NO3-rich Beet Juice and Exercise on Postmenopausal Women Cardiovascular Health
- Conditions
- Postmenopausal; MenorrhagiaCardiovascular DiseasesArterial Hypertension
- Interventions
- Dietary Supplement: Beetroot juice rich in nitrate
- Registration Number
- NCT05384340
- Lead Sponsor
- University of Sao Paulo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 20
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Beet protocol Beetroot juice rich in nitrate 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 Placebo protocol Beetroot juice rich in nitrate 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
- Primary Outcome Measures
Name Time Method Values of systolic and diastolic blood pressure (mmHg) up to 2 years
- Secondary Outcome Measures
Name Time Method Blood concentrations of C-reactive protein, Interleukin-6 and Interleukin-10 (ng/mL) up to 2 years Blood concentration of Hormone-sensitive lipase (mmol/min per kg DM) up to 2 years Values of heart rate (beats per minute) up to 2 years Macrovascular function (Flow mediated dilatation%) up to 2 years Values of heart rate variability (ms) up to 2 years Blood concentration of Adiponectin (ug/mL) up to 2 years Blood concentrations of Epinephrine and Norepinephrine (pg/mL) up to 2 years Plasmatic concentrations of nitrate and nitrite (mmol/L) up to 2 years
Trial Locations
- Locations (1)
EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo
🇧🇷Ribeirão Preto, São Paulo, Brazil