Clinical trial NCT01583803: Sex Differences in Oral Bacteria
Official title: Investigation of the Sex Differences in Oral Microbiota and Their Effect on Circulating Nitrite Levels
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Disease
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2012-04-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Bacterial species identification
timeFrame: At baseline
Secondary outcomes:
measure: Bacterial count
timeFrame: At baseline
measure: Blood pressure
timeFrame: At baseline
measure: Nitrogen oxide levels in biological fluids
timeFrame: At baseline
measure: Oral nitrate reduction
timeFrame: At baseline
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: William Harvey Heart Centre
Study officials:
affiliation: Queen Mary University London
name: Amrita Ahluwalia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kapil V, Rathod KS, Khambata RS, Bahra M, Velmurugan S, Purba A, S Watson D, Barnes MR, Wade WG, Ahluwalia A. Sex differences in the nitrate-nitrite-NO* pathway: Role of oral nitrate-reducing bacteria. Free Radic Biol Med. 2018 Oct;126:113-121. doi: 10.1016/j.freeradbiomed.2018.07.010. Epub 2018 Jul 20.