Effect of Beet Juice Supplementation on Vascular and Inspiratory Muscle Function (NCT04920799) | Clinical Trial Compass
CompletedNot Applicable
Effect of Beet Juice Supplementation on Vascular and Inspiratory Muscle Function
United States8 participantsStarted 2021-11-12
Plain-language summary
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.
Who can participate
Age range
60 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in endothelial function
Timeframe: Baseline up to following 2 weeks of experimental condition
2
Change in inspiratory muscle function
Timeframe: Baseline up to following 2 weeks of experimental condition