UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033831 |
|---|---|
| Receipt number | 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 11:14:56 |
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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
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
mterashima@miura-cl.jp
Sponsor or person
Institute
Takanofoods Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038584
| 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 |
