UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036602 |
|---|---|
| Receipt number | R000041680 |
| Scientific Title | A Study on the Effect of Food Containing Plant Extract on Vascular Endothelial Function. -A Ramdomized, Double-blind, Placebo-controlled, Parallel-group Study- |
| Date of disclosure of the study information | 2019/05/06 |
| Last modified on | 2021/02/17 10:41:34 |
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Basic information
Public title
A Study on the Effect of Food Containing Plant Extract on Vascular Endothelial Function.
-A Ramdomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym
A Study on the Effect of Food Containing Plant Extract on Vascular Endothelial Function.
Scientific Title
A Study on the Effect of Food Containing Plant Extract on Vascular Endothelial Function.
-A Ramdomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym
A Study on the Effect of Food Containing Plant Extract on Vascular Endothelial Function.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of food containing plant extract on vascular endothelial function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FMD
Key secondary outcomes
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Food containing plant extract, 8 weeks consumption.
Interventions/Control_2
Food not containing plant extract, 8 weeks consumption.
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females aged 40 to 64 years-old.
(2) Subjects whose BMI are less than 30.
(3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
(1) Subjects who contract chronic disease and are under treatment.
(2) Subjects who can't stop using medicines, quasi-drugs, supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting blood pressure, lipid metabolism, blood sugar level, body fat, and so on during test periods.
(3) Subjects who have a history of and/or contract serious diseases (eg, liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease and/or metabolic disease).
(4) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption.
(5) Subjects who are judged as unsuitable for the current study by screening tests.
(6) Subjects who are diagnosed as arrhythmia by the screening tests.
(7) Subjects who are shiftworker and/or midnight-shift worker.
(8) Subjects who have declared allergic reaction to ingredients of test foods.
(9) Subjects who have excessive alcohol intake more than approximately 60 g/day of pure alcohol equivalent or habit of drinking not less than 5 days a week.
(10) Subjects who have a history of and/or contract drug addiction and/or alcoholism.
(11) Subjects who can't stop drinking from 2 days before each measurement.
(12) Subjects who have been pregnant or have a plan to become pregnant, or breast feed during the study period.
(13) Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study.
(14) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study.
(15) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Tokushima |
Organization
Maebashi North Hospital
Division name
Director
Zip code
371-0054
Address
692 Shimohosoi-machi,Maebashi-shi,Gumma
TEL
027-235-3333
sagawa@mc-connect.co.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
TOYO SHINYAKU 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.co.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
| 2019 | Year | 05 | Month | 06 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041680
Publication of results
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0386-3603/48050/853
Number of participants that the trial has enrolled
40
Results
Statistically significant difference was confirmed in the primary outcome.
Results date posted
| 2020 | Year | 09 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Males and females aged 40 to 64 years old.
Participant flow
Enrolled(n=40)
Completed(n=40)
Analysed(n=35)
Adverse events
No adverse events were observed that be related to test food.
Outcome measures
FMD
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 25 | Day |
Last modified on
| 2021 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041680
