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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048020
Receipt No. R000054735
Scientific Title Effect of Daily Ingestion of the Test Food on Improving Vascular Endothelial Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
Date of disclosure of the study information 2022/06/15
Last modified on 2022/06/10

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Basic information
Public title Effect of Daily Ingestion of the Test Food on Improving Vascular Endothelial Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
Acronym Beneficial Effect of the Test Food on Improving Vascular Endothelial Function.
Scientific Title Effect of Daily Ingestion of the Test Food on Improving Vascular Endothelial Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
Scientific Title:Acronym Beneficial Effect of the Test Food on Improving Vascular Endothelial Function.
Region
Japan

Condition
Condition Healthy Adult
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To prove improving vascular endothelial function and safety associated with 8 weeks daily ingestion of test food, in a double-blind, placebo-controlled, parallel group comparison study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Flow-mediated dilation
Key secondary outcomes Sleep and stress questionnaires, home blood pressure

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 NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Daily ingestion 1 capsule of active test food for 8 weeks.
Interventions/Control_2 Daily ingestion 1 capsule of placebo test food 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
40 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1. Subjects who agree to participate in this study with a written informed consent.
2. Japanese males and postmenopausal females between 40 and 65 years old.
3. Subjects whose FMD values are relatively low.
Key exclusion criteria 1. Subjects with difficulty measuring flow- mediated dilation.
2. Subjects whose BMI is >=30 kg/m2.
3. Subjects who are under physician's advice, treatment, and/or medication for hypertension, dyslipidemia and/or diabetes.
4. Subjects with implantable electronic medical devices.
5. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
6. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
7. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data.
8. Subjects with severe anemia.
9. Pre- or post-menopausal women complaining of obvious physical changes.
10. Subjects who are at risk of having allergic reactions to drugs or foods.
11. Subjects who regularly take medicine, functional foods, and/or supplements which would affect blood vessel function and/or blood pressure.
12. Smokers, alcohol addicts or subjects with disordered lifestyle.
13. Subjects who donated either 400 ml whole blood within 16 wks (women), 12 wks (men), 200 ml whole blood within 4 wks, or blood components within 2 wks, prior to this study.
14. Pregnant or lactating women or women who expect to be pregnant.
15. Subjects who currently participate in other clinical trials, or participated within the last 4 wks prior to this study.
16. Any other medical and/or health reasons unfavorable to participation in this study, as judged by the principal investigator.
Target sample size 36

Research contact person
Name of lead principal investigator
1st name Naoyuki
Middle name
Last name HONMA
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code 069-8585
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4430
Email hisc-acad.res@s.do-johodai.ac.jp

Public contact
Name of contact person
1st name Naoyuki
Middle name
Last name HONMA
Organization Hokkaido Information University
Division name Health Information Science Center
Zip code 069-8585
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4430
Homepage URL
Email hisc-acad.res@s.do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

Funding Source
Organization National Agriculture and Food Research Organization
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) TAISHO PHARMACEUTICAL CO., LTD.

IRB Contact (For public release)
Organization The ethics committee of Hokkaido Information University
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel 011-385-4411
Email soumu@do-johodai.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 北海道情報大学 保健センター(北海道)

Other administrative information
Date of disclosure of the study information
2022 Year 06 Month 15 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
2022 Year 05 Month 27 Day
Date of IRB
2022 Year 05 Month 27 Day
Anticipated trial start date
2022 Year 07 Month 07 Day
Last follow-up date
2022 Year 11 Month 11 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 06 Month 10 Day
Last modified on
2022 Year 06 Month 10 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054735

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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