Sex Differences in Oral Bacteria

Cardiovascular Disease Clinical Trial

Official title:

Investigation of the Sex Differences in Oral Microbiota and Their Effect on Circulating Nitrite Levels

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01583803
• Other study ID #: 12/LO/0108
• Status: Active, not recruiting
• Phase: N/A
• First received: April 20, 2012
• Last updated: December 20, 2016
• Start date: June 2012
• Est. completion date: June 2017

Study information

• Verified date: December 2016
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: June 2017
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Locations

Country	Name	City	State
United Kingdom	William Harvey Heart Centre	London

Sponsors (2)

Lead Sponsor	Collaborator
Queen Mary University of London	King's College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. Erratum in: Hypertension. 2010 Sep;56(3):e37-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial species identification		At baseline	No
Secondary	Bacterial count		At baseline	No
Secondary	Blood pressure		At baseline	No
Secondary	Nitrogen oxide levels in biological fluids		At baseline	No
Secondary	Oral nitrate reduction		At baseline	No