UMIN-CTR Clinical Trial

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
Email	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
Email	ochi@hosei.ac.jp

Sponsor
Institute	Hosei University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055292