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Influence of Dietary Nitrate on Vascular Dysfunction and Inflammation

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ClinicalTrials.gov Identifier: NCT02715635
Recruitment Status : Recruiting
First Posted : March 22, 2016
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Amrita Ahluwalia, Queen Mary University of London

Brief Summary:
The principal research objective is to determine whether inorganic nitrate in the form of beetroot juice compared to placebo control prevents the systemic inflammation that underlies typhoid vaccine-induced endothelial dysfunction

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Biological: Typhoid vaccine Dietary Supplement: Concentrate beetroot Juice Dietary Supplement: Concentrate beetroot Juice (Placebo) Phase 1

Detailed Description:
We wish to determine in a prospective manner whether inorganic nitrate affects the endothelial dysfunction induced by systemic inflammation. At baseline we will measure flow-mediated dilatation (FMD) and peripheral augmentation index, as well as aortic stiffness, as measured by pulse wave velocity (PWV). Volunteers will then receive ~8 mmols of dietary nitrate or nitrate free placebo juice once daily for 6 days. After this, depending on availability, volunteers will receive a typhoid vaccine Typherix®, GlaxoSmithKline UK or Typhim Vi ™, AAH Pharmaceuticals Ltd). This vaccine generates a mild systemic inflammation that is associated with vascular dysfunction. All vascular function measures will be repeated at 8 hours and 32 hours after vaccine administration.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double-blind, Randomised, Placebo-controlled Parallel Study to Investigate the Effect of Dietary Nitrate on a Model of Vascular Dysfunction in Healthy Volunteers
Study Start Date : April 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nitrate-rich beetroot juice

Biological: Typhoid vaccine The typhoid vaccine is composed of purified polysaccharide from S. typhi capsule 25 micrograms contained in 0.5 ml solution Other Name: Typhim Vi®

Dietary Supplement: Concentrate beetroot Juice 140 ml containing ~8 mmol of inorganic nitrate

Biological: Typhoid vaccine
The typhoid vaccine is composed of purified polysaccharide from S. typhi capsule 25 micrograms contained in 0.5 ml solution
Other Name: Typhim Vi®

Dietary Supplement: Concentrate beetroot Juice
140 ml containing ~8 mmol of inorganic nitrate

Placebo Comparator: Nitrate-deplete beetroot juice

Biological: Typhoid vaccine The typhoid vaccine is composed of purified polysaccharide from S. typhi capsule 25 micrograms contained in 0.5 ml solution Other Name: Typhim Vi®

Dietary Supplement: Concentrate beetroot Juice 140 ml which is nitrate-depleted

Biological: Typhoid vaccine
The typhoid vaccine is composed of purified polysaccharide from S. typhi capsule 25 micrograms contained in 0.5 ml solution
Other Name: Typhim Vi®

Dietary Supplement: Concentrate beetroot Juice (Placebo)
140 ml which is nitrate-depleted




Primary Outcome Measures :
  1. Flow mediated dilatation [ Time Frame: Day 1, Day 7 (8 hours post typhoid vaccine), Day 8 (32 hours post typhoid vaccine) ]
    Comparison of change in FMD from baseline after typhoid vaccination following inorganic nitrate versus placebo supplementation

  2. Plasma nitrite concentration [ Time Frame: Day 1, Day 7 (8 hours post typhoid vaccine), Day 8 (32 hours post typhoid vaccine) ]
    Comparison of change in plasma nitrite concentration following inorganic nitrate versus placebo supplementation


Secondary Outcome Measures :
  1. Markers of acute inflammation [ Time Frame: Day 1, Day 7 (8 hours post typhoid vaccine), Day 8 (32 hours post typhoid vaccine) ]
    Comparison of change in peripheral markers of inflammation and leucocyte count following nitrate versus placebo supplementation

  2. Pulse wave velocity [ Time Frame: Day 1, Day 7 (8 hours post typhoid vaccine), Day 8 (32 hours post typhoid vaccine) ]
    Comparison of change in PWV from baseline after typhoid vaccination following nitrate versus placebo supplementation

  3. Platelet reactivity [ Time Frame: Day 1, Day 7 (8 hours post typhoid vaccine), Day 8 (32 hours post typhoid vaccine) ]
    Comparison of change in platelet reactivity from baseline after typhoid vaccination following nitrate versus placebo supplementation

  4. Plasma nitrate concentration [ Time Frame: Day 1, Day 7 (8 hours post typhoid vaccine), Day 8 (32 hours post typhoid vaccine) ]
    Comparison of change in plasma nitrate concentration following inorganic nitrate versus placebo supplementation



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy volunteers
  2. Aged 18-45
  3. Volunteers who are willing to sign the consent form.
  4. Normal resting blood pressure (<140/90 mmHg)

Exclusion Criteria:

  1. Healthy subjects unwilling to consent
  2. Pregnant, or any possibility that a subject may be pregnant unless in the latter case a pregnancy test is performed with a negative result
  3. History of any serious illnesses, including recent infections or trauma
  4. Subjects taking systemic medication (other than the oral contraceptive pill)
  5. Subjects with self-reported use of mouthwash or tongue scrapes
  6. Subjects with recent (3 months) or current antibiotic use
  7. Subjects with a history, or recent treatment of (within last 3 months) any oral condition (excluding caries), including gingivitis, periodontitis and halitosis
  8. Subjects with a history of typhoid vaccination in the last 6 months
  9. Subjects with any history of a blood-borne infectious disease such Hepatitis B or C virus, or HIV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715635


Contacts
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Contact: Amrita Ahluwalia, BSc PhD 0207 882 8377 a.ahluwalia@qmul.ac.uk
Contact: Krishnaraj S Rathod, BMedSci MBBS 0207 882 8931 k.s.rathod@qmul.ac.uk

Locations
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United Kingdom
William Harvey Research Institute, Barts and The London School of Medicine Recruiting
London, United Kingdom, EC1M 6BQ
Contact: Krishnaraj Rathod, BMedSci MBBS    0207 882 8931    k.s.rathod@qmul.ac.uk   
Principal Investigator: Amrita Ahluwalia, BSc PhD         
Sub-Investigator: Krishnaraj S Rathod, BMedSci MBBS         
Sub-Investigator: Vikas Kapil, MBChB PhD         
Sub-Investigator: Rayomand S Khambata, BSc PhD         
Sponsors and Collaborators
Queen Mary University of London
Investigators
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Principal Investigator: Amrita Ahluwalia, BSc PhD William Harvey Research Institute, Barts and The London, Queen Mary's School of Medicine and Dentistry

Publications:
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Responsible Party: Amrita Ahluwalia, Deputy Director of The William Harvey Research Institute, Prof of Vascular Pharmacology, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT02715635     History of Changes
Other Study ID Numbers: 15/LO/0789
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Cardiovascular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs