Effects of Beetroot Extract on Blood Pressure and Exercise in Hypertensive Older Women

Официальное название

Acute Effects of Beetroot Extract Supplementation on Blood Pressure, Oxidative Stress, and Muscle Oxygen Saturation in Hypertensive Older Women Submitted to an Aerobic Exercise Session

Обзор

The goal of this clinical trial is to learn about the acute effects of beetroot extract in older women with high blood pressure. The main questions it aims to answer are: Does beetroot extract affect blood pressure during exercise? Does it change oxygen levels in the muscles? Participants will take a beetroot supplement and perform an aerobic exercise session to check how their bodies respond.

Подробное описание

Note: Although registered as Single Group/Open Label for data entry purposes, this study is strictly double-blind and randomized regarding the order of interventions (crossover design).

Hypertension is a major risk factor for cardiovascular disease in older adults. Dietary nitrate, found in beetroot extract, has been shown to improve vascular health and exercise tolerance. However, its specific effects on older women with hypertension during exercise require further investigation.

This clinical trial aims to analyze the acute impact of beetroot extract supplementation on cardiovascular and metabolic parameters. Specifically, the study will measure blood pressure responses, oxidative stress markers, and muscle oxygen saturation (assessed via NIRS) in hypertensive older women submitted to a single session of aerobic exercise. The goal is to determine if nitrate supplementation can attenuate the cardiovascular stress of exercise and improve muscle oxygenation in this population.

Вмешательства

• Пищевая добавка Beetroot Extract (Nitrate-rich)
  Participants will ingest 2 capsules of a standardized beetroot extract (Berkeley Life Nitric Oxide Foundation). Each dose provides approximately 314 mg of dietary nitrate.
• Пищевая добавка Placebo
  Capsules identical in appearance, color, and size to the experimental supplement, but containing an inert substance (starch). This intervention is used to maintain the double-blind design of the study.
• Поведенческое Exercise
  Participants will perform a single aerobic exercise session on a treadmill. The protocol consists of a 7-minute warm-up followed by 30 minutes of continuous exercise at an intensity corresponding to 60-80% of maximum heart rate (HRmax), estimated using Tanaka's formula (208 - 0.7 \* age). Rate of Perceived Exertion (RPE) will be monitored periodically using the Borg scale (6-20).
• Другое Rest (Control Condition)
  Participants will remain seated for 30 minutes (matching the exercise session duration). During this time, a researcher will administer a Food Frequency Questionnaire (FFQ) in an interview format. This activity serves to assess dietary habits and simulates a routine, low-exertion daily activity (similar to a conversation), acting as a time-matched control for the exercise session.

Первичные конечные точки

• Systolic and Diastolic Blood Pressure [Срок оценки: Baseline (Rest), during intervention (at 10 and 20 minutes), immediately post-intervention (at 30 minutes), and 10 minutes post-intervention recovery.]

Вторичные конечные точки (2)

• Muscle Oxygen Saturation [Срок оценки: Continuously recorded during the 30-minute exercise session.]
• Oxidative Stress Markers (SOD, CAT, GPx, MDA) [Срок оценки: Baseline (Pre-intervention) and immediately post-intervention (after exercise or rest).]

Критерии участия

Критерии включения

• Female sex: Older women aged between 60 and 70 years.
• Physical capability: Absence of health conditions that could compromise performance in the required physical exercise tests.

Критерии исключения

• Smoking: Current smokers.
• Alcohol use: History of alcohol abuse or excessive alcohol consumption.
• Cardiovascular Disease: Diagnosis of cardiovascular diseases (other than the primary condition of hypertension).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Бразилия · 1 центр

• São Paulo State University (UNESP) — Bauru

Публикации

• Guimaraes DA, Batista RIM, Tanus-Santos JE. Nitrate and nitrite-based therapy to attenuate cardiovascular remodelling in arterial hypertension. Basic Clin Pharmacol Toxicol. 2021 Jan;128(1):9-17. doi: 10.1111/bcpt.13474. Epub 2020 Aug 28. PMID 32772466
• van der Avoort CMT, van Loon LJC, Verdijk LB, Poyck PPC, Thijssen DTJ, Hopman MTE. Acute Effects of Dietary Nitrate on Exercise Tolerance, Muscle Oxygenation, and Cardiovascular Function in Patients With Peripheral Arterial Disease. Int J Sport Nutr Exerc Metab. 2021 Sep 1;31(5):385-396. doi: 10.1123/ijsnem.2021-0054. Epub 2021 Jul 20. PMID 34284348
• Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81. PMID 7154893
• Tanaka H, Monahan KD, Seals DR. Age-predicted maximal heart rate revisited. J Am Coll Cardiol. 2001 Jan;37(1):153-6. doi: 10.1016/s0735-1097(00)01054-8. PMID 11153730
• Caldwell JT, Sutterfield SL, Post HK, Craig JC, Baumfalk DR, Copp SW, Ade CJ. Impact of Acute Dietary Nitrate Supplementation during Exercise in Hypertensive Women. Med Sci Sports Exerc. 2019 May;51(5):1014-1021. doi: 10.1249/MSS.0000000000001857. PMID 30531488
• Benjamim CJR, Lopes da Silva LS, Valenti VE, Goncalves LS, Porto AA, Tasinafo Junior MF, Walhin JP, Garner DM, Gualano B, Bueno Junior CR. Effects of dietary inorganic nitrate on blood pressure during and post-exercise recovery: A systematic review and meta-analysis of randomized placebo-controlled trials. Free Radic Biol Med. 2024 Mar;215:25-36. doi: 10.1016/j.freeradbiomed.2024.02.011. Epub 2024 PMID 38403254

Идентификаторы

NCT: NCT07444138 · 7.865.400 · 88887.174291/2025-00 · 7.865.400

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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