UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049029 |
|---|---|
| Receipt number | R000055835 |
| Scientific Title | Research of the effect of Black soybean peel extract intake on vasular function |
| Date of disclosure of the study information | 2022/09/30 |
| Last modified on | 2022/12/15 15:02:06 |
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Basic information
Public title
Association of Black soybean peel extract with vascular function
Acronym
Association of Black soybean peel extract with vascular function
Scientific Title
Research of the effect of Black soybean peel extract intake on vasular function
Scientific Title:Acronym
Research of the effect of Black soybean peel extract intake on vasular function
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether Black soybean peel extract has the ability to improve vascular function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endopoint of this study is to discover any alteration of cognitive function in healty adults assessed by Pulse Wave Velocity (PWV) following 4 and 8 weeks oral administration of Black soybean peel extract.
Key secondary outcomes
Body composition (body fat, bone mass, lean body mass)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
100 mL of Black soybean peel extract drink, once a day for 8 weeks
Interventions/Control_2
100 mL of Placebo, once a day for 8 weeks
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects who component to consent and give voluntary consent in writing with full understanding after receiving explanation of this study aim and contents.
Key exclusion criteria
1) Subjects who are under treatment for chronic disorders
2) Body mass index (BMI) less than 18.5 or greater than 30
3) Subjects who are allergic to black soybean
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Kido |
Organization
KINDAY University
Division name
Laboratory of Clinical Nutrition, Department of Food Science and Nutition, Faculty of Agriculture
Zip code
631-8505
Address
3327-204, Nakamachi, NARA 631-8505, JAPAN
TEL
0742-43-8006
skido@nara.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Shisnuke |
| Middle name | |
| Last name | Kido |
Organization
KINDAY University
Division name
Laboratory of Clinical Nutrition, Department of Food Science and Nutition, Faculty of Agriculture
Zip code
631-8505
Address
3327-204, Nakamachi, NARA 631-8505, JAPAN
TEL
0742-43-8006
Homepage URL
skido@nara.kindai.ac.jp
Sponsor or person
Institute
KINDAY University
Institute
Department
Personal name
Funding Source
Organization
Otsuka Food 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 Faculty of Agriculture, KINDAI University
Address
3327-204, Nakamachi, NARA 631-8505, JAPAN
Tel
0742-43-1894
syomu-info@nara.kindai.ac.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 | 09 | Month | 30 | 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
| 2022 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 20 | 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 | 09 | Month | 27 | Day |
Last modified on
| 2022 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055835
| Research Plan | |
|---|---|
| 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 |
