UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036925
Receipt number 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 18:35:20

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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 or person

Institute

Faculty of Sports Science and Recreation, Universiti Teknologi MARA

Institute

Department

Personal name



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

Value
https://center6.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