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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036602
Receipt No. 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 2019/04/24

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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
Email 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
Email yoshi@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

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
Email 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
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
2019 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 07 Day
Last follow-up date
2019 Year 08 Month 03 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
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041680

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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