Sex Differences in Oral Bacteria

NCT01583803 | Unknown

• 1 other identifier: 12/LO/0108
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Bacterial species identification

  At baseline

Secondary Outcomes (4)

• Bacterial count

  At baseline

• Blood pressure

  At baseline

• Nitrogen oxide levels in biological fluids

  At baseline

• Oral nitrate reduction

  At baseline

Study Arms (2)

Males

Females

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

• Healthy subjects aged 18-45 who have volunteered themselves and are willing to sign the consent form

You may not qualify if:

• Healthy subjects unwilling to consent
• History of hypertension, diabetes or hypertensive on BP measurement
• Pregnant, or any possibility that a subject may be pregnant unless in the latter case a pregnancy test is performed with a negative result
• History of any serious illnesses, including recent infections or trauma
• Subjects taking systemic medication (other than the oral contraceptive pill)
• Subjects with self-reported use of mouthwash or tongue scrapes
• Subjects with recent or current antibiotic use (within 3 months)
• Subjects with a history, or recent treatment of (within last 3 months) of any oral condition (excluding caries), including gingivitis, periodontitis and halitosis

Sponsors & Collaborators

• Queen Mary University of London: lead
• King's College London: collaborator

Study Sites (1)

William Harvey Heart Centre

London, EC1M 6BQ, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 20585108 BACKGROUND

• 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.

  PMID: 30031863 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine, saliva and plasma

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Amrita Ahluwalia, PhD

  Queen Mary University London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Vascular Pharmacology

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: April 24, 2012
• Study Start: June 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2017
• Last Updated: December 21, 2016

Record last verified: 2016-12

Locations

GB (1)