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

Endothelial Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04103736
• Other study ID #: 706281-6
• Status: Completed
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: June 29, 2017

Study information

• Verified date: September 2019
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 29, 2017
• Est. primary completion date: June 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Kidney Disease, Chronic
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Beet It Sport Shot
Source of naturally occurring dietary nitrates
• Nitrate-depleted placebo
Placebo

Locations

Country	Name	City	State
United States	Department of Kinesiology and Applied Physiology, University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

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