Nitrites, Exercise, and Peripheral Arterial Disease - Clinical Trial for Peripheral Arterial Disease | NCT01684930

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training

Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Cardiovascular Diseases, Vascular Diseases, Arterial Occlusive Diseases, Exercise, Functional Capacity

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Duke Diet & Fitness Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BR Juice (Beet-It Stamina Shot) and Exercise Training

BR Juice Placebo and Exercise Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Exercise Capacity: VO2peak (Maximal Oxygen Consumption)

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.

Change In Time To Exhaustion

Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of total time to exhaustion.

Secondary Outcome Measures

Change in Functional Ability

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 Claudication Onset Time

Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of claudication onset time.

Change In Vascular Function (BAFMD)

Vascular Function is measured as Brachial artery flow-mediated dilation (BAFMD). BAFMD is a measure of change in artery diameter after a stimulus .

Change in Angiogenesis

Gastrocnemious muscle biopsy will be performed to measure the number of capillaries per fibre as a marker of change in angiogenesis between groups

Full Information

NCT ID

NCT01684930

First Posted

September 11, 2012

Last Updated

August 26, 2017

Sponsor

Duke University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT01684930

Brief Title

Nitrites, Exercise, and Peripheral Arterial Disease

Acronym

NO-PAD

Official Title

Increased Plasma Nitrite, Tissue Oxygenation and Functional Changes in PAD

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Duke University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease

Keywords

Cardiovascular Diseases, Vascular Diseases, Arterial Occlusive Diseases, Exercise, Functional Capacity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BR Juice (Beet-It Stamina Shot) and Exercise Training

Arm Type

Experimental

Arm Description

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.

Arm Title

BR Juice Placebo and Exercise Training

Arm Type

Placebo Comparator

Arm Description

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 Type

Drug

Intervention Name(s)

Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training

Other Intervention Name(s)

James White Drinks

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training

Other Intervention Name(s)

James White Drinks

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Exercise Capacity: VO2peak (Maximal Oxygen Consumption)

Description

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.

Time Frame

Baseline and 16 Weeks

Title

Change In Time To Exhaustion

Description

Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of total time to exhaustion.

Time Frame

Baseline and 16 weeks

Secondary Outcome Measure Information:

Title

Change in Functional Ability

Description

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.

Time Frame

Baseline and 16 Weeks

Title

Change In Claudication Onset Time

Description

Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of claudication onset time.

Time Frame

Baseline and 16 weeks

Title

Change In Vascular Function (BAFMD)

Description

Vascular Function is measured as Brachial artery flow-mediated dilation (BAFMD). BAFMD is a measure of change in artery diameter after a stimulus .

Time Frame

Baseline and 16 weeks

Title

Change in Angiogenesis

Description

Gastrocnemious muscle biopsy will be performed to measure the number of capillaries per fibre as a marker of change in angiogenesis between groups

Time Frame

Baseline and 16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jason Allen, PhD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke Diet & Fitness Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29976553

Citation

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.

Results Reference

derived

PubMed Identifier

28974486

Citation

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.

Results Reference

derived

Links:

URL

http://cardiology.medicine.duke.edu/research/clinical-research/frederick-r-cobb-non-invasive-vascular-research-laboratory

Description

Frederick R. Cobb Non-Invasive Vascular Research Laboratory

URL

http://www.dukehealth.org/clinicaltrials/20120705125024398

Description

Duke Clinical Trials Listing

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

Peripheral Arterial Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial