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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033831
Receipt No. R000038584
Scientific Title Examination about the blood vessel wall function improvement action by the natto intake
Date of disclosure of the study information 2018/08/21
Last modified on 2018/08/21

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Basic information
Public title Examination about the blood vessel wall function improvement action by the natto intake
Acronym Natto intake on vascular endothelial function (NIVE)
Scientific Title Examination about the blood vessel wall function improvement action by the natto intake
Scientific Title:Acronym Natto intake on vascular endothelial function (NIVE)
Region
Japan

Condition
Condition Healthy Adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Vascular endothelial function when feeding Natto for 12 weeks, for adult (aged 40-59) subjects with high-normal blood pressure
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of flow-mediated dilatation (FMD)
Key secondary outcomes Activated PTT,
PT-IR,
Antithrombin,
D Dimer,
Total-Cho,HDL-Cho,LDL-Cho,
TG,
Blood pressure,
Image of capillary

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Natto
Interventions/Control_2
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
59 years-old >=
Gender Male and Female
Key inclusion criteria Healthy men and women of ages 40 to 59 years old subjects with high-normal blood pressure
Key exclusion criteria 1. Persons who has liver disease, renal disease, digestive organ disease, heart trouble, peripheral vascular disorder, a person with a history of the past that may have an influence on other final examination results or person with a history of the operation
2. Person who take warfarin
3. Persons who liver function and renal function test values show abnormalities
4. Currently, those with a disorder under treatment
5. Persons who have food or drug allergy
6. Person who suffer from anemia
7. Persons who do intense sports or are on a diet
8. Persons who can't stop using functional foods (including Food for Specified Health Uses or Foods with Function Claims) and/or Specified quasi-drugs during the current study periods.
9. Persons who are taking health foods, quasi medical items, medicines (including OTC, prescription medicine) containing ingredients contained in the test food
10. Persons who consume excess alcohol or can not abstinence from the day before the test until the day
11. Persons who are pregnant, or persons who are planning to become pregnant or breastfeeding during the study period
12. Persons who are participating in the other study or planning to participate during the study period
13. Persons who judged inappropriate by the study responsible doctor for other reasons
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Miura
Organization Miura Clinic, Medical Corporation Kanonkai
Division name Internal Medicine
Zip code
Address 9F Higashitenma Bldg.,1-7-17 Higashitenma, Kita-ku, Osaka-shi, Osaka, Japan
TEL 06-6135-5200
Email info@miura-cl.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Terashima
Organization Oneness Support Co., Ltd.
Division name Clinical trial Division
Zip code
Address 9F Higashitenma Bldg.,1-7-17 Higashitenma, Kita-ku, Osaka-shi, Osaka, Japan
TEL 06-4801-8917
Homepage URL
Email mterashima@miura-cl.jp

Sponsor
Institute Takanofoods Co., Ltd.
Institute
Department

Funding Source
Organization Takanofoods Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Miura Clinic, Medical Corporation Kanonkai
Oneness Support Co., Ltd.
Department of Cardiovascular Surgery, University of Tsukuba
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 08 Month 21 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
2018 Year 08 Month 18 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 21 Day
Last modified on
2018 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038584

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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