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

NCT ID: NCT04103736

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-01
• Study Completion Date: 2017-06-29

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.

Conditions

Kidney Disease, Chronic; Endothelial Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Beet Juice Supplement

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

Group Type: EXPERIMENTAL

Beet It Sport Shot

Intervention Type: DIETARY_SUPPLEMENT

Source of naturally occurring dietary nitrates

Placebo juice

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

Group Type: PLACEBO_COMPARATOR

Nitrate-depleted placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Interventions

Beet It Sport Shot

Source of naturally occurring dietary nitrates

Intervention Type: DIETARY_SUPPLEMENT

Nitrate-depleted placebo

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Delaware

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Kinesiology and Applied Physiology, University of Delaware

Newark, Delaware, United States

Countries

United States

Other Identifiers

706281-6

Identifier Type: -

Identifier Source: org_study_id