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

NCT04103736 | Completed

• 1 other identifier: 706281-6
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Kidney Disease, Chronic; Endothelial Dysfunction

Keywords

chronic kidney disease; dietary nitrates; beetroot juice; endothelium, vascular; cardiovascular disease; exercise capacity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Endothelial function

  2.5 hours post ingestion of juice

• Blood pressure

  Change from pre-ingestion baseline to 2.5 hours post ingestion of juice

• Arterial stiffness

  2.5 hours post ingestion of juice

• Pulse wave analysis

  2.5 hours post ingestion of juice

• Peak aerobic capacity

  2.5 hours post ingestion of juice

Study Arms (2)

Beet Juice Supplement

EXPERIMENTAL

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

Dietary Supplement: Beet It Sport Shot

Placebo juice

PLACEBO COMPARATOR

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

Dietary Supplement: Nitrate-depleted placebo

Interventions

Beet It Sport Shot DIETARY_SUPPLEMENT

Source of naturally occurring dietary nitrates

Beet Juice Supplement

Nitrate-depleted placebo DIETARY_SUPPLEMENT

Placebo

Placebo juice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage 3-5 Chronic Kidney Disease

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

Department of Kinesiology and Applied Physiology, University of Delaware

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: September 25, 2019
• Study Start: December 1, 2015
• Primary Completion: June 29, 2017
• Study Completion: June 29, 2017
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)