NO3-rich Beet Juice and Exercise on Cardiovascular Health in Postmenopausal Women
Study Details
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, 25 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| 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.
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| 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.
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Outcome Measures
Primary Outcome Measures
- Values of heart rate variability (ms) [up to 2 years]
- Values of systolic and diastolic blood pressure (mmHg) [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]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Womens with 50 to 70 old years;
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Physically inactive;
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Postmenopausal diagnosis (amenorrhea for 12 months or more);
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Systolic blood pressure values >140mmHg up to 159mmHg or diastolic blood pressure values >90mmHg up to 99mmHg.
Exclusion Criteria:
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Previous history of acute myocardial infarction and/or stroke;
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Allergy or intolerance to nitrate, gluten, or milk;
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Medications (proton pump inhibitors, beta-blockers, calcium channels antagonists).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo | Ribeirão Preto | São Paulo | Brazil |
Sponsors and Collaborators
- University of Sao Paulo
Investigators
- Principal Investigator: Carlos Bueno Júnior, PhD, EEFERP/USP
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BeetMPH5070