Effect of Beet Juice Supplementation on Vascular and Inspiratory Muscle Function
Completed · Not applicable · Has a placebo group
Conditions studied: Coronary Artery Disease
In brief
Older adults with coronary artery disease (CAD) have impaired vascular and inspiratory muscle function. The overarching goal of this double-blind, randomized, crossover, placebo-controlled pilot trial was to inform the development of a fully powered trial to evaluate the effects of dietary nitrate supplementation in older adults with CAD. We aimed to address the following objectives: (a) assess the feasibility, tolerability, and safety of the study protocol; (b) gather preliminary evidence on the effects of nitrate-rich beetroot juice compared with nitrate-depleted beetroot juice (placebo), and estimate the effect sizes; and (c) determine if a full-scale definitive trial is justified.
Key facts
- Study ID
- NCT04920799
- Run by
- University of Florida
- People needed
- 8
- Starts
- 2021-11-12
- Expected to finish
- 2025-08-28
- Last updated by the study team
- 2026-05-14
Who can join
Age: 60 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults with coronary artery disease (CAD) based on an angiogram >50% stenosis in any major epicardial vessel or history of myocardial infarction or history of coronary revascularization.
- Considered to have stable CAD on optimal medical therapy
- 60 to 85 years of age
- Males and females (females must be postmenopausal either natural or surgical)
- Able to give consent
You may not qualify if…
- Unstable angina, recent myocardial infarction or heart failure within 6 months
- Coronary revascularization, including percutaneous coronary intervention and coronary artery bypass graft or thoracic surgery within 6 months.
- Stroke, obstructive pulmonary disease, hepatitis B, C, HIV, seizures, or other relevant ongoing or recurrent illness
- Individuals who have participated in respiratory training within the last 12 months or cardiac rehabilitation within the last 6 months
- Uncontrolled hypertension
- Use of tobacco products including smoking traditional or e-cigarettes
- Use of hormone replacement therapy in women or men (e.g., estrogen, progesterone or testosterone)
- Unwilling to stop using mouthwash at least 1 week before the start of the study and during study participation
- Unwilling to remain weight stable during study participation
Where it is running
- Integrative Cardiovascular Physiology Laboratory, University of Florida — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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