Dietary Nitrate and Exercise to Augment Exercise Training Benefits in Subjects With DM+PAD (DM+PAD)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jason Allen, Ph.D., Duke University
ClinicalTrials.gov Identifier:
NCT01785524
First received: February 5, 2013
Last updated: November 25, 2015
Last verified: November 2015
Results First Received: November 25, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Peripheral Arterial Disease
Type II Diabetes Mellitus
Interventions: Drug: Beetroot Juice (Beet-It Stamina Shot) and Exercise Training
Other: Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
6,852 patients in Duke Cardiology and Vascular Surgery Clinics were screened, 392 potential study candidates were identified, and 18 subjects were enrolled from March 2013 through January 2014. Of the 18 subjects, 7 completed all study testing.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
BR Juice (Beet-It Stamina Shot) & Supervised 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.

Beetroot Juice (Beet-It Stamina Shot) and 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.

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.

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.


Participant Flow:   Overall Study
    BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training     BR Juice Placebo and Exercise Training  
STARTED     7     4  
COMPLETED     5     2  
NOT COMPLETED     2     2  
Withdrawal by Subject                 2                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BR Juice (Beet-It Stamina Shot) & Supervised 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.

Beetroot Juice (Beet-It Stamina Shot) and 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.

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.

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.

Total Total of all reporting groups

Baseline Measures
    BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training     BR Juice Placebo and Exercise Training     Total  
Number of Participants  
[units: participants]
  7     4     11  
Age  
[units: years]
Mean (Standard Deviation)
  70.1  (4.7)     74.25  (5.1)     71.63  (5.04)  
Gender  
[units: participants]
     
Female     1     1     2  
Male     6     3     9  



  Outcome Measures
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1.  Primary:   Change in Exercise Capacity - Maximal Oxygen Capacity (VO2peak)   [ Time Frame: Baseline & 16 Weeks ]

2.  Primary:   Change in Exercise Capacity - Time to Exhaustion (TTE)   [ Time Frame: Baseline & 16 Weeks ]

3.  Primary:   Change in Exercise Capacity - Claudication Onset Time (COT)   [ Time Frame: Baseline & 16 Weeks ]

4.  Secondary:   Change in Functional Ability   [ Time Frame: Baseline and 16 Weeks ]

5.  Secondary:   Change In Vascular Function   [ Time Frame: Baseline and 16 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Change in Angiogenesis   [ Time Frame: Baseline and 16 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The largest limitation to the study was the evolving knowledge on conversion rates of oral inorganic nitrate to nitrite. We found a good deal of unexpected inter and intra-subject variation in conversion rates.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jason D. Allen, PhD
Organization: Victoria University
phone: 61 3 9919 4264
e-mail: jason.allen@vu.edu.au



Responsible Party: Jason Allen, Ph.D., Duke University
ClinicalTrials.gov Identifier: NCT01785524     History of Changes
Other Study ID Numbers: Pro00039608
5R21HL113717-02 ( US NIH Grant/Contract Award Number )
Study First Received: February 5, 2013
Results First Received: November 25, 2015
Last Updated: November 25, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration