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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036925
Receipt No. R000042076
Scientific Title A Randomized Controlled Trial of The Effects of Dietary Nitrate Supplementation on Blood Pressure and Maximal Isometric Handgrip Strength in Prehypertensive Women
Date of disclosure of the study information 2019/06/02
Last modified on 2019/06/02

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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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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