UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045655 |
|---|---|
| Receipt number | 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 | 2021/12/17 15:14:17 |
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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
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
asahina.yuki@hc-sys.jp
Sponsor or person
Institute
Akasaka Family Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052119
