UMIN-CTR Clinical Trial

Basic information
Public title	A study on the effect of vegetable on lowering blood pressure in healthy subjects.
Acronym	A study on the effect of vegetable on lowering blood pressure in healthy subjects.
Scientific Title	A study on the effect of vegetable on lowering blood pressure in healthy subjects.
Scientific Title:Acronym	A study on the effect of vegetable on lowering blood pressure in healthy subjects.
Region	Japan

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

Objectives
Narrative objectives1	A study on the effect of NO3- rich vegetable (spinach, komatsuna (Japanese mustard spinach )) on lowering blood pressure in healthy subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood pressure
Key secondary outcomes	Serum NO3- Serum NO2- Serum Arginine Serum Ornithine Serum Citrulline Serum Arginase Serum HDL cholesterol Serum LDL cholesterol Serum hsCRP

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	1-1 Diet containing a powder of spinach(single ingestion),wash out for over a week,control diet that is free of powder of spinach(single ingestion) 2-1 NOx(NO2-+NO3-) rich vegetable(komatsuna, (Japanese mustard spinach)) 300g(single ingestion ), wash out for over a week, control( no food )
Interventions/Control_2	1-2 Control diet that is free of powder of spinach (single ingestion),wash out for over a week,diet containing a powder of spinach(single ingestion) 2-2 control( no food ), wash out for over a week, NOx(NO2-+NO3-) rich vegetable (komatsuna(Japanese mustard spinach))300g(single ingestion )
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	20 years-old <
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	Healthy subjects. Subjects who sign an informed consent form to participate in the study.
Key exclusion criteria	Use of antihypertensive or cholesterol lowering medication. History of cardiovascular or peripheral vascular disease. Diagnosed type1 or type2 diabetes. History of cancer. Recent history of asthma, renal, liver or gastrointestinal disease. Gain or loss of body weight (>6%) within 6months. Inability or unwilling to consume foods provided in the trial.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Keiki Ogino
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Public Health
Zip code
Address	2-5-1,Shikata-cho,Kita-ku,Okayama,Japan
TEL	086-235-7184
Email	public@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Keiki Ogino
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Public Health
Zip code
Address	2-5-1,Shikata-cho,Kita-ku,Okayama,Japan
TEL	086-235-7184
Homepage URL
Email	public@md.okayama-u.ac.jp

Sponsor
Institute	Department of Public Health ,Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	International Pacific University
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	2014 Year 04 Month 30 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	Terminated
Date of protocol fixation	2014 Year 04 Month 30 Day
Date of IRB	2014 Year 04 Month 30 Day
Anticipated trial start date	2014 Year 05 Month 26 Day
Last follow-up date	2014 Year 05 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 04 Month 30 Day
Last modified on	2022 Year 07 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016154