Male
Key inclusion criteria	1)Males 20 to 65 years at the time of informed consent 2)Subjects who are healthy and have no chronic physical disease. 3)Subjects who are able to submit the written informed consents. 4)Subjects judged appropriate for the study by the principal.
Key exclusion criteria	1)Subjects who are with treatment. 2)With present heart disorder, liver disorder, or kidney disorder. 3)With previous or present cardiac disorder. 4)With diabetes mellitus. 5)Subjects who regularly use drugs, health foods, and supplements affecting the study 6)Heavy dinker 7)Subjects who have an extremely irregular diet habit (alternative worker, or work on midnight shift). 8)Subjects who experienced unpleasant feeling during drawing blood. 9)Subjects who have allergy related to the study foods 10)Subjects who are deemed to be unsuitable by the investigator.
Target sample size	3

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Ono
Organization	Ueno-Asagao Clinic
Division name	Head
Zip code	110-0015
Address	6F Kairaku Building, 2-7-5 Higashiueno, Taito-ku, Tokyo, Japan
TEL	03-6240-1162
Email	info@ueno-asagao.clinc

Public contact
Name of contact person	1st name Susumu Middle name Last name Yoshino
Organization	Maruzen Pharmaceuticals Co., Ltd.
Division name	Research Center
Zip code	729-3102
Address	1089-8 Sagata, Shin-ichi, Fukuyama, Hiroshima, Japan
TEL	0847-52-5501
Homepage URL
Email	s-yoshino@maruzenpcy.co.jp

Sponsor
Institute	Maruzen Pharmaceuticals Co., Ltd.
Institute
Department

Funding Source
Organization	Maruzen Pharmaceuticals Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ueno-Asagao Clinic Ethical Review Committee
Address	6F Kairaku Building, 2-7-5 Higashiueno, Taito-ku, Tokyo, Japan
Tel	03-6240-1162
Email	jimukyoku@tes-h.co.jp

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

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 01 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	Completed
Date of protocol fixation	2020 Year 07 Month 20 Day
Date of IRB	2020 Year 07 Month 20 Day
Anticipated trial start date	2020 Year 07 Month 31 Day
Last follow-up date	2020 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 07 Month 22 Day
Last modified on	2021 Year 01 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047036