Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AG073257 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Virginia | OTHER |
| University of Chicago | OTHER |
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beetroot juice | Active Comparator | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beetroot juice | Other | Two 70 ml beetroot juice drinks daily for 4 months. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to four-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline 2.5 hour follow-up |
| Four-month + 24 hour change in six-minute walk distance (chronic effect) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 14 days after the end of the assigned study drink (intervention or placebo) |
Inclusion Criteria:
Age 50 and older
Presence of peripheral artery disease, defined as:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary McDermott, MD | Contact | 312-503-6419 | mdm608@northwestern.edu | |
| Kathryn Domanchuk, BS | Contact | 312-503-6438 | k-domanchuk@northwestern.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Recruiting | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42035974 | Derived | McDermott MM, Cetlin MD, Domanchuk KJ, Xu S, Whipple MO, Polonsky T, Criqui MH, Guralnik JM, Tian L, Zhao L, Ho KJ, Greenland P, Treat-Jacobson D. Community-based recruitment with ankle brachial index testing to identify peripheral artery disease participants for randomized clinical trials. Am Heart J. 2026 Apr 24;300:107450. doi: 10.1016/j.ahj.2026.107450. Online ahead of print. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Other |
Two 70 ml placebo drinks daily for 4 months. |
|
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 |
| 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 | 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 | 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 | 2.5 hour to four-month follow-up |
| 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 |
| 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 | 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 | 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 | 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 | Baseline to four-month follow-up |
| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
|
| University of Virginia | Active, not recruiting | Charlottesville | Virginia | 22903 | United States |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |