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

Study Overview

• Status: Completed
• Conditions: Endothelial Dysfunction; Kidney Disease, Chronic
• Intervention / Treatment: Dietary supplement: Beet It Sport Shot; Dietary supplement: Nitrate-depleted placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19713
      • Department of Kinesiology and Applied Physiology, University of Delaware

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Beet Juice Supplement; A single, acute dose of Beet It Sport Shot containing ~12.6mmol naturally occurring dietary nitrates.	Dietary supplement: Beet It Sport Shot; Source of naturally occurring dietary nitrates
Placebo Comparator: Placebo juice; A single, acute dose of nitrate-depleted Beet It Sport Shot	Dietary supplement: Nitrate-depleted placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microvascular Function, assessed by laser Doppler flowmetry coupled with intradermal microdialysis	Nitric oxide mediated cutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with microdialysis	2.5 hours post ingestion of juice

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial function	Conduit artery endothelial function assessed by brachial artery flow mediated dilation	2.5 hours post ingestion of juice
Blood pressure	Blood pressure recorded by automatic blood pressure machine	Change from pre-ingestion baseline to 2.5 hours post ingestion of juice
Arterial stiffness	Carotid to femoral pulse wave velocity assessed by tonometry	2.5 hours post ingestion of juice
Pulse wave analysis	Central blood pressure and augmentation index assessed by oscillometry and radial tonometry	2.5 hours post ingestion of juice
Peak aerobic capacity	Peak oxygen uptake (VO2 peak) during incremental cycling exercise to exhaustion	2.5 hours post ingestion of juice

Collaborators and Investigators

• Sponsor: University of Delaware

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): June 29, 2017
• Study Completion (Actual): June 29, 2017

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: exercise capacity; cardiovascular disease; chronic kidney disease; beetroot juice; endothelium, vascular; dietary nitrates
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 706281-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No