NCT01919177

Effect of Inorganic Nitrates (Beetroot Juice) on Arterial Hemodynamics and Exercise Capacity

Effect of Inorganic Nitrates on Arterial Hemodynamics and Exercise Capacity

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Corporal Michael J. Crescenz VA Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective is to test the hypothesis that inorganic nitrate supplementation will: (1) Improve exercise efficiency and performance; (2) Enhance the systemic vasodilator reserve during exercise and specifically, the vasodilator response in exercising muscle; (3) Reduce arterial wave reflections and arterial load; (4) Improve skeletal muscle mitochondrial function in subjects with heart failure with preserved ejection fraction.

Detailed description

This represents a series of double-blind, controlled pilot randomized studies in which the effects of nitrate-rich beetroot juice and nitrate-depleted beetroot juice will be assessed in patients with heart failure and preserved ejection fraction (n=20). A total of 20 subjects will be enrolled over a 1.5 year period and randomized in a cross-over design to a single dose of nitrate-rich beetroot juice and nitrate-depleted beetroot juice. The order of the interventions will be randomized; thus, all subjects will receive the nitrate-rich and nitrate-depleted juice, with a 4-7 day washout period in-between studies.

Conditions

• Heart Failure With Normal Ejection Fraction

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nitrate rich beetroot juice	Subjects will receive 140 mL of Nitrate-rich concentrated beetroot juice.
DIETARY_SUPPLEMENT	Nitrate depleted beetroot juice	Subjects will receive 140 mL of nitrate-depleted beetroot juice.

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-09-01
• Completion: 2014-11-01
• First posted: 2013-08-08
• Last updated: 2015-04-28

Locations

1 site across 1 country: United States