drugset / Trial / NCT01684930
Nitrites, Exercise, and Peripheral Arterial Disease
Phase 2
Completed
32 enrolled
Duke University
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupTriple-blindTreatment
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).
Timeline
- Start
- 2012-06
- Primary completion
- 2014-11
- Completion
- 2014-11
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
paper the primary outcomes of COT, PWT, and 6MW PMID 28974486 ↗
paper too underpowered-EX+BR, n=11; EX+PL, n=13-to determine between-group differences in the primary outcomes of COT, PWT, and 6MW PMID 28974486 ↗
Publications
- Woessner M, VanBruggen MD, Pieper CF, Sloane R, Kraus WE, Gow AJ, Allen JD. Beet the Best? Circ Res. 2018 Aug 31;123(6):654-659. doi: 10.1161/CIRCRESAHA.118.313131.
- Woessner MN, VanBruggen MD, Pieper CF, O'Reilly EK, Kraus WE, Allen JD. Combined Dietary Nitrate and Exercise Intervention in Peripheral Artery Disease: Protocol Rationale and Design. JMIR Res Protoc. 2017 Oct 3;6(10):e139. doi: 10.2196/resprot.7596.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Beetroot Juice | Other / unclassified | 70 ml | Oral |