Acute Effects of Beet Juice Intake on the Vascular Function of Hypertensive Patients

NCT ID: NCT04020796

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-20

Study Completion Date

2019-08-15

Brief Summary

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To assess the acute effects of only one dose of beet juice on hypertensive subjects treated with vascular endothelial function parameters, using the microvascular reactivity method.

Detailed Description

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Systemic arterial hypertension is an established risk factor for cardiovascular disease (CVD). Among the main modifiable environmental factors of hypertension, the investigators highlight inadequate eating habits, such as low vegetable consumption. Clinical studies have shown that inorganic nitrate from beet juice intake has a protective effect against CVD due to reduced blood pressure, inhibition of platelet aggregation and prevention of endothelial dysfunction. However, there is still no consensus on its benefits of inorganic nitrate in vascular health. Associated with this, there are no previous studies in the literature that correlate the acute effects of inorganic nitrate intake on endothelial function assessed by microvascular reactivity through laser. The objective of the present study is to evaluate the acute effects (single dose) of inorganic nitrate, through the ingestion of beet juice, in the vascular parameters and endothelial function of treated hypertensive patients of both sexes.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

randomized, crossover, placebo-controlled
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Beetroot juice

Randomized cross-over trial. Thirty-seven hypertension, age 40-70 years were randomized to receive a 500ml volume of beetroot juice in a single moment.

Group Type ACTIVE_COMPARATOR

Beetroot juice

Intervention Type DIETARY_SUPPLEMENT

Thirty-seven hypertension, with age 40-70 years were randomized to receive a 500ml volume of beetroot juice contains 11.5 mmol of inorganic nitrate or mineral water in a single moment.

Mineral water

Randomized cross-over trial. Thirty-seven hypertension, age 40-70 years were randomized to receive a 500ml volume of mineral water in a single moment.

Group Type PLACEBO_COMPARATOR

Beetroot juice

Intervention Type DIETARY_SUPPLEMENT

Thirty-seven hypertension, with age 40-70 years were randomized to receive a 500ml volume of beetroot juice contains 11.5 mmol of inorganic nitrate or mineral water in a single moment.

Interventions

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Beetroot juice

Thirty-seven hypertension, with age 40-70 years were randomized to receive a 500ml volume of beetroot juice contains 11.5 mmol of inorganic nitrate or mineral water in a single moment.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients of both sexes
* Age between 40 and 70 years
* Previous diagnosis of primary systemic arterial hypertension
* Signed the Informed Consent Term.

Exclusion Criteria

* Secondary hypertension
* Systolic blood pressure greater than or equal to 180 mmHg or diastolic BP greater than or equal to 110 mmHg
* In use of beta-blockers
* Diabetes mellitus
* History of cancer
* Use of any dietary supplement
* Any serious life-threatening illness
* Cardiovascular diseases
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rio de Janeiro State Research Supporting Foundation (FAPERJ)

OTHER_GOV

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Hospital Universitario Pedro Ernesto

OTHER

Sponsor Role lead

Responsible Party

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Samanta De Souza Mattos

Nutritionist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samanta S Mattos

Role: PRINCIPAL_INVESTIGATOR

State University of Rio de Janeiro

Mario F Neves, MD, PhD

Role: STUDY_DIRECTOR

State University of Rio de Janeiro

Locations

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Samanta de Souza Mattos

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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BRJ-700

Identifier Type: -

Identifier Source: org_study_id

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