Sex Differences in Oral Bacteria

• Sponsor: Queen Mary University of London (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01583803
• Collaborator: King's College London (Other)
• Enrollment: 24
• Location: 1
• Duration (Months): 60
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease

Study Design

• Study Type: Observational
• Anticipated Enrollment: 24 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Investigation of the Sex Differences in Oral Microbiota and Their Effect on Circulating Nitrite Levels
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Jan 1, 2014
• Anticipated Study Completion Date: Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Males
Females

Outcome Measures

Primary Outcome Measures

1. Bacterial species identification [At baseline]

Secondary Outcome Measures

1. Bacterial count [At baseline]

2. Blood pressure [At baseline]

3. Nitrogen oxide levels in biological fluids [At baseline]

4. Oral nitrate reduction [At baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	William Harvey Heart Centre	London		United Kingdom	EC1M 6BQ

Sponsors and Collaborators

• Queen Mary University of London
• King's College London

Investigators

• Principal Investigator: Amrita Ahluwalia, PhD, Queen Mary University London

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Erratum in: Hypertension. 2017 Feb;69(2):e1.

• Responsible Party: Amrita Ahluwalia, Professor of Vascular Pharmacology, Queen Mary University of London
• ClinicalTrials.gov Identifier: NCT01583803
• Other Study ID Numbers: 12/LO/0108
• First Posted: Apr 24, 2012
• Last Update Posted: Dec 21, 2016
• Last Verified: Dec 1, 2016

• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of Dec 21, 2016