Community-based recruitment with ankle brachial index testing to identify peripheral artery disease participants for randomized clinical trials.
Mary M McDermott, Madeline D Cetlin, Kathryn J Domanchuk...
https://pubmed.ncbi.nlm.nih.gov/42035974/Actively Recruiting
Led by Northwestern University · Updated on 2026-04-15
210
Participants Needed
4
Research Sites
26 weeks
Total Duration
Researchers are evaluating the effects of beetroot juice on walking ability in people aged 50 and older with peripheral artery disease PAD, a condition that affects blood flow to the legs. This multi-center, double-blind, randomized clinical trial aims to see if beetroot juice can improve the distance participants can walk in six minutes after four months compared to a placebo. The study also explores how beetroot juice affects muscle blood flow, muscle health, and regeneration, as well as the relationship between nitrate metabolism and walking performance. Participants receive either two 70 ml drinks daily for four months containing beetroot juice with nitrate or a placebo drink that looks similar but has the nitrate removed. Each active drink provides 400 mg of nitrate, totaling 800 mg daily. The study measures both the immediate effect of beetroot juice 2.5 hours after consumption and the longer-term effects after four months. The placebo group receives a nitrate-free beetroot juice drink to compare results. During the trial, participants undergo tests including a six-minute walk test at baseline, 2.5 hours, and four months to measure walking distance changes. Additional assessments measure calf muscle blood flow using MRI, muscle health, and questionnaire scores related to walking ability. Researchers will monitor nitrate levels in the blood to understand their impact. Participants are followed for at least four months, with strict eligibility criteria and health monitoring to ensure safety and study integrity.
CONDITIONS
BEETroot Juice to Reverse Functional Impairment in PAD
M
Mary McDermott, MD
K
Kathryn Domanchuk, BS
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Northwestern University
Lead Sponsor
University of Virginia
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Beetroot juice (twice daily for 4 months) | Placebo drink (twice daily for 4 months) |
|---|---|---|
| What it is | Beetroot juice drink taken twice daily for 4 months by people with PAD | A matching placebo drink taken twice daily for 4 months |
| Role in trial | Investigational intervention | Randomized comparator arm |
| Primary use | Studied to improve walking performance (6‑minute walk) in PAD | Comparator for evaluating beetroot juice effect on walking |
| How it is given or performed | Two 70 ml drinks per day for 4 months | Two 70 ml matched placebo drinks per day for 4 months |
| Evidence status | Preliminary studies show acute or chronic beetroot juice may improve walking ability or vascular responses in PAD, but high‑quality evidence remains limited | Placebo serves as inactive comparator; no efficacy |
| Important risks | Safety not established in PAD population; potential risks of dietary nitrate in PAD not well characterized | Placebo control; safety profile not applicable |
| Important limitations | Effect on walking may depend on peak nitrite levels and mechanisms under investigation; results pending | As inactive comparator, no direct therapeutic benefit |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 months
Participants receive two 70 ml drinks daily of either beetroot juice or placebo for 4 months to evaluate effects on functional impairment in PAD.
Baseline visit and follow-up visits during treatment
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Mary M McDermott, Madeline D Cetlin, Kathryn J Domanchuk...
https://pubmed.ncbi.nlm.nih.gov/42035974/Northwestern University
Lead Sponsor
University of Virginia
Collaborating Sponsor