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

Not Applicable

Completed

• Conditions: Kidney Disease, Chronic; Endothelial Dysfunction
• Interventions: Dietary Supplement: Nitrate-depleted placebo; Dietary Supplement: Beet It Sport Shot

• Registration Number: NCT04103736
• Lead Sponsor: University of Delaware

Brief Summary

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

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 Timeline

• Study Start: 2015-12-01
• Primary Completion: 2017-06-29
• Study Completion: 2017-06-29
• Study First Submitted: 2019-04-29
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-24
• Last Update Submitted: 2019-09-24
• Study First Posted: 2019-09-25
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo juice	Nitrate-depleted placebo	A single, acute dose of nitrate-depleted Beet It Sport Shot
Beet Juice Supplement	Beet It Sport Shot	A single, acute dose of Beet It Sport Shot containing \~12.6mmol naturally occurring dietary nitrates.

Primary Outcome Measures

Name	Time	Method
Microvascular Function, assessed by laser Doppler flowmetry coupled with intradermal microdialysis	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 Outcome Measures

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

Trial Locations

Locations (1)

Department of Kinesiology and Applied Physiology, University of Delaware; 🇺🇸 Newark, Delaware, United States