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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 29, 2017

Detailed Description

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.

Interventions

  • Dietary Supplement: Beet It Sport Shot
    • Source of naturally occurring dietary nitrates
  • Dietary Supplement: Nitrate-depleted placebo
    • Placebo

Arms, Groups and Cohorts

  • Experimental: Beet Juice Supplement
    • A single, acute dose of Beet It Sport Shot containing ~12.6mmol naturally occurring dietary nitrates.
  • Placebo Comparator: Placebo juice
    • A single, acute dose of nitrate-depleted Beet It Sport Shot

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Endothelial function
    • Time Frame: 2.5 hours post ingestion of juice
    • Conduit artery endothelial function assessed by brachial artery flow mediated dilation
  • 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
  • Arterial stiffness
    • Time Frame: 2.5 hours post ingestion of juice
    • Carotid to femoral pulse wave velocity assessed by tonometry
  • Pulse wave analysis
    • Time Frame: 2.5 hours post ingestion of juice
    • Central blood pressure and augmentation index assessed by oscillometry and radial tonometry
  • Peak aerobic capacity
    • Time Frame: 2.5 hours post ingestion of juice
    • Peak oxygen uptake (VO2 peak) during incremental cycling exercise to exhaustion

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Delaware
  • Provider of Information About this Clinical Study
    • Sponsor

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