Phase 2
N=26
Nitrites, Exercise, and Peripheral Arterial Disease
Peripheral Arterial Disease
Bottom Line
View on ClinicalTrials.gov: NCT01684930 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Change in Exercise Capacity: VO2peak (Maximal Oxygen Consumption) — 1.48; 0.23 ml/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training (Drug); Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Exercise Capacity: VO2peak (Maximal Oxygen Consumption) |
1.48; 0.23 | — |
| PRIMARY Change In Time To Exhaustion |
289.56; 254.92 | — |
| SECONDARY Change in Functional Ability |
172.89; 95 | — |
| SECONDARY Change In Claudication Onset Time |
199.22; 48.58 | — |
| SECONDARY Change In Vascular Function (BAFMD) |
-1.14; -0.19 | — |
| SECONDARY Change in Angiogenesis |
0.38; 0.26 | — |
Summary
The hypothesis of this proposal is that in subjects with PAD, regular consumption of a high nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of supervised exercise training at the limb ischemic threshold (SET) will produce a greater clinical benefit (increases in COT and PWT) than placebo plus supervised exercise at the limb ischemic threshold (PET).
Eligibility Criteria
Inclusion Criteria
- Peripheral Arterial Disease (ABI of less than 0.9)
- Intermittent Claudication for 3 or more months
Exclusion Criteria
- Individuals with known alcohol or drug abuse problems
- Individuals who have suffered a heart attack or stroke, or have changes on a resting ECG, in the last 3 months
- Those classified as American Heart Association Class D
- Gangrene, impending limb loss or osteomyelitis
- Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment
- Severe peripheral neuropathy
- Any condition other than PAD that limits walking
- Chest pain during treadmill exercise which appears before the onset of claudication, or >3mm ST depression during exercise
- Subjects taking nitrates or nitroglycerin products
- Must not be taking protein pump inhibitor medications
Data sourced from ClinicalTrials.gov (NCT01684930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.