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出境医 / 临床实验 / Acute Effects of Beet Juice Intake on the Vascular Function of Hypertensive Patients

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Hypertension Dietary Supplement: Beetroot juice Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: randomized, crossover, placebo-controlled
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Acute Effects of Beet Juice Intake on Vascular Function in Treated Hypertensive Patients
Actual Study Start Date : June 20, 2019
Actual Primary Completion Date : July 30, 2019
Actual Study Completion Date : August 15, 2019
Arms and Interventions
Arm Intervention/treatment
Active Comparator: 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.
 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.
Placebo Comparator: 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.
 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.
Outcome Measures
Primary Outcome Measures :
  1. Microvascular reactivity [ Time Frame: 150 minutes ]
    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.


Secondary Outcome Measures :
  1. Central blood pressure [ Time Frame: 150 minutes ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Locations
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Brazil
Samanta de Souza Mattos
Rio de Janeiro, RJ, Brazil, 20551-030
Sponsors and Collaborators
Hospital Universitario Pedro Ernesto
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Principal Investigator: Samanta S Mattos State University of Rio de Janeiro
Study Director: Mario F Neves, MD, PhD State University of Rio de Janeiro
Tracking Information
First Submitted Date  ICMJE June 28, 2019
First Posted Date  ICMJE July 16, 2019
Last Update Posted Date July 28, 2020
Actual Study Start Date  ICMJE June 20, 2019
Actual Primary Completion Date July 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019) 		Microvascular reactivity [ Time Frame: 150 minutes ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2019) 		Central blood pressure [ Time Frame: 150 minutes ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Effects of Beet Juice Intake on the Vascular Function of Hypertensive Patients
Official Title  ICMJE Acute Effects of Beet Juice Intake on Vascular Function in Treated Hypertensive Patients
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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
randomized, crossover, placebo-controlled
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Hypertension
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: 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.
    Intervention: Dietary Supplement: Beetroot juice
  • Placebo Comparator: 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.
    Intervention: Dietary Supplement: Beetroot juice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2019) 		37
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 15, 2019
Actual Primary Completion Date July 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04020796
Other Study ID Numbers  ICMJE BRJ-700
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plans to share IPD with other researchers
Responsible Party Samanta De Souza Mattos, Hospital Universitario Pedro Ernesto
Study Sponsor  ICMJE Hospital Universitario Pedro Ernesto
Collaborators  ICMJE
  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators  ICMJE
Principal Investigator: Samanta S Mattos State University of Rio de Janeiro
Study Director: Mario F Neves, MD, PhD State University of Rio de Janeiro
PRS Account Hospital Universitario Pedro Ernesto
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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