Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Sex Differences in Oral Bacteria

This study is ongoing, but not recruiting participants.
King's College London
Information provided by (Responsible Party):
Amrita Ahluwalia, Queen Mary University of London Identifier:
First received: April 20, 2012
Last updated: April 8, 2014
Last verified: April 2014

April 20, 2012
April 8, 2014
June 2012
January 2014   (final data collection date for primary outcome measure)
Bacterial species identification [ Time Frame: At baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01583803 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
Sex Differences in Oral Bacteria
Investigation of the Sex Differences in Oral Microbiota and Their Effect on Circulating Nitrite Levels

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.

Not Provided
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA

Urine, saliva and plasma

Non-Probability Sample

Community sample

Cardiovascular Disease
Not Provided
  • Males
  • Females
Kapil V, Milsom AB, Okorie M, Maleki-Toyserkani S, Akram F, Rehman F, Arghandawi S, Pearl V, Benjamin N, Loukogeorgakis S, Macallister R, Hobbs AJ, Webb AJ, Ahluwalia A. Inorganic nitrate supplementation lowers blood pressure in humans: role for nitrite-derived NO. Hypertension. 2010 Aug;56(2):274-81. doi: 10.1161/HYPERTENSIONAHA.110.153536. Epub 2010 Jun 28. Erratum in: Hypertension. 2010 Sep;56(3):e37-9.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
June 2015
January 2014   (final data collection date for primary outcome measure)

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
18 Years to 45 Years
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Amrita Ahluwalia, Queen Mary University of London
Queen Mary University of London
King's College London
Principal Investigator: Amrita Ahluwalia, PhD Queen Mary University London
Queen Mary University of London
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP