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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045655
Receipt No. R000052119
Scientific Title Evaluation study of visceral fat and inflammatory markers by intake of banana
Date of disclosure of the study information 2021/10/04
Last modified on 2021/10/15

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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 Preinitiation
Date of protocol fixation
2021 Year 10 Month 01 Day
Date of IRB
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 10 Month 15 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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