BEETroot Juice to Reverse Functional Impairment in PAD
ConditionPeripheral Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorNorthwestern University
About this trial
The BEET PAD Trial is a multi-centered double-blind randomized clinical trial designed to determine whether beetroot juice, compared to placebo, improves six-minute walk distance at four month follow-up in people with lower extremity peripheral artery disease (PAD). Investigators hypothesize that by simultaneously increasing lower extremity perfusion, gastrocnemius muscle mitochondrial activity, and myofiber health and regeneration, beetroot juice will significantly improve walking performance in people with PAD. The primary aim is to determine whether beetroot juice significantly improves six-minute walk distance at 4-month follow-up in people with PAD, compared to placebo. Preliminary evidence suggests that beetroot juice has both acute and chronic effects on walking performance in PAD. The primary outcome will measure the combined acute and chronic effect of beetroot juice (i.e. the maximal effect) on change in 6-minute walk at 4-month follow-up. In secondary aims, investigators will distinguish between acute and chronic effects of beetroot juice on six-minute walk and delineate biologic pathways by which beetroot juice improves walking performance in PAD, by measuring change in gastrocnemius muscle perfusion (MRI arterial spin labeling) and gastrocnemius muscle health. The trial will assess the durability of beetroot juice effects on six-minute walk. Nitrate in beetroot juice is metabolized to nitrite and subsequently to NO, attaining peak nitrite levels 2.5 hours after ingestion. The trial will determine whether a higher peak or a greater increase in plasma nitrite at 2.5 hours after beetroot juice consumption at baseline has a greater effect on six-minute walk at 4-month follow-up, compared to a lower peak or a smaller increase, respectively.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 50 and older
An ankle brachial index (ABI) <= 0.90 at baseline
Vascular lab evidence of PAD (such as a toe brachial pressure <= 0.70 or an ankle brachial index <=0.90), or angiographic evidence of PAD defined as at least 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 in either leg after the heel-rise test.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Beetroot juice
Other interventionTwo 70 ml beetroot juice drinks daily for 4 months.
Placebo
Other interventionTwo 70 ml placebo drinks daily for 4 months.
Treatment groups
210 Participants
are divided into 2 treatment groupsGroup A: Beetroot juiceActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Four-month change in six-minute walk distance
Change in six-minute walk distance at four-month follow-up will be compared between those randomized to beetroot juice vs. those randomized to placebo
Time frame
Baseline to four-month follow-upSecondary outcomes
1
2.5 hour change in six-minute walk distance (acute effect)
Change in six-minute walk distance 2.5 hours after drinking the first study beverage (acute effect) will be compared between those randomized to beetroot juice vs. those randomized to placebo
Time frame
Baseline 2.5 hour follow-up2
Four-month + 24 hour change in six-minute walk distance (chronic effect)
Change in six-minute walk distance at four-month follow-up, 24 hours after drinking study beverage (chronic effect) will be compared between those randomized to beetroot juice vs. those randomized to placebo
Time frame
Baseline to four-month + 24 hour follow-up3
Four-month change in calf muscle perfusion
Change in calf muscle perfusion will be compared between those randomized to beetroot juice vs. those randomized to placebo
Time frame
Baseline to four-month follow-up4
Four-month change in Walking Impairment Questionnaire (WIQ) distance score
Change in WIQ distance score will be compared between those randomized to beetroot juice vs. those randomized to placebo
Time frame
Baseline to four-month follow-upOther outcomes
1
Durability of effect on six-minute walk distance
Change in six-minute walk distance at 14 days after the final drink that the participant was randomized to will be compared between those randomized to beetroot juice vs. those randomized to placebo
Time frame
14 days after the end of the assigned study drink (intervention or placebo)2
Four-month change in Walking Impairment Questionnaire (WIQ) speed and stair climbing scores
Change in WIQ speed and stair climbing scores at four-month follow-up will be compared between those randomized to beetroot juice vs. those randomized to placebo
Time frame
Baseline to four-month follow-up3
Four-month change in Short-Form 36 Physical Function questionnaire score
Change in Short-Form 36 Physical Function questionnaire score at four-month follow-up will be compared between those randomized to beetroot juice vs. those randomized to placebo
Time frame
Baseline to four-month follow-up4
Four-month change in short physical performance battery (SPPB) score
Change in SPPB score at four-month follow-up will be compared between those randomized to beetroot juice vs. those randomized to placebo
Time frame
Baseline to four-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Northwestern University
Lead sponsor
University of Virginia
Collaborator
University of Chicago
Collaborator
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov