UMIN-CTR Clinical Trial

Basic information
Public title	Test on the influence of continuous banana intake on changes of blood pressure and defecation status.
Acronym	Test on the influence of banana intake on blood pressure and defecation status.
Scientific Title	Test on the influence of continuous banana intake on changes of blood pressure and defecation status.
Scientific Title:Acronym	Test on the influence of banana intake on blood pressure and defecation status.
Region	Japan

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

Objectives
Narrative objectives1	Explore the effects of banana intake for 4 weeks on suppression effect for high blood pressure and improvement effect for defecation status.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood pressure (systolic blood pressure, diastolic blood pressure) at the beginning of the test or after ingestion of four weeks.
Key secondary outcomes	-Pulse -General blood biochemical test (total protein, albumin, total cholesterol, blood neutral fat (TG), HDL-cholesterol, LDL-cholesterol, AST(GOT), ALT(GPT), ALP, gamma-GTP, CPK, total bilirubin, uric acid, urea nitrogen, creatinine, sodium, potassium, chlorine, calcium, phosphorus, magnesium, LDH) -Physical examination (body height, weight, BMI) -Questionnaire on defecation -Questionnaire about mental condition (VAS) at the beginning of the test or after ingestion of four weeks.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake 120g (edible part only) of banana A daily for 4 weeks.
Interventions/Control_2	Intake 120g (edible part only) of banana B daily for 4 weeks.
Interventions/Control_3	none
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 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 are 20 to 64 years old 3.Persons with systolic blood pressure less than 180 mmHg and diastolic blood pressure less than 110 mmHg 4.Persons who satisfy 3 and the top of systolic blood pressure during the pre-intake test
Key exclusion criteria	1.Persons who have a chronic disease and is under medication, or has a serious disease history 2.Persons who regularly use medicines, specified insurance foods, health foods, etc. that may affect blood pressure and defecation status 3.Persons who are allergic to the test food 4.Persons who have a history of hypertension treatment 5.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 6.Persons who are judged inappropriate for the exam by the principal investigator
Target sample size	81

Research contact person
Name of lead principal investigator	1st name Takamasa Middle name Last name Masuda
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development Department
Zip code	105-0004
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	03-6809-2722
Email	masudat@hc-sys.jp

Public contact
Name of contact person	1st name Takamasa Middle name Last name Masuda
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development Department
Zip code	105-0004
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	03-6809-2722
Homepage URL
Email	masudat@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)

IRB Contact (For public release)
Organization	The Ethics Committee of Healthcare Systems Co., Ltd.
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel	03-6809-2722
Email	kakehashi@hc-sys.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	2019 Year 12 Month 06 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	2019 Year 12 Month 04 Day
Date of IRB	2019 Year 12 Month 04 Day
Anticipated trial start date	2019 Year 12 Month 21 Day
Last follow-up date	2020 Year 05 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	2019 Year 12 Month 06 Day
Last modified on	2020 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044245