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

Sponsor

University of Delaware (Other)

Overall Status

Completed

CT.gov ID

NCT04103736

Collaborator

(none)

Enrollment

Location

Arms

18.9

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Disease, Chronic Endothelial Dysfunction	Dietary Supplement: Beet It Sport Shot Dietary Supplement: Nitrate-depleted placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Jun 29, 2017

Actual Study Completion Date :

Jun 29, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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