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Effect of Beet Juice Supplementation on Vascular and Inspiratory Muscle Function

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University of Florida

Status

Enrolling

Conditions

Coronary Artery Disease

Treatments

Dietary Supplement: Nitrate rich beetroot juice
Dietary Supplement: Nitrate depleted beetroot juice

Study type

Interventional

Funder types

Other

Identifiers

NCT04920799
IRB202100040

Details and patient eligibility

About

Older adults with coronary artery disease (CAD) have impaired vascular and inspiratory muscle function. The objective of this study is to examine the effect of beet juice supplementation on vascular and inspiratory muscle function in older adults with CAD.

Enrollment

24 estimated patients

Sex

All

Ages

60 to 85 years old

Volunteers

No Healthy Volunteers

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
  • Men and women (women must be postmenopausal either natural or surgical)
  • Able to give consent

Exclusion criteria

  • Ejection fraction <50%, unstable angina, recent myocardial infarction 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 on-going or recurrent illness
  • Individuals that 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)
  • Regular aerobic exercise training
  • 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

24 participants in 2 patient groups, including a placebo group

Nitrate rich beetroot juice
Active Comparator group
Treatment:
Dietary Supplement: Nitrate rich beetroot juice
Nitrate depleted beetroot juice
Placebo Comparator group
Treatment:
Dietary Supplement: Nitrate depleted beetroot juice

Trial contacts and locations

1

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Central trial contact

Demetra Christou, PhD; Stephanie Lapierre, MS

Data sourced from clinicaltrials.gov

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