An interventional study of Beetroot juice and Placebo in Peripheral Artery Disease, sponsored by Northwestern University. Recruiting at 4 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's planned enrollment of 210 is above the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Presence of peripheral artery disease, defined as:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The beetroot juice intervention comes in a single 70 ml drink and is manufactured by James White Drinks. Each drink contains beetroot juice and 2% lemon juice, made from concentrates. Each serving of 70 mL of beetroot juice contains 400 mgs (6.45 millimoles) of nitrate and will be taken twice daily for a total daily dose of 800 mgs (12.90 millimoles) of nitrate.
Other: Beetroot juice
The placebo comes in a single 70 ml drink and is manufactured by James White Drinks. The placebo contains beetroot juice and 2% lemon juice, made from concentrates, and is filtered to remove nitrate.
Other: Placebo
Two 70 ml beetroot juice drinks daily for 4 months.
Two 70 ml placebo drinks daily for 4 months.
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-up
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-up
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-up
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-up
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-up
Four-month change in six-minute walk distance among participants randomized to beetroot juice
Among those randomized to beetroot juice, investigators will determine whether those who attain a higher immediate peak or a greater increase in plasma nitrate levels at 2.5 hours after the first dose of beetroot juice at baseline will have a greater six-minute walk improvement at 4-month follow-up, compared to those with a lower peak or a smaller increase in nitrite, respectively
Time frame: 2.5 hour to four-month follow-up
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)
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-up
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-up
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-up
Four-month change in nitrate and nitrite abundance in muscle
Change in nitrate and nitrate abundance in muscle in participants who undergo gastrocnemius (calf) muscle biopsy will be compared between those randomized to beetroot juice vs. those randomized to placebo
Time frame: Baseline to four-month follow-up
Four-month change in mitochondrial oxygen consumption
Change in mitochondrial oxygen consumption in participants who undergo gastrocnemius (calf) muscle biopsy will be compared between those randomized to beetroot juice vs. those randomized to placebo
Time frame: Baseline to four-month follow-up
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