Clinical trial NCT05384340: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Arterial Hypertension
Postmenopausal; Menorrhagia
Cardiovascular Diseases
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 20
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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).

Primary outcomes:
measure: Values of systolic and diastolic blood pressure (mmHg)
timeFrame: up to 2 years
Secondary outcomes:
measure: Values of heart rate variability (ms)
timeFrame: up to 2 years
measure: Values of heart rate (beats per minute)
timeFrame: up to 2 years
measure: Macrovascular function (Flow mediated dilatation%)
timeFrame: up to 2 years
measure: Plasmatic concentrations of nitrate and nitrite (mmol/L)
timeFrame: up to 2 years
measure: Blood concentration of Adiponectin (ug/mL)
timeFrame: up to 2 years
measure: Blood concentration of Hormone-sensitive lipase (mmol/min per kg DM)
timeFrame: up to 2 years
measure: Blood concentrations of C-reactive protein, Interleukin-6 and Interleukin-10 (ng/mL)
timeFrame: up to 2 years
measure: Blood concentrations of Epinephrine and Norepinephrine (pg/mL)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo
state: São Paulo
Study officials:
affiliation: EEFERP/USP
name: Carlos Bueno Júnior, PhD
role: PRINCIPAL_INVESTIGATOR
References: