Dietary nitrate, oral bacteria, and blood pressure in children with primary hypertension
Investigation of the Relationship Between Dietary Nitrate and Oral Microbiota in Children With Primary Hypertension
We will test whether differences in mouth bacteria and how saliva handles dietary nitrate are linked to blood pressure in 10–18-year-olds with primary hypertension compared with healthy peers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | Istanbul University Academic / other |
| Locations | 1 site (Istanbul, Fatih) |
| Trial ID | NCT07236125 on ClinicalTrials.gov |
What this trial studies
This observational study will recruit 10–18-year-old participants with diagnosed primary hypertension and an age- and sex-matched healthy control group at Istanbul University Faculty of Dentistry. All participants will have non-invasive oral and dental exams, saliva sampling for nitrate/nitrite measurements, and oral microbiome profiling to identify nitrate-reducing bacteria. Blood pressure and related clinical data will be collected and compared between groups to look for correlations with salivary nitrite production and microbial composition. The study excludes recent antibiotic or mouthwash use and participants with periodontal disease to reduce confounding of the oral microbiome.
Who should consider this trial
Good fit: Ideal candidates are 10–18-year-olds diagnosed with primary hypertension, without secondary causes or systemic disease, not on chronic medications, and who have not used antibiotics or mouthwash in the past three months and have no active periodontal or oral mucosal disease.
Not a fit: Patients older than 18, those with secondary hypertension, systemic illnesses, recent antibiotic or mouthwash use, current periodontal disease, or on regular antihypertensive therapy are unlikely to qualify or benefit from the study findings.
Why it matters
Potential benefit: If successful, it could identify mouth bacteria or salivary markers that help detect high blood pressure earlier or point to non-drug strategies to improve blood pressure in young people.
How similar studies have performed: Adult studies have linked oral nitrate-reducing bacteria and salivary nitrite to blood pressure changes, but applying this approach to children is relatively novel and less studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Applied to the Istanbul University Faculty of Medicine, Department of Pediatric Nephrology, * Between the ages of 10 and 18, * Diagnosed with primary hypertension, * Clinically excluded from secondary hypertension or heart failure, * No systemic or chronic disease other than hypertension, * No periodontal disease, dental infection, or oral mucosal disease, * Not taking regular antihypertensive or other medications for a chronic disease, * Not having received antibiotic treatment in the last 3 months, * Patients who have not used mouthwash in the last 3 months, * Have no allergies to nitrate-rich foods, * Both male and female patients will be included. Exclusion Criteria: * Younger than 10 years of age or older than 18 years of age * Clinically diagnosed with secondary hypertension or heart failure * Have a systemic disease * Have periodontal disease, dental infection, or oral mucosal disease * Are taking regular antihypertensive medications or other chronic illnesses * Have received antibiotic treatment within the last 3 months * Have used mouthwash within the last 3 months * Are allergic to nitrate-rich foods will not be included in the study.
Where this trial is running
Istanbul, Fatih
- Istanbul University Faculty of Dentistry — Istanbul, Fatih, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Yelda Kasimoglu Assoc. Prof.
- Email: yelda.kasimoglu@iu.edu.tr
- Phone: +90 533 623 39 78
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.