Examination of the Distribution of Nitrate Reducing Bacteria in the Human Oral Cavity (NCT03068962) | Clinical Trial Compass
UnknownNot Applicable
Examination of the Distribution of Nitrate Reducing Bacteria in the Human Oral Cavity
United Kingdom20 participantsStarted 2017-03
Plain-language summary
Dietary nitrate have been shown to have health benefits including lowering blood pressure (Hobbs et al, 2012), improving endothelial function and inhibiting platelet aggregation in healthy humans (Lidder \& Webb, 2013). The main sources of dietary nitrate in the human diet are vegetables such as beetroot. Nitrates are converted to nitrites then nitric oxide (NO), following their reduction by commensal oral bacteria and those residing in the gastrointestinal tract (Hord, Tang, \& Bryan, 2009; Lidder \& Webb, 2013). A recent study has shown following elimination of oral bacteria by the use of a chlorhexidine based antiseptic mouthwash, the conversion of nitrate to nitrite is prevented and this is accompanied by a statistically significant increase in blood pressure in normotensive subjects (Kapil et al., 2013). To date, very few studies have investigated the potential role of these oral bacteria in control of blood pressure and if there are any inter and intra-individual differences in bacterial composition.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female
* A signed consent form
* Age 18-55 years
* Non-smoking, healthy individuals
* BMI 18.5 - 30 kg/m2
Exclusion Criteria:
* Diagnosed with a chronic illness
* Individuals with food allergies or allergies to medicated mouthwash or ingredients in the oral products
* Requirements to take long-term medication active on the oral cavity or taken antibiotics within the last 3 months
* Current diagnosis of dental caries, gingivitis, or periodontal disease or chronic oral complaints or Existing oral pathology (active caries lesions and/or periodontal disease; mucosal lesions; poor occlusion)
* Current smoker (regular and electronic cigarettes and cigars)
* Participating in a dietary intervention study.
* Excessive alcohol consumption (\> 21 units/wk male, \>14 units/wk female)
* Females who are pregnant or lactating
* Reduced salivary flow (unstimulated flow less than 0.1 ml/min);
* less than four natural (enamel) buccal surfaces of upper molars available;
* presence of fixed or removable oral appliances (e.g., dentures, orthodontic wires)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
oral bacteria sample will be collected to Identification of nitrate reductase-positive bacteria in the oral cavity and capacity to reduce dietary nitrate