Phase
Condition
Atherosclerosis
Claudication
Thrombosis
Treatment
Beetroot juice
Placebo
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 50 and older
Presence of peripheral artery disease, defined as:
An ankle brachial index (ABI) <= 0.90 at baseline
Vascular lab evidence of PAD (such as a toe brachial pressure <= 0.70 or anankle brachial index <=0.90), or angiographic evidence of PAD defined as atleast 70% stenosis of an artery supplying the lower extremities.
An ABI of >0.90 and <=1.00 who experience a 20% or greater drop in ABI ineither leg after the heel-rise test.
Exclusion
Exclusion Criteria:
Above- or below-knee amputation
Critical limb ischemia defined as an ABI <0.40 with symptoms of rest pain
Wheelchair confinement or requiring a walker to ambulate
Walking is limited by a symptom other than PAD
Current foot ulcer on bottom of foot
Failure to successfully complete the study run-in
Planned major surgery, coronary or leg revascularization during the next five months
Major surgery, coronary or leg revascularization or major cardiovascular event inthe previous three months
Major medical illness including lung disease requiring oxygen, Parkinson's disease,a life-threatening illness with life expectancy less than six months, or cancerrequiring treatment in the previous two years. [NOTE: potential participants maystill qualify if they have had treatment for an early stage cancer in the past twoyears and the prognosis is excellent. Participants who require oxygen only at nightmay still qualify.]
Mini-Mental Status Examination (MMSE) score < 23
Allergy to beetroot juice
Currently consuming beetroot juice, oral nitrate or nitrite, or a beetrootsupplement and/or unwilling to avoid beetroot juice during the study. Participantswill be asked to discontinue these items for 30 days before baseline testing andthroughout the clinical trial. If the potential participant is unwilling to refrainfrom taking these items, they will not be eligible for the clinical trial.
Currently consuming one cup or more of beets daily. Participants will be asked todiscontinue beet ingestion of one cup or more of beets for 30 days before baselinetesting and throughout the clinical trial. If the potential participant is unwillingto refrain from daily beet consumption of one cup or more for 30 days before thetrial and during the trial, they will not be eligible for the clinical trial.
Non-English speaking
Participation in or completion of a clinical trial in the previous three months. [NOTE: after completing a stem cell or gene therapy intervention, participants willbecome eligible after the final study follow-up visit of the stem cell or genetherapy study so long as at least six months have passed since the finalintervention administration. After completing a supplement or drug therapy (otherthan stem cell or gene therapy), participants will be eligible after the final studyfollow-up visit as long as at least three months have passed since the finalintervention of the trial.]
Visual impairment that limits walking ability.
Six-minute walk distance of <500 feet or >1600 feet. Investigator discretion will beused to decide whether participants who walk greater than 1600 feet are eligible.
Baseline blood pressure <100/45.
Participation in a supervised treadmill exercise program in previous three months.
Using an antibacterial mouthwash (such as Cepacol) or a mouthwash containingchlorhexidine and unwilling to discontinue.
In addition to the above criteria, investigator discretion will be used to determineif the trial is unsafe or not a good fit for the potential participant.
Study Design
Connect with a study center
Northwestern University Feinberg School of Medicine
Chicago, Illinois 60611
United StatesActive - Recruiting
University of Chicago
Chicago, Illinois 60637
United StatesActive - Recruiting
University of Minnesota
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
University of Virginia
Charlottesville, Virginia 22903
United StatesSite Not Available
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