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Completed

NCT Number: NCT04103736

The Effect of Dietary Nitrates on Physical Performance and Vascular Function in Chronic Kidney Disease

The purpose of this study is to examine the effect of acute ingestion of a concentrated beetroot juice supplement on vascular function and exercise capacity in patients with moderate to severe chronic kidney disease

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Key information

Conditions

Kidney Disease, Chronic Cardiovascular Diseases Chronic Disease Disease Attributes Endothelial Dysfunction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Kinesiology and Applied Physiology, University of Delaware

Newark, Delaware, 19713, United States

About this study

People with Chronic Kidney Disease (CKD) are at an increased risk of cardiovascular disease. Blood vessel dysfunction and exercise intolerance are common in CKD. Blood vessel dysfunction has been shown to predict future cardiovascular events and decreased physical activity can contribute to an increased risk of cardiovascular disease. Therefore, this study investigates if dietary nitrate from beetroot juice, which has been shown to improve blood vessel function and exercise capacity in other cardiovascular disease pathologies, could be effective at improving these measures in patients with CKD. In a controlled, double blinded trial, stage 3-5 CKD patients will be randomly assigned to receive either beetroot beverage or a placebo and then complete measures of blood vessel function and an exercise test.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stage 3-5 Chronic Kidney Disease

Exclusion criteria

  • History of cardiovascular disease
  • Current pregnancy
  • Uncontrolled hypertension
  • Uncontrolled hyperlipidemia
  • Current hormone replacement therapy
  • Current use of tobacco products
  • Current autoimmune disease
  • Current hyperkalemia
  • Diagnosis of a deep vein thrombosis (DVT) within the last 6 months

Treatment and study plan

Beet It Sport Shot

Dietary Supplement

Source of naturally occurring dietary nitrates

Nitrate-depleted placebo

Dietary Supplement

Placebo

Primary outcomes

  1. Microvascular Function, assessed by laser Doppler flowmetry coupled with intradermal microdialysis

    Time frame: 2.5 hours post ingestion of juice

    Nitric oxide mediated cutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with microdialysis

Secondary outcomes

  1. Endothelial function

    Time frame: 2.5 hours post ingestion of juice

    Conduit artery endothelial function assessed by brachial artery flow mediated dilation

  2. Blood pressure

    Time frame: Change from pre-ingestion baseline to 2.5 hours post ingestion of juice

    Blood pressure recorded by automatic blood pressure machine

  3. Arterial stiffness

    Time frame: 2.5 hours post ingestion of juice

    Carotid to femoral pulse wave velocity assessed by tonometry

  4. Pulse wave analysis

    Time frame: 2.5 hours post ingestion of juice

    Central blood pressure and augmentation index assessed by oscillometry and radial tonometry

  5. Peak aerobic capacity

    Time frame: 2.5 hours post ingestion of juice

    Peak oxygen uptake (VO2 peak) during incremental cycling exercise to exhaustion

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 25, 2019
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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