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

NCT04020796 | Completed DMC

• 1 other identifier: BRJ-700
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Central blood pressure

  150 minutes

Study Arms (2)

Beetroot juice

ACTIVE COMPARATOR

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.

Dietary Supplement: Beetroot juice

Mineral water

PLACEBO COMPARATOR

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.

Dietary Supplement: Beetroot juice

Interventions

Beetroot juice 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.

Beetroot juice; Mineral water

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Pedro Ernesto: lead
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Samanta de Souza Mattos

Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Samanta S Mattos

  State University of Rio de Janeiro

  PRINCIPAL INVESTIGATOR

• Mario F Neves, MD, PhD

  State University of Rio de Janeiro

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nutritionist

Model Details: randomized, crossover, placebo-controlled

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 16, 2019
• Study Start: June 20, 2019
• Primary Completion: July 30, 2019
• Study Completion: August 15, 2019
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)