Completed
NO-PADIncreased Plasma Nitrite, Tissue Oxygenation and Functional Changes in PAD
What is being tested
Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training
+ Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training
DrugOther
Who is being recruted
Arteriosclerosis+6
+ Behavior
+ Peripheral Vascular Diseases
From 40 to 75 Years
+12 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 2
Interventional
Study Start: June 2012
Summary
Principal SponsorDuke University
Last updated: August 29, 2017
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2012
Actual date on which the first participant was enrolled.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).
Principal SponsorDuke University
Last updated: August 29, 2017
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
32 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 40 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
ArteriosclerosisBehaviorPeripheral Vascular DiseasesAtherosclerosisArterial Occlusive DiseasesCardiovascular DiseasesMotor ActivityVascular DiseasesPeripheral Arterial Disease
Criteria
2 inclusion criteria required to participate
Intermittent Claudication for 3 or more months
Peripheral Arterial Disease (ABI of less than 0.9)
10 exclusion criteria prevent from participating
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
Gangrene, impending limb loss or osteomyelitis
Individuals who have suffered a heart attack or stroke, or have changes on a resting ECG, in the last 3 months
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalSubjects 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.
Group II
PlaceboSubjects 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.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Duke Diet & Fitness Center
Durham, United StatesOpen Duke Diet & Fitness Center in Google MapsCompletedOne Study Center