UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048526 |
|---|---|
| Receipt number | R000055292 |
| Scientific Title | Influence of ingestion of nitrate on vascular endothelial function:a randomized, double-blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2022/07/31 |
| Last modified on | 2022/10/08 14:03:46 |
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Basic information
Public title
Influence of ingestion of nitrate on vascular endothelial function:a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym
Effect of nitrate on vascular endothelial function
Scientific Title
Influence of ingestion of nitrate on vascular endothelial function:a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym
Effect of nitrate on vascular endothelial function
Region
| Japan |
Condition
Condition
vascular endothelial function
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the influence of nitrate for vascular endothelial function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
flow-mediated dilatation
Key secondary outcomes
Blood pressure, Heart rate
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Tested material: Beet it
Dosage: 140ml/day
Duration: 1 day
Interventions/Control_2
Tested material: Beet it placebo
Dosage: 140ml/day
Duration: 1 day
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy subjects
Key exclusion criteria
Subjects with
serious liver, kidney, heart, respiratory, endocrine or metabolic diseases/ scheduled for surgery during this study/ regular administration of supplements which affect this study / food allergies/ participation of other clinical trial during this study/ restriction of exercise/ any reason in the opinion of the lead principal investigator not to take part in this study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Eisuke |
| Middle name | |
| Last name | Ochi |
Organization
Hosei University
Division name
Faculty of Bioscience and Applied Chemistry
Zip code
184-8584
Address
3-7-2 Kajino, Koganei, Tokyo
TEL
042-387-6337
ochi@hosei.ac.jp
Public contact
Name of contact person
| 1st name | Eisuke |
| Middle name | |
| Last name | Ochi |
Organization
Hosei University
Division name
Faculty of Bioscience and Applied Chemistry
Zip code
184-8584
Address
3-7-2 Kajino, Koganei, Tokyo
TEL
042-387-6337
Homepage URL
ochi@hosei.ac.jp
Sponsor or person
Institute
Hosei University
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hosei University Sports Research Center IRB
Address
4342, Aihara, Machida, Tokyo
Tel
042-783-2076
tamatai@hosei.ac.jp
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
| 2022 | Year | 07 | Month | 31 | 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
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 10 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 15 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 30 | Day |
Last modified on
| 2022 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055292
