NCT05384340

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

Status unknown NA Last updated 12 January 2023

What this trial tests

NA trial testing Beetroot juice rich in nitrate in Arterial Hypertension in 20 participants. Status unknown.

Timeline

31 May 2022

Primary endpoint
30 June 2024

30 July 2024

Quick facts

Lead sponsor	University of Sao Paulo
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	health services research
Enrollment	20
Start date	31 May 2022
Primary completion	30 June 2024
Estimated completion	30 July 2024
Sites	1 location across Brazil

Drugs / interventions tested

• Beetroot juice rich in nitrate

Conditions studied

• Arterial Hypertension — all drugs for Arterial Hypertension →
• Postmenopausal; Menorrhagia — all drugs for Postmenopausal; Menorrhagia →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

University of Sao Paulo

Who can join

Adults 50 to 65, female only, with Arterial Hypertension or Postmenopausal; Menorrhagia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Benjamim CJR, da Silva LSL, Sousa YBA, Rodrigues GDS, et al · · 2024 · cited 17× · PMID 38092272 · DOI 10.1016/j.freeradbiomed.2023.11.039
2. 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.
   Benjamim CJR, Sousa YBA, Porto AA, de Moraes Pontes YM, et al · · 2023 · cited 11× · PMID 36750904 · DOI 10.1186/s13063-023-07117-2
3. Dietary Inorganic Nitrate Accelerates Cardiac Parasympathetic Recovery After Exercise in Older Women with Hypertension: A Secondary Analysis of a Randomised Crossover Study.
   Benjamim J, Lopes da Silva LS, Alves Sousa YB, Gonçalves LDS, et al · · 2025 · PMID 41441031 · DOI 10.3390/metabo15120789