UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013844 |
|---|---|
| Receipt number | R000016154 |
| Scientific Title | A study on the effect of vegetable on lowering blood pressure in healthy subjects. |
| Date of disclosure of the study information | 2014/04/30 |
| Last modified on | 2022/07/19 17:11:23 |
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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
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
public@md.okayama-u.ac.jp
Sponsor or person
Institute
Department of Public Health ,Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016154
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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