- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01684930
Nitrites, Exercise, and Peripheral Arterial Disease (NO-PAD)
August 26, 2017 updated by: Jason Allen, Ph.D., Duke University
Increased Plasma Nitrite, Tissue Oxygenation and Functional Changes in PAD
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).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke Diet & Fitness Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BR Juice (Beet-It Stamina Shot) and Exercise Training
Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4).
It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4).
All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
|
The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks.
This supplement will be used in conjunction with supervised exercise training.
Other Names:
|
Placebo Comparator: BR Juice Placebo and Exercise Training
Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4).
It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4).
All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
|
The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed.
It is also bottled and supplied by James White Drinks.
This placebo supplement will be used in conjunction with supervised exercise training.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Exercise Capacity: VO2peak (Maximal Oxygen Consumption)
Time Frame: Baseline and 16 Weeks
|
Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption, claudication onset time and peak walking time.
|
Baseline and 16 Weeks
|
Change In Time To Exhaustion
Time Frame: Baseline and 16 weeks
|
Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of total time to exhaustion.
|
Baseline and 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Functional Ability
Time Frame: Baseline and 16 Weeks
|
Six-Minute Walk test.
This test simple and practical assessment of functional capacity.
The test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes.
The test is self-paced and assesses the submaximal level of functional capacity.
The subjects choose their own intensity and are allowed to stop and rest if necessary during the test.
|
Baseline and 16 Weeks
|
Change In Claudication Onset Time
Time Frame: Baseline and 16 weeks
|
Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of claudication onset time.
|
Baseline and 16 weeks
|
Change In Vascular Function (BAFMD)
Time Frame: Baseline and 16 weeks
|
Vascular Function is measured as Brachial artery flow-mediated dilation (BAFMD).
BAFMD is a measure of change in artery diameter after a stimulus .
|
Baseline and 16 weeks
|
Change in Angiogenesis
Time Frame: Baseline and 16 weeks
|
Gastrocnemious muscle biopsy will be performed to measure the number of capillaries per fibre as a marker of change in angiogenesis between groups
|
Baseline and 16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jason Allen, PhD, Duke University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
September 11, 2012
First Submitted That Met QC Criteria
September 12, 2012
First Posted (Estimate)
September 13, 2012
Study Record Updates
Last Update Posted (Actual)
August 29, 2017
Last Update Submitted That Met QC Criteria
August 26, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00031918
- 1R21HL111972-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral Arterial Disease
-
University of NebraskaNot yet recruitingPeripheral Arterial Disease | Peripheral Vascular Diseases | Peripheral Arterial Occlusive Disease | Peripheral Artery DiseaseUnited States
-
CID S.p.A.Meditrial Europe Ltd.Not yet recruitingPeripheral Arterial Occlusive Disease | Peripheral Artery DiseaseItaly
-
Marissa JarosinskiRecruitingPeripheral Arterial Occlusive Disease | Peripheral Vascular Disease | Peripheral Artery Disease | Clopidogrel, Poor Metabolism of | Artery DiseaseUnited States
-
Stanford UniversityTerminatedPAD - Peripheral Arterial Disease | PVD- Peripheral Vascular DiseaseUnited States
-
Vascuros Medical Pte LtdNovella ClinicalUnknownPeripheral Arterial Occlusive Disease | Peripheral Vascular Disease | Peripheral Artery DiseaseSingapore, Belgium, Germany
-
Western Vascular Institute, IrelandRecruitingPeripheral Arterial Occlusive DiseaseIreland
-
Jena University HospitalAngioDroid s.r.l., Bologna (Italy)CompletedPeripheral Arterial Occlusive DiseaseGermany
-
Seoul National University HospitalAstellas Pharma Korea, Inc.CompletedPeripheral Arterial Occlusive DiseaseKorea, Republic of
-
Heidelberg UniversityTerminatedPeripheral Arterial Occlusive DiseaseGermany
-
Johann Wolfgang Goethe University HospitalSuspendedPeripheral Arterial Occlusive DiseaseGermany
Clinical Trials on Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedPeripheral Arterial Disease | Type II Diabetes MellitusUnited States
-
Brooke Army Medical CenterCompletedSystolic Heart Failure
-
Penn State UniversityCompletedPostmenopausal WomenUnited States
-
Penn State UniversityCompleted
-
Corporal Michael J. Crescenz VA Medical CenterCompletedHeart Failure With Normal Ejection FractionUnited States
-
University Hospital, GhentResearch Foundation FlandersRecruiting
-
Wake Forest University Health SciencesCompleted
-
David N. Proctor, PhDMilton S. Hershey Medical Center; Wake Forest University Health SciencesActive, not recruitingPeripheral Arterial DiseaseUnited States
-
Royal Surrey County Hospital NHS Foundation TrustUnknownColorectal Cancer
-
Western Sydney Local Health DistrictWestmead Institute for Medical ResearchCompletedHypertension | Endothelial Dysfunction | Autosomal Dominant Polycystic KidneyAustralia