UMIN-CTR Clinical Trial

Public title

Evaluation test on the influence of intake banana on changes of Intestinal flora and Vitamin B6.

Acronym

Evaluation test on the influence of intake banana on changes of Intestinal flora and Vitamin B6.

Scientific Title

Evaluation test on the influence of intake banana on changes of Intestinal flora and Vitamin B6.

Scientific Title:Acronym

Evaluation test on the influence of intake banana on changes of Intestinal flora and Vitamin B6.

Region

Japan

Condition

Healthy Adults

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Evaluate the changes of Intestinal flora and Vitamin B6 by banana intake for 4 weeks.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

-Intestinal flora
-Vitamin B6
At the beginning of the test or after the intake for 4weeks.

Key secondary outcomes

-AGEs
-Blood test (total protein, albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, blood neutral fat (TG), urea nitrogen , creatinine, uric acid, AST, ALT, ALP,HbA1c, sodium, potassium, chlorine, calcium, magnesium, phosphorus, serum iron, complete blood count)
-Physical examination (body weight, BMI)
-Blood pressure (systolic blood pressure, diastolic blood pressure),Pulse
At the beginning of the test or after the intake for 4weeks.

Study type

Interventional

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

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of 2 bananas daily for 4 weeks.

Interventions/Control_2

none

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

30

years-old

<=

Age-upper limit

64

years-old

>

Gender

Male and Female

Key inclusion criteria

1.Persons who received a sufficient explanation of the purpose and contents of the study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Male and female who are 30 years old or more and under 64 years old

Key exclusion criteria

1.Persons who have any disease and are judged to have necessary treatment by the principal investigator.
2.Persons who have severe anemia.
3.Persons who are pregnant, planning or hoping to be pregnant during the study period, currently lactating.
4.Persons who may cause allergic symptoms to test foods.
5.Persons who have an addiction to alcohol or a mental disease.
6.Persons who are smokers or have been smoking within last 10 years.
7.Persons whose life style will change during the study period.
8.Persons who plan to intake new health functional foods and supplement foods during the study period.
9.Persons who were hospitalized and received treatment in the past 6 months.
10.Persons who participate in other clinical studies or participated in the last 3 months or plan to participate in other clinical studies.
11. Persons who were judged as inappropriate for subjects by the principal investigator.

Target sample size

34

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. 3F, 2-15-15 Akasaka, Minato-ku, Tokyo, JAPAN

TEL

03-5562-8825

Email

info@afc.tokyo

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

Institute

Akasaka Family Clinic

Institute

Department

Personal name

Organization

Japan Banana Importers Association.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

05

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2020

Year

05

Month

22

Day

Date of IRB

2020

Year

05

Month

22

Day

Anticipated trial start date

2020

Year

06

Month

22

Day

Last follow-up date

2020

Year

08

Month

03

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

05

Month

26

Day

Last modified on

2020

Year

11

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046259