This trial is active, not recruiting.

Condition cardiovascular disease
Sponsor Queen Mary University of London
Collaborator King's College London
Start date June 2012
End date January 2014
Trial size 24 participants
Trial identifier NCT01583803, 12/LO/0108


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Bacterial species identification
time frame: At baseline

Secondary Outcomes

Bacterial count
time frame: At baseline
Blood pressure
time frame: At baseline
Nitrogen oxide levels in biological fluids
time frame: At baseline
Oral nitrate reduction
time frame: At baseline

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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

Additional Information

Official title Investigation of the Sex Differences in Oral Microbiota and Their Effect on Circulating Nitrite Levels
Principal investigator Amrita Ahluwalia, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Queen Mary University of London.