UMIN-CTR Clinical Trial

Basic information
Public title	A Randomized Controlled Trial of The Effects of Dietary Nitrate Supplementation on Blood Pressure and Maximal Isometric Handgrip Strength in Prehypertensive Women
Acronym	A Randomized Controlled Trial of The Effects of Dietary Nitrate Supplementation on Blood Pressure and Maximal Isometric Handgrip Strength in Prehypertensive Women
Scientific Title	A Randomized Controlled Trial of The Effects of Dietary Nitrate Supplementation on Blood Pressure and Maximal Isometric Handgrip Strength in Prehypertensive Women
Scientific Title:Acronym	A Randomized Controlled Trial of The Effects of Dietary Nitrate Supplementation on Blood Pressure and Maximal Isometric Handgrip Strength in Prehypertensive Women
Region	Asia(except Japan)

Condition
Condition	Prehypertensive
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of 14 days nitrate rich beetroot extract supplementation on the blood pressure responses, maximal isometric handgrip strength and nitric oxide bioavailability in prehypertensive women
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Resting blood pressure (systolic blood pressure, diastolic blood pressure and mean arterial pressure)
Key secondary outcomes	Fractional exhaled nitric oxide (FeNO) Renal function (urea nitrogen, creatine, uric acid) Physical measurements (body weight, body fat percentage, waist circumference, heart beat)

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	Treatment
Type of intervention	Food
Interventions/Control_1	130 mg per kg of subject body weight of beetroot extract
Interventions/Control_2	Placebo capsule not containing beetroot extract
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	60 years-old >
Gender	Female
Key inclusion criteria	(1) persons who is generally judged as prehypertensive (two separate days systolic reading range between 120 mmHg to 139 mmHg, or the diastolic reading between 80 mmHg to 89 mmHg otherwise healthy adult
Key exclusion criteria	(1) persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study (2) persons who have changed their habitats to take supplements within past 4 weeks. (3) Persons who work in night shift or in day and night shift (4) persons who have been treated their illness or prevention in a clinic at their informed consent (5) persons with their medical histories as follows: serious diseases of sugar metabolism, lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system (6) persons with the medical histories of alcoholism or drug dependence (7) persons who might be developed allergic reaction to foods. (8) Persons who are pregnant, breastfeeding, or hope to be pregnant during the study period (9) persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device) (10) persons who will not be judged suitable to the participants by the investigator.
Target sample size	8

Research contact person
Last name of lead principal investigator	1st name Adam Middle name Last name Linoby
Organization	Universiti Teknologi MARA
Division name	Faculty of Sports Science and Recreation
Zip code	70300
Address	UiTM Cawangan Negeri Sembilan, Kampus Seremban, Jalan Seremban Tiga/1, Seremban 3, Seremba n, Negeri Sembilan, Malaysia
TEL	+60133632005
Email	linoby@uitm.edu.my

Public contact
1st name of contact person	1st name Adam Middle name Last name Linoby
Organization	Universiti Teknologi MARA
Division name	Faculty of Sports Science and Recreation
Zip code	70300
Address	UiTM Cawangan Negeri Sembilan, Kampus Seremban, Jalan Seremban Tiga/1, Seremban 3, Seremba n, Negeri
TEL	+60133632005
Homepage URL	https://seremban.uitm.edu.my/
Email	linoby@uitm.edu.my

Sponsor
Institute	Faculty of Sports Science and Recreation, Universiti Teknologi MARA
Institute
Department

Funding Source
Organization	Fundamental Research Grant Scheme, Ministry of Higher Education (Malaysia)
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization	Malaysia

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Faculty of Sports Science and Recreation, Universiti Teknologi MARA
Address	UiTM Cawangan Negeri Sembilan, Kampus Seremban, Jalan Seremban Tiga/1, Seremban 3
Tel	+606-6342409
Email	shari0971@uitm.edu.my

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	2019 Year 06 Month 02 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	9
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	2018 Year 12 Month 01 Day
Date of IRB	2019 Year 03 Month 25 Day
Anticipated trial start date	2019 Year 06 Month 03 Day
Last follow-up date	2020 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 06 Month 02 Day
Last modified on	2019 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042076