UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051716 |
|---|---|
| Receipt number | R000059023 |
| Scientific Title | An exploratory study on the improvement of vascular endothelial function by ingestion of plant extract-containing foods -A randomized, open-label, parallel-group comparative exploratory study- |
| Date of disclosure of the study information | 2023/08/20 |
| Last modified on | 2023/09/06 11:59:02 |
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Basic information
Public title
A study to investigate the effects of plant extract-containing foods on vascular endothelial function
Acronym
Vascular Endothelial Function Study of Foods Containing Plant Extracts
Scientific Title
An exploratory study on the improvement of vascular endothelial function by ingestion of plant extract-containing foods -A randomized, open-label, parallel-group comparative exploratory study-
Scientific Title:Acronym
Exploratory study on improvement of vascular endothelial function by ingestion of plant extract-containing foods
Region
| Japan |
Condition
Condition
Vascular endothelial function
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using the vascular endothelial function LnRHI score measured by EndoPAT2000 as the evaluation index, the effects of low-dose and high-dose plant extract intakes for 180 days on the improvement of vascular endothelial function in the pre-arteriosclerotic stage of healthy subjects are compared among no-intake group, low-dose group, and high-dose group. Based on the difference between the intake groups and the no-intake group obtained from the study, a large-scale clinical study is designed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
LnRHI score change
Key secondary outcomes
End LnRHI, Intake rate of research target food
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
No intake group (180 days)
Interventions/Control_2
Low-dose group: plant extract 40 mg/day intake (180 days)
Interventions/Control_3
High-dose group: 80 mg/day intake of plant extract (180 days)
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Those aged 30 to 75
2.Of those who underwent the EndoPAT test in 2022, those who underwent a specific medical examination in Arita Town, Saga Prefecture in 2023
Key exclusion criteria
1. Among EndoPAT test recipients in 2022, those who are undergoing treatment for hypertension, diabetes, and dyslipidemia
2.Subjects with a history of allergy to polyphenol-containing foods
3. Subjects who have a habit of taking health foods that contain ingredients that affect vascular endothelial function on a daily basis
4.Things in which the probe cannot be attached
5.Those who are pregnant, may be pregnant, or are breastfeeding
6. Others judged to be ineligible by the principal investigator
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Ide |
Organization
Kyushu University
Division name
Department of Coronary Artery Disease
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka City
TEL
092-642-5360
ide.tomomi.117@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Terauchi |
Organization
HuBit genomix,Inc.
Division name
Business Department
Zip code
104-0045
Address
7-10-2 Tukiji,Chuo-ku,Tokyo
TEL
03-5148-3990
Homepage URL
mterauchi@hubitgenomix.com
Sponsor or person
Institute
HuBit genomix,Inc.
Institute
Department
Personal name
Funding Source
Organization
HuBit genomix,Inc. TOYO SHINYAKU Co.,Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
HuBit genomix,Inc.
Address
7-10-2 Tukiji,Chuo-ku,Tokyo,104-0045
Tel
03-5148-3990
mterauchi@hubitgenomix.com
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
| 2023 | Year | 08 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 26 | Day |
Last modified on
| 2023 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059023
| 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 |
