Effects of Daily Nitrate Consumption on Oral Bacteria Composition, Blood Pressure and Vascular Fu… (NCT03784742) | Clinical Trial Compass
CompletedNot Applicable
Effects of Daily Nitrate Consumption on Oral Bacteria Composition, Blood Pressure and Vascular Function
United Kingdom28 participantsStarted 2018-12-01
Plain-language summary
Diseases of the heart and blood vessels, including raised blood pressure, are one of the leading causes of death worldwide. Higher intakes of dietary nitrate, found abundantly in root vegetables such as beetroot, have been shown to have health benefits including lowering blood pressure and improving the elasticity of blood vessels. Bacteria which reside in the mouth and those in the gastrointestinal tract play an important role in converting dietary nitrate to nitrite and nitric oxide (a chemical which promotes the relaxation of blood vessels). In particular, removal of oral bacteria by using antiseptic mouthwash is accompanied by an increase in blood pressure in subjects with normal blood pressure, even after consuming nitrate-rich foods. To date, very little is known about the role of these oral bacteria in the control of blood pressure, and if there are any differences in bacterial composition between individuals.
Who can participate
Age range
18 Years – 64 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;
* Blood pressure \<140/90 mm Hg;
* BMI range 18.5 - 39.9 kg/m2;
* Age 18-64 years;
* Non-smoking;
* Not taking blood pressure lowering medication or using medications known to influence vascular function such as a glyceryl trinitrate (GTN) spray;
* No recent (within 3 months) or current use of antibiotics.
Exclusion criteria are:
Diagnosed with a chronic illness;
* Anaemia defined as a haemoglobin \< 115 g/l for women and \<130 g/l for men;
* 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 including prebiotics and probiotics or have taken antibiotics within the last 3 months;
* Gingivitis diagnosis, or periodontal disease or chronic oral complaints or existing oral pathology.
* Less than four natural (enamel) buccal surfaces of upper molars available;
* Presence of fixed or removable oral appliances (e.g., dentures, orthodontic wires); xerostomia (a persistent dry mouth) diagnosis;
* Current smoker;
* Already participating in a dietary intervention study or clinical trial;
* Excessive alcohol consumption (\> 14 units/wk);
* Females who are pregnant or lactating;
* Individuals not willing to give up using mouthwash or change their dental hygiene routine. Regular consumption or use of xylitol-based products such as toothpaste and chewing gum.
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
Change in blood pressure measure
Timeframe: Before and after each 8 week intervention
2
Change in oral bacteria composition
Timeframe: Before and after each 8 week intervention