Effect of Beet Juice Supplementation on Vascular and Inspiratory Muscle Function

NCT ID: NCT04920799

Last Updated: 2025-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-12

Study Completion Date

2026-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Nitrate rich beetroot juice

Group Type ACTIVE_COMPARATOR

Nitrate rich beetroot juice

Intervention Type 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 depleted beetroot juice

Group Type PLACEBO_COMPARATOR

Nitrate depleted beetroot juice

Intervention Type 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.

Interventions

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Nitrate rich beetroot juice

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.

Intervention Type DIETARY_SUPPLEMENT

Nitrate depleted beetroot juice

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Integrative Cardiovascular Physiology Laboratory, University of Florida

Gainesville, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Demetra Christou, PhD

Role: CONTACT

352-294-1746

Stephanie Lapierre, MS

Role: CONTACT

Facility Contacts

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Demetra Christou, PhD

Role: primary

352-294-1746

Other Identifiers

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IRB202100040

Identifier Type: -

Identifier Source: org_study_id

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