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Sex Differences in Oral Bacteria

This study is not yet open for participant recruitment.
Verified April 2012 by Queen Mary University of London
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
Amrita Ahluwalia, Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT01583803
First received: April 20, 2012
Last updated: April 24, 2012
Last verified: April 2012
History of Changes
  Purpose

Females have a lower incidence of hypertensive and cardiovascular disorders that may relate to differences in nitrogen oxides in the blood and saliva. Some nitrogen oxides are recycled with the help of oral bacteria to nitric oxide which is protective against vascular disorders. This study will test the hypothesis that females have different numbers and species of these nitrogen-oxide reducing bacteria.


Condition
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of the Sex Differences in Oral Microbiota and Their Effect on Circulating Nitrite Levels

Further study details as provided by Queen Mary University of London:

Primary Outcome Measures:
  • Bacterial species identification [ Time Frame: At baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bacterial count [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Nitrogen oxide levels in biological fluids [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Oral nitrate reduction [ Time Frame: At baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Urine, saliva and plasma


Estimated Enrollment: 24
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Males
Females

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community sample

Criteria

Inclusion Criteria:

  • Healthy subjects aged 18-45 who have volunteered themselves and are willing to sign the consent form

Exclusion Criteria:

  1. Healthy subjects unwilling to consent
  2. History of hypertension, diabetes or hypertensive on BP measurement
  3. Pregnant, or any possibility that a subject may be pregnant unless in the latter case a pregnancy test is performed with a negative result
  4. History of any serious illnesses, including recent infections or trauma
  5. Subjects taking systemic medication (other than the oral contraceptive pill)
  6. Subjects with self-reported use of mouthwash or tongue scrapes
  7. Subjects with recent or current antibiotic use (within 3 months)
  8. Subjects with a history, or recent treatment of (within last 3 months) of any oral condition (excluding caries), including gingivitis, periodontitis and halitosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583803

Contacts
Contact: Vikas Kapil, MBBS 02078828931 v.kapil@qmul.ac.uk

Locations
United Kingdom
William Harvey Heart Centre Not yet recruiting
London, United Kingdom, EC1M 6BQ
Contact: Vikas Kapil, MBBS     020 7882 8931     v.kapil@qmul.ac.uk    
Principal Investigator: Amrita Ahluwalia, PhD            
Sponsors and Collaborators
Queen Mary University of London
King's College London
Investigators
Principal Investigator: Amrita Ahluwalia, PhD Queen Mary University London
  More Information

Additional Information:
Link to participant information  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Amrita Ahluwalia, Professor of Vascular Pharmacology, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01583803     History of Changes
Other Study ID Numbers: 12/LO/0108
Study First Received: April 20, 2012
Last Updated: April 24, 2012
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013