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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Kidney Disease, Chronic, Endothelial Dysfunction

Intervention / Treatment
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* Dietary Supplement: Beet It Sport Shot
* Dietary Supplement: Nitrate-depleted placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic kidney disease, dietary nitrates, beetroot juice, endothelium, vascular, cardiovascular disease, exercise capacity