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

Hypertension Clinical Trial

Official title:

Acute Effects of Beet Juice Intake on Vascular Function in Treated Hypertensive Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04020796
• Other study ID #: BRJ-700
• Status: Completed
• Phase: N/A
• Start date: June 20, 2019
• Est. completion date: August 15, 2019

Study information

• Verified date: July 2020
• Source: Hospital Universitario Pedro Ernesto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 15, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Brazil	Samanta de Souza Mattos	Rio de Janeiro	RJ

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitario Pedro Ernesto	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microvascular reactivity	A laser speckle contrast imaging system with a laser wavelength of 785 nm system will measure non-invasively real time cutaneous microvascular flow changes in the forearm. For the post occlusive reactive hyperemia test, arterial occlusion will be performed with suprasystolic pressure (50 mmHg above the systolic arterial pressure) using a sphygmomanometer applied to the arm of the subject over three minutes. Peak skin flow will be measured after pressure release.	150 minutes
Secondary	Central blood pressure	Central systolic blood pressure, diastolic blood pressure, mean arterial pressure and pulse pressure before and after intervention and their potential effects on changes in subendocardial viability ratio and ejection duration after intervention with beetroot juice and water.	150 minutes