Cardiovascular DiseaseNCT01583803
Sex Differences in Oral Bacteria
An observational study of Cardiovascular Disease, run by Queen Mary University of London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2012to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community sample
Who may be able to join
- Healthy subjects aged 18-45 who have volunteered themselves and are willing to sign the consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Sex Differences in Oral Microbiota and Their Effect on Circulating Nitrite Levels
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
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Males | Not described | |
| Females | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial species identification
Measured: At baseline
Secondary outcomes (4)
Bacterial count
Measured: At baseline
Blood pressure
Measured: At baseline
Nitrogen oxide levels in biological fluids
Measured: At baseline
Oral nitrate reduction
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2014
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Principal investigator, Amrita Ahluwalia, Queen Mary University of London
- Investigators
- Amrita Ahluwalia, PhD, Principal investigator, Queen Mary University London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583803
- Sponsor's protocol ID
- 12/LO/0108
- Status last verified
- Dec 2016
- First submitted
- 20 Apr 2012
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 20585108Kapil 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.
PubMed 30031863
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Sex Differences in Oral Microbiota and Their Effect on Circulating Nitrite Levels
- ClinicalTrials.gov ID
- NCT01583803
- Acronym / sponsor ID
- 12/LO/0108
- Conditions
- Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- Jun 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2017 (estimated)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Males | – | – |
| Females | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample
Key inclusion criteria (1 listed)
- Healthy subjects aged 18-45 who have volunteered themselves and are willing to sign the consent form
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bacterial species identification
Time frame: At baseline
4 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2016.
- Background: PubMed 20585108Kapil 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.
- Derived from this study: PubMed 30031863Kapil 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amrita Ahluwalia, PhD principal investigator
Queen Mary University London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial species identification (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01583803, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2016.