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

Primary Purpose

Kidney Disease, Chronic, Endothelial Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Beet It Sport Shot
Nitrate-depleted placebo
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Kidney Disease, Chronic focused on measuring chronic kidney disease, dietary nitrates, beetroot juice, endothelium, vascular, cardiovascular disease, exercise capacity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Kinesiology and Applied Physiology, University of Delaware

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Beet Juice Supplement

Placebo juice

Arm Description

A single, acute dose of Beet It Sport Shot containing ~12.6mmol naturally occurring dietary nitrates.

A single, acute dose of nitrate-depleted Beet It Sport Shot

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Endothelial function
Conduit artery endothelial function assessed by brachial artery flow mediated dilation
Blood pressure
Blood pressure recorded by automatic blood pressure machine
Arterial stiffness
Carotid to femoral pulse wave velocity assessed by tonometry
Pulse wave analysis
Central blood pressure and augmentation index assessed by oscillometry and radial tonometry
Peak aerobic capacity
Peak oxygen uptake (VO2 peak) during incremental cycling exercise to exhaustion

Full Information

First Posted
April 29, 2019
Last Updated
September 24, 2019
Sponsor
University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT04103736
Brief Title
The Effect of Dietary Nitrates on Physical Performance and Vascular Function in Chronic Kidney Disease
Official Title
The Effect of Dietary Nitrates on Physical Performance and Vascular Function in Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
June 29, 2017 (Actual)
Study Completion Date
June 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Delaware

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Disease, Chronic, Endothelial Dysfunction
Keywords
chronic kidney disease, dietary nitrates, beetroot juice, endothelium, vascular, cardiovascular disease, exercise capacity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Beet Juice Supplement
Arm Type
Experimental
Arm Description
A single, acute dose of Beet It Sport Shot containing ~12.6mmol naturally occurring dietary nitrates.
Arm Title
Placebo juice
Arm Type
Placebo Comparator
Arm Description
A single, acute dose of nitrate-depleted Beet It Sport Shot
Intervention Type
Dietary Supplement
Intervention Name(s)
Beet It Sport Shot
Intervention Description
Source of naturally occurring dietary nitrates
Intervention Type
Dietary Supplement
Intervention Name(s)
Nitrate-depleted placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Microvascular Function, assessed by laser Doppler flowmetry coupled with intradermal microdialysis
Description
Nitric oxide mediated cutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with microdialysis
Time Frame
2.5 hours post ingestion of juice
Secondary Outcome Measure Information:
Title
Endothelial function
Description
Conduit artery endothelial function assessed by brachial artery flow mediated dilation
Time Frame
2.5 hours post ingestion of juice
Title
Blood pressure
Description
Blood pressure recorded by automatic blood pressure machine
Time Frame
Change from pre-ingestion baseline to 2.5 hours post ingestion of juice
Title
Arterial stiffness
Description
Carotid to femoral pulse wave velocity assessed by tonometry
Time Frame
2.5 hours post ingestion of juice
Title
Pulse wave analysis
Description
Central blood pressure and augmentation index assessed by oscillometry and radial tonometry
Time Frame
2.5 hours post ingestion of juice
Title
Peak aerobic capacity
Description
Peak oxygen uptake (VO2 peak) during incremental cycling exercise to exhaustion
Time Frame
2.5 hours post ingestion of juice

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Kinesiology and Applied Physiology, University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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