Effect of Beet Juice Supplementation on Vascular and Inspiratory Muscle Function

N/AActive Not RecruitingNCT04920799

University of Florida8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Coronary Artery Disease

Interventions

Eligibility

Sex: ALLMin age: 60 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.