UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047748 |
|---|---|
| Receipt number | R000054431 |
| Scientific Title | Study on changes in blood glucose level by ingestion of dried banana powder |
| Date of disclosure of the study information | 2022/05/13 |
| Last modified on | 2022/11/14 09:05:59 |
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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
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
asahina.yuki@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
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
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
53
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
| 2022 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 13 | Day |
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 | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054431
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
