Status:
COMPLETED
Effects of Daily Nitrate Consumption on Oral Bacteria Composition, Blood Pressure and Vascular Function
Lead Sponsor:
University of Reading
Collaborating Sponsors:
Saudi Cultural Bureau
Conditions:
No Dental Disease
Non-smoking
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief 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 ...
Detailed Description
Interested volunteers will be provided with an outline of the study and asked to complete a medical and lifestyle questionnaire (in person, by email or over the phone). Potentially suitable participan...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03784742
Start Date
December 1 2018
End Date
December 1 2021
Last Update
April 12 2024
Active Locations (1)
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1
Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, United Kingdom, RG6 6AP