UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Test on the influence of banana intake on time-dependent change of blood glucose level
Title of the study (Brief title)	Test on the influence of banana intake on change of blood glucose level
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Test on the influence of banana intake on time-dependent change of blood glucose level
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood glucose level (AUC, deltaCmax, deltaC, Tmax)
Key secondary outcomes	none

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	5
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingest total 234 g of banana1
Interventions/Control_2	Ingest total 234 g of banana2
Interventions/Control_3	Ingest total 53.3 g of maltodextrin
Interventions/Control_4	Ingest total 150 g of rice
Interventions/Control_5	Ingest total 113 g of bread
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. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2. Healthy Japanese who is 20 years old or more and under 50 years old 3. Persons whose BMI is 30 or less 4. Persons who do not have impaired glucose tolerance in the past one year examination 5. Persons who are not taking drugs such as anti-hypertensive agents
Key exclusion criteria	1. Persons who have a chronic disease and is under medication, or has a serious disease history 2. Persons who are allergic to the test food 3. Persons who participated in other examination during the first month before the start of the exam, or those who plan to participate in other exams following this exam agreement 4. Persons who are breastfeeding, pregnant, scheduled or hoping to be pregnant during the exam period 5. Persons who are judged inappropriate for the exam by the principal investigator
Target sample size	30

Research contact person
Name of lead principal investigator	Hirohito Ishikawa
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	03-6809-2722
Email	ishikawa@hc-sys.jp

Public contact
Name of contact person	Hirohito Ishikawa
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	03-6809-2722
Homepage URL
Email	ishikawa@hc-sys.jp

Sponsor
Institute	Healthcare Systems Co., Ltd.
Institute
Department

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

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

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	2018 Year 04 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 04 Month 02 Day
Anticipated trial start date	2018 Year 04 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 04 Month 02 Day
Last modified on	2018 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036579