UMIN-CTR Clinical Trial

Basic information
Public title	Study on changes in blood glucose level by ingestion of dried banana powder
Acronym	Study on changes in blood glucose level by ingestion of dried banana powder
Scientific Title	Study on changes in blood glucose level by ingestion of dried banana powder
Scientific Title:Acronym	Study on changes in blood glucose level by ingestion of dried banana powder
Region	Japan

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

Objectives
Narrative objectives1	To examine the effect of 8-week continuous ingestion of dried banana powder on fasting blood glucose levels and the effect of an acute ingestion of dried banana powder on postprandial blood glucose levels in 20 to 50 years old adults.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fasting blood glucose levels HbA1c
Key secondary outcomes	Postprandial blood glucose levels (delta AUC, delta Cmax, delta C, Tmax Fasting insulin levels Anthropometric measurements (body mass and BMI) Feelings of fullness (fullness, hunger, satisfaction, appetite score) Defecation condition (frequency, amount, stool form, smell, feeling of exhilaration)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingest test food A (25g dried banana powder) and carbohydrate tolerance foods on a single day for an acute trial and ingest test food A daily for 8 weeks for a chronic trial
Interventions/Control_2	Ingest test food B (21.2g starch and sucrose mixed powder) and carbohydrate tolerance foods on a single day for an acute trial and ingest test food B daily for 8 weeks for a chronic trial
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	20 years-old <=
Age-upper limit	50 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Persons who provide written informed consent to participate in this study 2.Japanese men and women who are between 20 and 50 years old 3.Persons who have less than 126 mg/dL of fasting blood glucose 4.Persons who have no glucose intolerance within the past year (persons who have never been diagnosed or indicated as diabetes or pre-diabetes) 5.Persons who meet the above criteria with a fasting blood glucose level in the top 60
Key exclusion criteria	1.Persons who have BMI of less than 18 kg/m2 or more than 30 kg/m2 2.Persons who have any chronic illnesses with medication and who have any serious disease histories 3.Persons who have any allergies to the ingredients used in the test food or dairy products 4.Persons who regularly take large amounts of the test food 5.Persons who regularly use medicines or foods with health claims (foods for specified health use, foods with functional claims and foods with nutritional claims) etc., that may affect blood glucose level 6.Persons who have participated in other tests within the past one month before the start of test, or those who intend to participate in another exam after consenting to the exam 7.Persons who were judged as inappropriate for study participant by the principal investigator 8.Persons who are breast-feeding, pregnant and planning or wishing to become pregnant during the study period
Target sample size	60

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

Public contact
Name of contact person	1st name Yuki Middle name Last name Asahina
Organization	Healthcare Systems Co., Ltd.
Division name	Clinical Research 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	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	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	2022 Year 05 Month 13 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	2022 Year 05 Month 13 Day
Date of IRB
Anticipated trial start date	2022 Year 05 Month 14 Day
Last follow-up date	2022 Year 07 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 05 Month 13 Day
Last modified on	2022 Year 05 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054431

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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