Beetroot Juice
OtherTwo 70 ml beetroot juice drinks daily for 4 months.
NCT Number: NCT05624125
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.
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Not applicable
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two 70 ml beetroot juice drinks daily for 4 months.
Two 70 ml placebo drinks daily for 4 months.
Time frame: Baseline to four-month follow-up
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 2.5 hour follow-up
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 to four-month + 24 hour follow-up
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 follow-up
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
Change in WIQ distance score will be compared between those randomized to beetroot juice vs. those randomized to placebo
Time frame: 2.5 hour to four-month follow-up
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: 14 days after the end of the assigned study drink (intervention or placebo)
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: Baseline to four-month follow-up
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
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
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
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
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
Contact information is provided by the study sponsor or research team.
Kathryn Domanchuk, BS
CONTACT
Mary McDermott, MD
CONTACT
Northwestern University
Other
BEETroot Juice to Reverse Functional Impairment in PAD: The BEET PAD Trial
Acronym: BEET PAD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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