UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation study of visceral fat and inflammatory markers by intake of banana
Acronym	Evaluation study of visceral fat and inflammatory markers by intake of banana
Scientific Title	Evaluation study of visceral fat and inflammatory markers by intake of banana
Scientific Title:Acronym	Evaluation study of visceral fat and inflammatory markers by intake of banana
Region	Japan

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

Objectives
Narrative objectives1	Investigate the effects of banana intake for one month on visceral fat area and inflammatory markers in blood in a randomized parallel group comparison study for subjects with BMI of 24 or higher.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in visceral fat area 4 weeks after the start of ingestion
Key secondary outcomes	Fasting blood index (total protein, albumin, total cholesterol, LDL cholesterol, HDL cholesterol, neutral fat, urea nitrogen, creatinine, uric acid, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), serum insulin, glycoalbumin, sodium, potassium, chlorine, calcium, magnesium, inorganic phosphorus, serum iron, blood count, high-sensitivity CRP, interleukin 6, ferritin) Body composition (body weight, BMI, lean body mass) Blood pressure (systolic blood pressure, diastolic blood pressure)

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingest 2 bananas (about 120g of edible portion) every day for 4 weeks by 20:00 at non-specified time. There are no restrictions on the usual meal time.
Interventions/Control_2	Do not ingest bananas for 4 weeks. There are no restrictions on the usual meal time.
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	21 years-old <=
Age-upper limit	45 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 21 years old or more and under 44 years old at the time of obtaining consent 3.Persons who have BMI of 24 or more at the time of obtaining consent
Key exclusion criteria	1.Persons who are currently suffering from some kind of disease and are judged by the investigator to need treatment 2.Persons with severe anemia 3.Pregnant, lactating, pregnant 4.Persons who may cause allergic symptoms to the ingredients contained in the test food 5.Persons with alcoholism or other mental disorders 6.Persons who have a smoking habit, those who have quit smoking for less than 10 year 7. Persons who may change their lifestyle during the examination period (night shift, long trip, etc.) 8.Persons who may develop seasonal allergic symptoms such as pollinosis during the test period 9.Persons who plan to take new health foods and supplement foods during the examination period 10.Persons who have received hormone replacement therapy within the past 6 months 11.Persons who have been treated with hospitalization within the past 6 months 12.Persons who participate in other clinical studies or participated in the last 3 months or plan to participate in other clinical studies. 13.Persons who are judged by the investigator to be inappropriate for this study.
Target sample size	36

Research contact person
Name of lead principal investigator	1st name Mitsuko Middle name Last name Ito
Organization	Akasaka Family Clinic
Division name	Clinic Director
Zip code	107-0052
Address	Akasaka Plaza Bldg., 3rd Floor, Akasaka 2-15-15, Minato-ku, Tokyo
TEL	03-5562-8825
Email	info@afc.tokyo

Public contact
Name of contact person	1st name Yuki Middle name Last name Asahina
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	asahina.yuki@hc-sys.jp

Sponsor
Institute	Akasaka Family Clinic
Institute
Department

Funding Source
Organization	Japan Banana Importers Association.
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	soumu@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	2021 Year 10 Month 04 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	2021 Year 10 Month 01 Day
Date of IRB	2021 Year 10 Month 01 Day
Anticipated trial start date	2021 Year 10 Month 18 Day
Last follow-up date	2021 Year 12 Month 06 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 10 Month 04 Day
Last modified on	2021 Year 12 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052119