Recruiting

Beetroot Juice

Sponsor:

University of Virginia

Code:

NCT06948201

Conditions

Coronary Microvascular Dysfunction (CMD)

Angina Patients With Non-obstructive Coronary Artery Disease

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

70mL Nitrate Rich Beetroot Juice followed by placebo (Nitrate depleted beetroot juice)

Placebo (70 mL Nitrate depleted beetroot juice) followed by 70mL Nitrate Rich Beetroot Juice

Study Details

Brief summary:

The purpose of this study is to see if inorganic nitrate in the form of beetroot juice helps blood flow and physical fitness in women with ANOCA and CMD. The main questions it aims to answer are:

AIM 1: Test the hypothesis that fourteen days of nitrate rich beetroot juice will increase cardiac perfusion and improve quality of life compared to placebo.

AIM 2: Test the hypothesis that fourteen days of nitrate rich beetroot juice will increase physical fitness and reduce angina and dyspnea symptoms compared to placebo.

Exploratory AIM 3: Test the hypothesis that fourteen days of nitrate rich beetroot juice will improve vascular health and function.

Participants will:

  • Take study beverage for 4 weeks total.
  • Stress Cardiac magnetic resonance imaging and 12 lead electrocardiograms
  • Complete questionnaires
  • Cycling exercise test
  • Non invasive vascular testing
  • Blood draws

Conditions

Coronary Microvascular Dysfunction (CMD)

Angina Patients With Non-obstructive Coronary Artery Disease

Study ID

NCT06948201

Start date

Jan 2, 2026

Status verified date

Sep, 2026

Completion date

Nov 17, 2026

Anticipated

Primary completion date

Nov 17, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥18 years.
  • Female sex.
  • Willing and able to provide written informed consent.
  • Signs and symptoms of suspected ischemia prompted referral for further evaluation by cardiac catheterization or CCTA within two years of consent.
  • No evidence of obstructive epicardial CAD (stenosis >50%) of a major epicardial vessel or an FFR ≤0.80 by invasive catheterization or CCTA. Patients who have not undergone cardiac catheterization of CT angiogram within the last 2 years for chest pain can be scheduled for a screening CT angiogram of the coronary arteries to confirm eligibility.
  • Impaired coronary flow reserve (cut-off values depending on methodology use between ≤2.0 and ≤2.5 by stress testing PET/CMR or Invasive assessment) or Abnormal index of coronary microcirculatory resistance (e.g., IMR > 25)
  • SGLT2i Naïve

Exclusion Criteria:

  • History of non-ischemic cardiomyopathy LVEF <40% or hypertrophic cardiomyopathy.
  • History of congestive heart failure, severe pulmonary disease, liver disease
  • History of acute coronary syndrome (ACS) within previous 30 days
  • Stroke within the last 180 days or intracranial hemorrhage at any time.
  • Severe valvular disease
  • Life expectancy <3 years, due to non-cardiovascular comorbidity.
  • Pregnancy or women who are breast-feeding
  • Type 1 diabetes mellitus
  • Symptomatic hypotension or systolic BP<95 mmHg on 2 consecutive measurements
  • Active malignancy requiring treatment at the time of visit
  • Severe (eGFR <30 mL/min/1.73 m2 by CKD-EPI), unstable, or rapidly progressing renal disease at the time of randomization
  • History of recurrent UTI/bladder/kidney infections
  • Asthma with ongoing wheezing
  • Known or suspected bronchoconstrictive or bronchospastic lung disease (ARDS, emphysema)
  • Greater than first degree heart block
  • Implanted cardiac device
  • Profound sinus bradycardia (heart rates<40 beats per minute)
  • Atrial fibrillation or supraventricular arrhythmias at time of imaging
  • Known intolerance of nitrates (other than hypotension)
  • History of reaction to iodinated contrast agents
  • Any orthopedic, neurological, or other condition that prevents participant from exercising
  • Individuals currently taking nitroglycerine (or inorganic nitrates), PDE-5 inhibitors (ex: Cialis, Viagra), and xanthine oxidase inhibitors (ex: Allopurinol)
  • Smokers within the last 5 years
  • Prisoners
  • Cognitively impaired individuals
  • Non-English Speaking

Study Design

Enrollment

8 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Beetroot juice followed by placebo

70mL Nitrate Rich Beetroot Juice for 14 days followed by placebo (70mL nitrate depleted beetroot juice) for 14 days

other: Placebo followed by Beetroot juice

Placebo (70 mL nitrate depleted beetroot juice) for 14 days followed by Nitrate rich Beetroot juice for 14 days

Interventions

70mL Nitrate Rich Beetroot Juice followed by placebo (Nitrate depleted beetroot juice)

70mL Nitrate Rich Beetroot Juice for 14 days followed by placebo (Nitrate depleted beetroot juice) for 14 days

Placebo (70 mL Nitrate depleted beetroot juice) followed by 70mL Nitrate Rich Beetroot Juice

Placebo (70 mL Nitrate depleted beetroot juice) for 14 days followed by 70mL Nitrate Rich Beetroot Juice for 14 days

Primary outcome measure

  • Change in Coronary Flow Reserve [ Time Frame: From enrollment to day 14 ]

Central Contacts and Locations

Central contacts

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Principal Investigator:

Patricia Rodriguez-Lozano, MD

More Information

Sponsor

University of Virginia

Last update posted

Nov 9, 2026

Last verified

Sep, 2026

Keywords

  • angina
  • ANOCA
  • Non-obstructive Coronary Artery Disease
  • CMD
  • Non-Obstructive CAD
  • Chest Pain in Women

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-11-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.