The Chronic Effects of Beetroot Juice in Hypertensive Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amrita Ahluwalia, Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT01405898
First received: July 28, 2011
Last updated: December 8, 2015
Last verified: December 2015
Results First Received: November 3, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Condition: Hypertension
Interventions: Dietary Supplement: beetroot juice
Dietary Supplement: Nitrate-free beetroot juice

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Beetroot Juice Beetroot juice, 4 weeks 250ml daily
Nitrate-free Beetroot Juice Nitrate-free beetroot juice, 4 weeks 250ml daily

Participant Flow:   Overall Study
    Beetroot Juice     Nitrate-free Beetroot Juice  
STARTED     34     34  
COMPLETED     32     32  
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.
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Reporting Groups
  Description
Beetroot Juice Beetroot juice 4 weeks 250ml daily
Nitrate-free Beetroot Juice Nitrate-free beetroot juice, 4 weeks 250ml daily
Total Total of all reporting groups

Baseline Measures
    Beetroot Juice     Nitrate-free Beetroot Juice     Total  
Number of Participants  
[units: participants]
  32     32     64  
Age  
[units: years]
Mean (Standard Deviation)
  57.6  (13.9)     56.3  (16.4)     56.9  (15.1)  
Gender  
[units: participants]
     
Female     16     22     38  
Male     16     10     26  



  Outcome Measures
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1.  Primary:   Difference in Change in Clinic Systolic Blood Pressure From Baseline   [ Time Frame: 4 weeks ]

2.  Primary:   Difference in Change in Clinic Diastolic Blood Pressure From Baseline   [ Time Frame: 4 weeks ]

3.  Primary:   Difference in Change in Ambulatory Systolic Blood Pressure From Baseline   [ Time Frame: 4 weeks ]

4.  Primary:   Difference in Change in Ambulatory Diastolic Blood Pressure From Baseline   [ Time Frame: 4 weeks ]

5.  Secondary:   Difference in Change in Plasma Nitrite Concentration From Baseline   [ Time Frame: 4 weeks ]

6.  Secondary:   Difference in Change in Endothelial Function From Baseline   [ Time Frame: 4 weeks ]

7.  Secondary:   Difference in Change in Arterial Stiffness From Baseline   [ Time Frame: 4 weeks ]


  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
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  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: Professor Amrita Ahluwalia
Organization: Queen Mary University London
phone: 02078825720
e-mail: a.ahluwalia@qmul.ac.uk


No publications provided by Queen Mary University of London

Publications automatically indexed to this study:

Responsible Party: Amrita Ahluwalia, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01405898     History of Changes
Other Study ID Numbers: 08/H0703/91 Chronic
Study First Received: July 28, 2011
Results First Received: November 3, 2015
Last Updated: December 8, 2015
Health Authority: UK: East London & City Research Ethics Committee 1