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Nitrites, Exercise, and Peripheral Arterial Disease (NO-PAD)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jason Allen, Ph.D., Duke University
ClinicalTrials.gov Identifier:
NCT01684930
First received: September 11, 2012
Last updated: September 29, 2014
Last verified: September 2014

September 11, 2012
September 29, 2014
June 2012
November 2014   (final data collection date for primary outcome measure)
Change In Exercise Capacity [ Time Frame: Baseline and 16 Weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01684930 on ClinicalTrials.gov Archive Site
  • Change in Functional Ability [ Time Frame: Baseline and 16 Weeks ] [ Designated as safety issue: No ]
    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.
  • Change In Vascular Function [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
    Ankle-brachial Index (ABI), Brachial artery flow-mediated dilation (BAFMD), calf blood flow (plethysmography), and arterial stiffness (pulse wave velocity and pulse wave reflection).
  • Change in Angiogenesis [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
    Gastrocnemius muscle biopsy will be performed to measure markers of angiogenesis including; capillaries per unit area and per muscle fiber, endothelial cells with surrounding pericytes, relative fraction of type I, IIa, IIb, and IId/x fibers. If differences exist we will look for changes in cell proliferation (PCNA) and apoptosis (TUNEL); (b) oxidative capacity including; mitochondria volume with citrate synthase activity. (c) mitochondrial volume and density; (d) mitochondrial oxygen efficiency (respiratory control ratio, the ratio of ATP phosphorylation rate per oxygen consumption rate (P/O ratio), and maximal rate of ATP production). These are measurements for potential mediation analyses and gaining insight into the relative effect sizes will inform mechanistic aims in a larger trial.
Same as current
Not Provided
Not Provided
 
Nitrites, Exercise, and Peripheral Arterial Disease
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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Peripheral Arterial Disease
  • Drug: Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training
    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 Name: James White Drinks
  • Other: Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training
    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 Name: James White Drinks
  • 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.
    Intervention: Drug: Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training
  • 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.
    Intervention: Other: Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
28
December 2015
November 2014   (final data collection date for primary outcome measure)

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
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01684930
Pro00031918, 1R21HL111972-01
No
Jason Allen, Ph.D., Duke University
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Jason Allen, PhD Duke University
Duke University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP