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

University of Sao Paulo

Status: Enrolling

Conditions: Arterial Hypertension; Postmenopausal; Menorrhagia; Cardiovascular Diseases

Treatments: Dietary Supplement: Beetroot juice rich in nitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT05384340

BeetMPH5070

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: No 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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Beet protocol

Experimental group

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

Treatment:

Dietary Supplement: Beetroot juice rich in nitrate

Placebo protocol

Placebo Comparator group

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

Treatment:

Dietary Supplement: Beetroot juice rich in nitrate