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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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

20

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • イギリス
    • Oxfordshire
      • Oxford、Oxfordshire、イギリス、OX3 0BP
        • Clinical Physiology Laboratory, Oxford Brookes University
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：基礎科学
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
ダイエットサプリメント：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.
他の名前：
  • 硝酸塩が豊富なビーツジュース
ダイエットサプリメント：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.
他の名前：
  • Placebo beetroot juice
実験的：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.
ダイエットサプリメント：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.
他の名前：
  • 硝酸塩が豊富なビーツジュース
ダイエットサプリメント：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.
他の名前：
  • Placebo beetroot juice

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Systolic Blood Pressure During Post-Exercise Recovery
時間枠：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
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Diastolic Blood Pressure During Post-Exercise Recovery
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Oxford Brookes University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年4月2日

一次修了 (推定)

2026年7月31日

研究の完了 (推定)

2026年7月31日

試験登録日

最初に提出

2026年4月2日

QC基準を満たした最初の提出物

2026年4月28日

最初の投稿 (実際)

2026年5月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月1日

QC基準を満たした最後の更新が送信されました

2026年4月28日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • UREC-261968

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

At the time of submission for journal publication of results

IPD 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • CSR

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いいえ

米国FDA規制機器製品の研究

いいえ

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