Effect of Beet Juice Supplementation on Vascular and Inspiratory Muscle Function

NCT04920799 | Active Not Recruiting

• 1 other identifier: IRB202100040
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• Change in endothelial function

  Endothelial function will be determined using brachial artery flow-mediated dilation via high resolution duplex ultrasonography. Reactive hyperemia will be produced by inflating a forearm cuff to \~250 mmHg for 5 minutes followed by rapid deflation.

  Baseline up to following 2 weeks of experimental condition

• Change in inspiratory muscle function

  Inspiratory muscle function including strength, power and endurance will be assessed using the POWERbreathe KH2 device

  Baseline up to following 2 weeks of experimental condition

Secondary Outcomes (4)

• Change in microvascular function

  Baseline up to following 2 weeks of experimental condition

• Change in central arterial stiffness

  Baseline up to following 2 weeks of experimental condition

• Change in central arterial hemodynamics

  Baseline up to following 2 weeks of experimental condition

• Change in functional capacity

  Baseline up to following 2 weeks of experimental condition

Study Arms (2)

Nitrate rich beetroot juice

ACTIVE COMPARATOR

Dietary Supplement: Nitrate rich beetroot juice

Nitrate depleted beetroot juice

PLACEBO COMPARATOR

Dietary Supplement: Nitrate depleted beetroot juice

Interventions

Nitrate depleted beetroot juice DIETARY_SUPPLEMENT

Participants will drink nitrate depleted beetroot juice (2.4 floz ; Beet It placebo concentrated beetroot shot; James White Drink, ltd) twice daily for two weeks.

Nitrate depleted beetroot juice

Nitrate rich beetroot juice DIETARY_SUPPLEMENT

Participants will drink nitrate rich beetroot juice (2.4 floz ; Beet It Sport Nitrate 400 concentrated beetroot shot; James White Drink, ltd) twice daily for two weeks.

Nitrate rich beetroot juice

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Integrative Cardiovascular Physiology Laboratory, University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 10, 2021
• Study Start: November 12, 2021
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: April 15, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)