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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beet protocol | Experimental | 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 | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beetroot juice rich in nitrate | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Values of systolic and diastolic blood pressure (mmHg) | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Values of heart rate variability (ms) | up to 2 years | |
| Values of heart rate (beats per minute) | up to 2 years | |
| Macrovascular function (Flow mediated dilatation%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cicero JR Benjamim, PhD Student | Contact | +5587988621194 | benjamim.nutricao@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Carlos Bueno Júnior, PhD | EEFERP/USP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EEFERP - USP / Laboratório de Fisiologia do ExercÃcio e Metabolismo | Recruiting | Ribeirão Preto | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38092272 | Derived | Benjamim CJR, da Silva LSL, Sousa YBA, Rodrigues GDS, Pontes YMM, Rebelo MA, Goncalves LDS, Tavares SS, Guimaraes CS, da Silva Sobrinho AC, Tanus-Santos JE, Gualano B, Bueno Junior CR. Acute and short-term beetroot juice nitrate-rich ingestion enhances cardiovascular responses following aerobic exercise in postmenopausal women with arterial hypertension: A triple-blinded randomized controlled trial. Free Radic Biol Med. 2024 Feb 1;211:12-23. doi: 10.1016/j.freeradbiomed.2023.11.039. Epub 2023 Dec 11. | |
| 36750904 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D008595 | Menorrhagia |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
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| ID | Term |
|---|---|
| D009566 | Nitrates |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D017942 |
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|
| up to 2 years |
| Plasmatic concentrations of nitrate and nitrite (mmol/L) | 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 |
| Derived |
| Benjamim CJR, Sousa YBA, Porto AA, de Moraes Pontes YM, Tavares SS, da Silva Rodrigues G, da Silva LSL, da Silva Goncalves L, Guimaraes CS, Rebelo MA, da Silva Sobrinho AC, Tanus-Santos JE, Valenti VE, Gualano B, Bueno Junior CR. Nitrate-rich beet juice intake on cardiovascular performance in response to exercise in postmenopausal women with arterial hypertension: study protocol for a randomized controlled trial. Trials. 2023 Feb 7;24(1):94. doi: 10.1186/s13063-023-07117-2. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
| Nitric Acid |
| D017672 | Nitrogen Compounds |
| D009930 | Organic Chemicals |