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Effect of Beetroot Juice on Cardiovascular and Autonomic Responses to Exercise in Adults With Type 2 Diabetes (DiaBEET)

2026年4月28日 更新者：Dr. Shakeeb H Moosavi、Oxford Brookes University

Effect of Beetroot Juice on Cardiovascular and Autonomic Responses During and After Exercise in Adults With Type 2 Diabetes

This study will investigate whether a single dose of beetroot juice can improve cardiovascular responses and recovery after exercise in adults with Type 2 Diabetes.

Type 2 Diabetes is associated with higher blood pressure, impaired blood vessel function, and reduced autonomic control of the heart, all of which increase cardiovascular risk and may affect how the body responds to and recovers from physical activity. Beetroot juice is naturally rich in dietary nitrate, which is converted in the body into nitric oxide, a molecule that helps blood vessels relax and improve blood flow. While these effects have been demonstrated in healthy individuals, less is known about their impact in people with Type 2 Diabetes.

In this study, approximately 16 to 20 adults aged 40 to 65 years with Type 2 Diabetes will take part. After an online screening and consent process, eligible participants will attend two laboratory visits at Oxford Brookes University. In a randomised, double-blind, placebo-controlled crossover design, participants will receive beetroot juice during one visit and a nitrate-depleted placebo during the other visit.

During each visit, participants will undergo physiological measurements, including blood pressure, heart rate, oxygen saturation, and capillary blood glucose. Participants will then complete a short session of supervised, light-to-moderate cycling exercise. Measurements will continue during the recovery period to assess how quickly the cardiovascular system returns to resting levels.

The main outcomes are systolic blood pressure and heart rate variability during recovery, which reflect cardiovascular regulation and autonomic function. Secondary outcomes include diastolic blood pressure, heart rate, blood glucose, and markers related to nitric oxide availability.

This study may help determine whether a simple, dietary-based intervention such as beetroot juice can support cardiovascular function and improve recovery after exercise in people living with Type 2 Diabetes.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Type 2 diabetes mellitus (T2DM) is characterised by endothelial dysfunction, elevated blood pressure and impaired autonomic regulation, all of which contribute to increased cardiovascular risk. In particular, reduced cardiovagal modulation and delayed recovery of cardiovascular parameters following exercise are associated with adverse clinical outcomes. These disturbances are closely linked to reduced nitric oxide bioavailability.

Dietary inorganic nitrate, abundant in beetroot juice, is converted via the entero-salivary nitrate-nitrite-nitric oxide pathway into nitric oxide, promoting vasodilation, improved endothelial function and reductions in blood pressure. Acute supplementation with nitrate-rich beetroot juice has been shown to enhance nitric oxide bioavailability within approximately 2 to 3 hours after ingestion, making it suitable for investigating short-term physiological responses. However, evidence in individuals with T2DM remains limited, particularly regarding post-exercise autonomic recovery.

This study is designed as a randomised, double-blind, placebo-controlled crossover trial to evaluate the acute effects of nitrate-rich beetroot juice on cardiovascular and autonomic responses to exercise in adults with T2DM not treated with insulin. Each participant will complete two experimental conditions, receiving nitrate-rich beetroot juice and a nitrate-depleted placebo in random order, separated by an adequate washout period. Randomisation will be performed using a computer-generated sequence by an independent researcher, and both participants and investigators will remain blinded to allocation.

All procedures will be conducted in a controlled laboratory environment under supervision by trained research staff. Continuous physiological monitoring will be performed to capture cardiovascular responses at rest, during exercise and throughout the recovery period. The exercise protocol consists of a standardised, light-to-moderate intensity cycling task designed to provide a consistent physiological stimulus while minimising risk.

The primary focus of the study is on post-exercise recovery, with particular emphasis on heart rate variability as an index of autonomic (vagal) modulation and systolic blood pressure as a marker of haemodynamic regulation. The crossover design allows each participant to serve as their own control, improving statistical efficiency and reducing inter-individual variability.

Safety procedures are integrated throughout the protocol, including pre-participation screening, standardised preparation requirements and continuous monitoring during all experimental phases. The study is conducted as a low-risk laboratory protocol, with predefined procedures for the management of any adverse or unexpected physiological responses.

The findings of this study are expected to contribute to the understanding of whether acute dietary nitrate supplementation can improve cardiovascular regulation and autonomic recovery following exercise in individuals with T2DM, providing mechanistic insight and potential implications for non-pharmacological strategies to support cardiovascular health in this population.

研究类型

介入性

注册 (估计的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 英国
    • Oxfordshire
      • Oxford、Oxfordshire、英国、OX3 0BP
        • Clinical Physiology Laboratory, Oxford Brookes University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Clinically diagnosed Type 2 Diabetes Mellitus
  • Aged 40 to 65 years
  • Not treated with insulin
  • Stable diabetes medication regimen for at least 3 months
  • Able to understand the study information and provide informed consent
  • Able to safely perform light-to-moderate cycling exercise

Exclusion Criteria:

  • Current or recent use of insulin
  • Use of organic nitrates (e.g., glyceryl trinitrate) or phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil)
  • Use of systemic antibiotics within the specified preparation period or regular use of antiseptic/antibacterial mouthwash during study participation
  • Use of supplements known to interfere with nitric oxide metabolism within the defined preparation period
  • Unstable or clinically significant cardiovascular disease
  • Uncontrolled hypertension or any condition that makes exercise unsafe
  • Chronic kidney disease, history of kidney stones, or other relevant renal conditions
  • Neurological, musculoskeletal or systemic disorders that impair safe participation
  • Known or suspected allergy or intolerance to beetroot, lemon or any component of the study products
  • Pregnancy or breastfeeding
  • Inability to comply with study preparation requirements

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：基础科学
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Beetroot Juice Then Placebo
Participants receive nitrate-rich beetroot juice during the first visit and a nitrate-depleted placebo during the second visit, with a washout period of at least 48 hours between visits.
膳食补充剂：Beetroot juice
A single dose of approximately 70 mL of nitrate-rich beetroot juice providing approximately 400 mg of inorganic nitrate will be administered. The product consists of concentrated beetroot juice with a small amount of lemon juice and is consumed prior to exercise testing. The timing of ingestion is standardized to allow peak nitrate-nitrite-nitric oxide conversion within approximately 2 to 3 hours. This intervention is intended to increase nitric oxide bioavailability and assess its acute effects on cardiovascular and autonomic responses.
其他名称：
  • 富含硝酸盐的甜菜根汁
膳食补充剂：Nitrate-depleted Beetroot Juice Placebo
A nitrate-depleted beetroot juice placebo matched for appearance, taste and packaging will be administered in a single dose of approximately 70 mL. The placebo is identical to the active intervention in all aspects except for nitrate content. It is consumed under the same standardized conditions and timing as the active intervention to maintain blinding and allow controlled comparison of physiological responses.
其他名称：
  • Placebo beetroot juice
实验性的：Placebo Then Beetroot Juice
Participants receive a nitrate-depleted placebo during the first visit and nitrate-rich beetroot juice during the second visit, with a washout period of at least 48 hours between visits.
膳食补充剂：Beetroot juice
A single dose of approximately 70 mL of nitrate-rich beetroot juice providing approximately 400 mg of inorganic nitrate will be administered. The product consists of concentrated beetroot juice with a small amount of lemon juice and is consumed prior to exercise testing. The timing of ingestion is standardized to allow peak nitrate-nitrite-nitric oxide conversion within approximately 2 to 3 hours. This intervention is intended to increase nitric oxide bioavailability and assess its acute effects on cardiovascular and autonomic responses.
其他名称：
  • 富含硝酸盐的甜菜根汁
膳食补充剂：Nitrate-depleted Beetroot Juice Placebo
A nitrate-depleted beetroot juice placebo matched for appearance, taste and packaging will be administered in a single dose of approximately 70 mL. The placebo is identical to the active intervention in all aspects except for nitrate content. It is consumed under the same standardized conditions and timing as the active intervention to maintain blinding and allow controlled comparison of physiological responses.
其他名称：
  • Placebo beetroot juice

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Systolic Blood Pressure During Post-Exercise Recovery
大体时间：During post-exercise recovery mean value at 0-10 minutes, 10-20 minutes, 20-30 minutes, and 50-60 minutes.
Systolic blood pressure will be measured continuously during the post-exercise recovery period following submaximal cycling using beat-to-beat monitoring. This measure will be used to assess haemodynamic regulation after exercise under each intervention condition.
During post-exercise recovery mean value at 0-10 minutes, 10-20 minutes, 20-30 minutes, and 50-60 minutes.
Heart Rate Variability (RMSSD) During Post-Exercise Recovery
大体时间：During post-exercise recovery at 0-10 minutes, 10-20 minutes, 20-30 minutes, and 50-60 minutes.
Heart rate variability, expressed as the root mean square of successive differences (RMSSD), will be derived from continuous electrocardiogram recordings during the post-exercise recovery period following submaximal cycling. This measure will be used to assess autonomic (vagal) recovery after exercise under each intervention condition.
During post-exercise recovery at 0-10 minutes, 10-20 minutes, 20-30 minutes, and 50-60 minutes.

次要结果测量

结果测量
措施说明
大体时间
Diastolic Blood Pressure During Post-Exercise Recovery
大体时间：During post-exercise recovery mean value at 0-10 minutes, 10-20 minutes, 20-30 minutes, and 50-60 minutes.
Diastolic blood pressure will be measured continuously during the post-exercise recovery period following submaximal cycling using beat-to-beat monitoring. This measure will be used to assess haemodynamic responses and vascular regulation after exercise under each intervention condition.
During post-exercise recovery mean value at 0-10 minutes, 10-20 minutes, 20-30 minutes, and 50-60 minutes.
Heart Rate During Post-Exercise and Recovery
大体时间：During post-exercise recovery mean value at 0-10 minutes, 10-20 minutes, 20-30 minutes, and 50-60 minutes.
Heart rate will be measured continuously during submaximal cycling exercise and throughout the post-exercise recovery period using electrocardiogram monitoring. This measure will be used to assess cardiovascular response to exercise and the rate of recovery toward resting levels under each intervention condition.
During post-exercise recovery mean value at 0-10 minutes, 10-20 minutes, 20-30 minutes, and 50-60 minutes.
Capillary Blood Glucose Response
大体时间：Pre-ingestion; 15, 30, 45, 60, 90, and 120 minutes post-ingestion; and 5 and 60 minutes post-exercise
Capillary blood glucose will be measured using finger-prick sampling at predefined time points, including pre-ingestion, 15, 30, 45, 60, 90 and 120 minutes post-ingestion, and at 5 and 60 minutes post-exercise. These measurements will be used to assess glycaemic response to the intervention and exercise under each experimental condition.
Pre-ingestion; 15, 30, 45, 60, 90, and 120 minutes post-ingestion; and 5 and 60 minutes post-exercise
Salivary Nitric Oxide-Related Response
大体时间：Baseline, 1 hour post-ingestion, and 2 hours post-ingestion.
Salivary nitric oxide-related response will be assessed using test strips that estimate nitrate and nitrite concentrations in saliva. Measurements will be performed at baseline, 1 hour post-ingestion, and 2 hours post-ingestion. This measure will be used as an indicator of nitric oxide bioavailability following dietary nitrate supplementation under each experimental condition.
Baseline, 1 hour post-ingestion, and 2 hours post-ingestion.
Perceived Exertion During Exercise
大体时间：On both test days (beetroot juice and placebo days) perceived exertion will be recorded every minute during the submaximal cycling ramp test from timepoint M3 (2 hours post-ingestion) to timepoint M4 (peak exercise)
Perceived exertion will be assessed during the submaximal cycling ramp test using the Borg Rating of Perceived Exertion (6-20 scale). The scale ranges from 6 (no exertion) to 20 (maximal exertion), with higher scores indicating greater perceived effort. Ratings will be collected every minute during the exercise test and at peak exercise under each intervention condition.
On both test days (beetroot juice and placebo days) perceived exertion will be recorded every minute during the submaximal cycling ramp test from timepoint M3 (2 hours post-ingestion) to timepoint M4 (peak exercise)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Oxford Brookes University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年4月2日

初级完成 (估计的)

2026年7月31日

研究完成 (估计的)

2026年7月31日

研究注册日期

首次提交

2026年4月2日

首先提交符合 QC 标准的

2026年4月28日

首次发布 (实际的)

2026年5月1日

研究记录更新

最后更新发布 (实际的)

2026年5月1日

上次提交的符合 QC 标准的更新

2026年4月28日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • UREC-261968

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The de-identified IPD used in the results publication will be made available on the Oxford Brookes University Research And Digital Assets Repository (RADAR)

IPD 共享时间框架

At the time of submission for journal publication of results

IPD 共享访问标准

RADAR shares the intellectual product of Oxford Brookes University freely and openly, either with the staff and students of Oxford Brookes or with the general public and global academic community.

IPD 共享支持信息类型

  • 研究方案
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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