Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-27 @ 5:04 PM
Study NCT ID:
NCT02223403
Status:
COMPLETED
Last Update Posted:
2014-08-22
First Post:
2014-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Nitrate-rich Beetroot Juice on Exercise Performance in Heart Failure Patients
Sponsor:
Brooke Army Medical Center
Organization:
Study Overview
Official Title:
Single Dose of Nitrate-rich Beetroot Juice Does Not Improve Steady State Oxygen Consumption or Six-minute Walk Distance in Patients With Systolic Heart Failure.
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nitrate-rich beetroot juice supplementation has demonstrated reduced oxygen consumption and submaximal exercise performance in healthy adults. Investigation for similar effects in patients with heart failure has not previously been conducted.
This was a randomized, double-blind, placebo controlled trial. Following ingestion of the active agent or placebo, subjects with systolic heart failure underwent submaximal steady state exercise with gas exchange analysis followed thirty minutes later by a six minute walk test. Second testing sessions were performed ten days.
There were no significant differences in the treatment and placebo arms in average oxygen consumption or six minute walk distance.
In conclusion, in patients with heart failure who have ingested a single dose of nitrate-rich beetroot juice concentrate, there is no significant difference with regard to oxygen consumption during submaximal steady state exercise or six minute walk testing distance.
Further study is warranted to determine the true efficacy of nitrate consumption in this population with adjustments in acute or chronic dosing, exercise duration, or intensity.
This was a randomized, double-blind, placebo controlled trial. Following ingestion of the active agent or placebo, subjects with systolic heart failure underwent submaximal steady state exercise with gas exchange analysis followed thirty minutes later by a six minute walk test. Second testing sessions were performed ten days.
There were no significant differences in the treatment and placebo arms in average oxygen consumption or six minute walk distance.
In conclusion, in patients with heart failure who have ingested a single dose of nitrate-rich beetroot juice concentrate, there is no significant difference with regard to oxygen consumption during submaximal steady state exercise or six minute walk testing distance.
Further study is warranted to determine the true efficacy of nitrate consumption in this population with adjustments in acute or chronic dosing, exercise duration, or intensity.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: