UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination about the blood vessel wall function improvement action by the natto intake
Title of the study (Brief title)	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	Naoki Miura
Organization	Miura Clinic, Medical Corporation Kanonkai
Division name	Internal Medicine
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	Makoto Terashima
Organization	Oneness Support Co., Ltd.
Division name	Clinical trial Division
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 08 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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