search
Back to results

NO3-rich Beet Juice and Exercise on Postmenopausal Women Cardiovascular Health

Primary Purpose

Arterial Hypertension, Postmenopausal; Menorrhagia, Cardiovascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Beetroot juice rich in nitrate
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Arterial Hypertension

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women with 50 to 65 old years;
  • Physically inactive;
  • Postmenopausal diagnosis (amenorrhea for 12 months or more);
  • Arterial hypertension diagnosis (previously);
  • Systolic blood pressure values >120mmHg up to 159mmHg and diastolic blood pressure values >80mmHg up to 99mmHg.

Exclusion Criteria:

  • Previous history of acute myocardial infarction and/or stroke;
  • Allergy or intolerance to nitrate, gluten, or milk;
  • Medications (proton pump inhibitors, beta-blockers, calcium channels antagonists).

Sites / Locations

  • EEFERP - USP / Laboratório de Fisiologia do Exercício e MetabolismoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Beet protocol

Placebo protocol

Arm Description

Acute intervention: 1st day [140 ml - Beet It Juice, 800mg nitrate/day] Continued intervention: 2nd to 7th day [70 ml - Beet It Juice, 400mg nitrate/day] Exercise intervention [Treadmill - 40 minutes duration, 65% - 70% VO2 Peak]: Acute [Just on day] / Continued [First and latest day] Washout: 7 days

Acute intervention (1st day): [140 ml - Beet It Juice, 0mg nitrate/day] Continued intervention (2nd to 7th day): [70 ml - Beet It Juice, 0mg nitrate/day] Exercise intervention [Treadmill - 40 minutes duration, 65% - 70% VO2 Peak]: Acute [Just on day] / Continued [First and latest day] Washout: 7 days

Outcomes

Primary Outcome Measures

Values of systolic and diastolic blood pressure (mmHg)

Secondary Outcome Measures

Values of heart rate variability (ms)
Values of heart rate (beats per minute)
Macrovascular function (Flow mediated dilatation%)
Plasmatic concentrations of nitrate and nitrite (mmol/L)
Blood concentration of Adiponectin (ug/mL)
Blood concentration of Hormone-sensitive lipase (mmol/min per kg DM)
Blood concentrations of C-reactive protein, Interleukin-6 and Interleukin-10 (ng/mL)
Blood concentrations of Epinephrine and Norepinephrine (pg/mL)

Full Information

First Posted
April 17, 2022
Last Updated
January 10, 2023
Sponsor
University of Sao Paulo
search

1. Study Identification

Unique Protocol Identification Number
NCT05384340
Brief Title
NO3-rich Beet Juice and Exercise on Postmenopausal Women Cardiovascular Health
Official Title
Nitrate-rich Beet Juice Intake and Aerobic Exercise on Cardiovascular Health of Postmenopausal Women With Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In the context of physical exercise, there is no evidence of the acute and continued use of beetroot juice with a previously recommended dose of nitrate (NO3) (>300mg) on the cardiovascular performance of hypertensive and postmenopausal women. We will investigate the effects of beetroot juice rich in NO3 acutely (first day: 140mL/800mg) and during a week with daily doses (second to the seventh day: 70mL/400mg) on blood pressure, heart rate (HR), cardiac autonomic control, EF, inflammatory, hormonal, and stress biomarkers oxidative stress and enzymes involved in nitric oxide synthesis and mitochondrial regulation, under resting conditions, as well as mediated by submaximal aerobic exercise sessions. Through a randomized, crossover, triple-blind, placebo-controlled clinical trial, 20 physically inactive hypertensive women will undergo an acute and 7-day trial, each with two intervention protocols: 1) placebo and 2) beetroot; in which will ingest beet juice with or without NO3 in its composition with a 7-day washout interval. On collection days, exercise will be performed on a treadmill for 40 minutes at a speed corresponding to 65-70% of VO2peak. The collection of variables (cardiovascular, autonomic, and blood samples for molecular analyses) of the study will take place at rest (120 minutes after ingestion of the intervention), during exercise (40 minutes), and in the effort recovery stage (during 65 minutes) based on previously validated protocols. The collections were arranged so that the measurement of one variable does not interfere with the other and that they have adequate intervals between them.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Hypertension, Postmenopausal; Menorrhagia, Cardiovascular Diseases

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Beet protocol
Arm Type
Experimental
Arm Description
Acute intervention: 1st day [140 ml - Beet It Juice, 800mg nitrate/day] Continued intervention: 2nd to 7th day [70 ml - Beet It Juice, 400mg nitrate/day] Exercise intervention [Treadmill - 40 minutes duration, 65% - 70% VO2 Peak]: Acute [Just on day] / Continued [First and latest day] Washout: 7 days
Arm Title
Placebo protocol
Arm Type
Placebo Comparator
Arm Description
Acute intervention (1st day): [140 ml - Beet It Juice, 0mg nitrate/day] Continued intervention (2nd to 7th day): [70 ml - Beet It Juice, 0mg nitrate/day] Exercise intervention [Treadmill - 40 minutes duration, 65% - 70% VO2 Peak]: Acute [Just on day] / Continued [First and latest day] Washout: 7 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Beetroot juice rich in nitrate
Intervention Description
On the first day, an acute test will be carried out with beet juice rich in nitrate, in which two units of juice will be provided, totaling 140 ml (800 mg of nitrate) for each protocol. That is, each participant will receive 2 units of juice bottles. From the second to the seventh day, participants will receive 6 units of vials of the juice corresponding to the first intervention on the first visit to the laboratory and will drink one vial a day for a week. Of the 8 units (100%), six bottles (75%) will be provided for the participants to take home. On the seventh day of the intervention, the participants will return to the laboratory for the consumption of the seventh and last bottle of juice. Between one protocol and another, a 7-day washout interval will be given for the purification of the compounds provided by the protocols.
Primary Outcome Measure Information:
Title
Values of systolic and diastolic blood pressure (mmHg)
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Values of heart rate variability (ms)
Time Frame
up to 2 years
Title
Values of heart rate (beats per minute)
Time Frame
up to 2 years
Title
Macrovascular function (Flow mediated dilatation%)
Time Frame
up to 2 years
Title
Plasmatic concentrations of nitrate and nitrite (mmol/L)
Time Frame
up to 2 years
Title
Blood concentration of Adiponectin (ug/mL)
Time Frame
up to 2 years
Title
Blood concentration of Hormone-sensitive lipase (mmol/min per kg DM)
Time Frame
up to 2 years
Title
Blood concentrations of C-reactive protein, Interleukin-6 and Interleukin-10 (ng/mL)
Time Frame
up to 2 years
Title
Blood concentrations of Epinephrine and Norepinephrine (pg/mL)
Time Frame
up to 2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with 50 to 65 old years; Physically inactive; Postmenopausal diagnosis (amenorrhea for 12 months or more); Arterial hypertension diagnosis (previously); Systolic blood pressure values >120mmHg up to 159mmHg and diastolic blood pressure values >80mmHg up to 99mmHg. Exclusion Criteria: Previous history of acute myocardial infarction and/or stroke; Allergy or intolerance to nitrate, gluten, or milk; Medications (proton pump inhibitors, beta-blockers, calcium channels antagonists).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cicero JR Benjamim, PhD Student
Phone
+5587988621194
Email
benjamim.nutricao@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Bueno Júnior, PhD
Organizational Affiliation
EEFERP/USP
Official's Role
Principal Investigator
Facility Information:
Facility Name
EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo
City
Ribeirão Preto
State/Province
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cicero Jonas R. Benjamim, PhD Student
Phone
87988621194
Email
benjamim.nutricao@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

NO3-rich Beet Juice and Exercise on Postmenopausal Women Cardiovascular Health

We'll reach out to this number within 24 hrs