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

Nitrate-rich Beet Juice Intake and Aerobic Exercise on Cardiovascular Health of Postmenopausal Women With Arterial Hypertension

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Arterial Hypertension; Postmenopausal; Menorrhagia
• Intervention / Treatment: Dietary supplement: Beetroot juice rich in nitrate

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cicero JR Benjamim, PhD Student; Phone Number: +5587988621194; Email: benjamim.nutricao@gmail.com

Study Locations

• Brazil
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil
      • Recruiting
      • EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo
      • Contact: Cicero Jonas R. Benjamim, PhD Student; Phone Number: 87988621194; Email: benjamim.nutricao@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Beet protocol; 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	Dietary supplement: Beetroot juice rich in nitrate; 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.
Placebo Comparator: Placebo protocol; 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	Dietary supplement: Beetroot juice rich in nitrate; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Values of systolic and diastolic blood pressure (mmHg)	up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Values of heart rate variability (ms)	up to 2 years
Values of heart rate (beats per minute)	up to 2 years
Plasmatic concentrations of nitrate and nitrite (mmol/L)	up to 2 years
Macrovascular function (Flow mediated dilatation%)	up to 2 years
Blood concentration of Adiponectin (ug/mL)	up to 2 years
Blood concentration of Hormone-sensitive lipase (mmol/min per kg DM)	up to 2 years
Blood concentrations of C-reactive protein, Interleukin-6 and Interleukin-10 (ng/mL)	up to 2 years
Blood concentrations of Epinephrine and Norepinephrine (pg/mL)	up to 2 years

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Carlos Bueno Júnior, PhD, EEFERP/USP

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): July 30, 2024

Study Registration Dates

• First Submitted: April 17, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Vascular Diseases; Uterine Diseases; Hemorrhage; Menstruation Disturbances; Uterine Hemorrhage; Hypertension; Cardiovascular Diseases; Menorrhagia
• Other Study ID Numbers: BeetMPH5070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No