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| ID | Type | Description | Link |
|---|---|---|---|
| 88887.174291/2025-00 | Other Identifier | Coordenação de Aperfeiçoamento de Pessoal de NÃvel Superior - CAPES | |
| 7.865.400 | Other Identifier | Plataforma Brasil - CEP UNESP |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group (All Participants) | Experimental | All participants will undergo four experimental sessions in a randomized, counterbalanced order: 1) Resting with Placebo; 2) Resting with Nitrate Supplementation; 3) Aerobic Exercise with Placebo; and 4) Aerobic Exercise with Nitrate Supplementation. A washout period of at least 2 days will be respected between sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beetroot Extract (Nitrate-rich) | Dietary Supplement | Participants will ingest 2 capsules of a standardized beetroot extract (Berkeley Life Nitric Oxide Foundation). Each dose provides approximately 314 mg of dietary nitrate. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic and Diastolic Blood Pressure | Assessed using a validated automatic or semi-automatic device. Results measured in millimeters of mercury (mmHg). | Baseline (Rest), during intervention (at 10 and 20 minutes), immediately post-intervention (at 30 minutes), and 10 minutes post-intervention recovery. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Oxygen Saturation | Assessed via Near-Infrared Spectroscopy (NIRS) placed on the vastus lateralis muscle. Measured in percentage (%). | Continuously recorded during the 30-minute exercise session. |
| Oxidative Stress Markers (SOD, CAT, GPx, MDA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anderson S Zago, Professor | Contact | +55 14 98199-9293 | anderson.zago@unesp.br | |
| Lucas K Carvalho, Master's student | Contact | +55 14 99799-2971 | lk.carvalho@unesp.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| São Paulo State University (UNESP) | Recruiting | Bauru | São Paulo | 17011-041 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32772466 | Background | 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. | |
| 34284348 | Background | 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. |
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The data sharing policy has not yet been established. The research team will evaluate the feasibility and necessary ethical approvals for sharing individual participant data after the conclusion of the study and publication of the primary results.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| C092779 | RE1-silencing transcription factor |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Placebo | Dietary Supplement | 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. |
|
| Exercise | Behavioral | 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). |
|
| Rest (Control Condition) | Other | 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. |
|
Analysis of Superoxide Dismutase (SOD), Catalase (CAT), Glutathione Peroxidase (GPx), and Malondialdehyde (MDA) levels in blood plasma. Results measured in nanomoles per minute per gram of protein (nmol/min/g).
| Baseline (Pre-intervention) and immediately post-intervention (after exercise or rest). |
| 7154893 | Background | Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81. |
| 11153730 | Background | 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. |
| 30531488 | Background | 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. |
| 38403254 | Background | 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 Feb 23. |