Dietary Nitrate and the Oral Microbiome in Children With Primary Hypertension

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-18
SponsorYelda Kasımoğlu

About this trial

Children and adolescents with primary hypertension (high blood pressure without an underlying secondary cause) are at increased risk of cardiovascular disease in adulthood. Recent research suggests that not only the heart and blood vessels, but also the bacteria living in the mouth may play a role in blood pressure regulation. Certain oral bacteria can convert nitrate from food into nitrite and then into nitric oxide, a substance that helps blood vessels relax. If this nitrate-nitrite-nitric oxide pathway is impaired, blood pressure may rise.

This study aims to investigate the relationship between oral microbiota, salivary nitric oxide reductase activity and blood pressure in children and adolescents with primary hypertension compared with healthy peers. We will recruit participants aged 10-18 years who have a diagnosis of primary hypertension and an age- and sex-matched control group without hypertension.

All participants will undergo a non-invasive oral and dental examination and standardized blood pressure measurements. Saliva samples will be collected to measure pH, flow rate, nitrate and nitrite levels, total protein, lysozyme activity and to analyze the composition of oral bacteria using modern DNA-based techniques. Participants and/or their parents will also complete brief questionnaires about diet and general health.

No medication or dietary supplement will be given as part of the study, and no additional blood samples will be taken beyond routine clinical care. The main risk is minimal discomfort related to oral examination and saliva collection. There is no guaranteed direct benefit for participants; however, the results may help us better understand how oral bacteria and salivary nitric oxide pathways are linked to high blood pressure in young people. This knowledge may support the development of new non-invasive strategies for early detection and prevention of hypertension in the future.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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,

Disqualifiers

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

Trial population

Participants will be recruited from children and adolescents aged 10-18 years presenting to the Istanbul University Faculty of Dentistry, Department of Pediatric Dentistry, as well as pediatric patients followed by the Pediatric Nephrology Clinic who have been diagnosed with primary hypertension. The study population includes two groups: (1) adolescents with confirmed primary hypertension, not on antihypertensive medication, and (2) age- and sex-matched healthy controls without systemic disease or blood pressure abnormalities. All participants will be systemically healthy, cooperative, and able to provide saliva samples, undergo oral examinations, and complete questionnaire assessments. Recruitment will be consecutive based on clinic attendance, and all participants and their families will be informed about study procedures before enrollment.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • No active intervention

    Other intervention

    This is an observational study with no active intervention. No drug, device, behavioral, dietary, surgical, or diagnostic intervention is administered to participants. All study procedures, including oral examination, salivary sampling, pH measurement, biochemical tests, and blood pressure assessment, are non-interventional and part of standard clinical evaluation. The study only aims to observe natural variations in oral microbiota composition, nitrate-reducing activity, and blood pressure without changing participants' medical care.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Patients with primary hypertension1 intervention
Group B: Healthy controls1 intervention

Trial outcomes

Primary outcomes

1

Microbiota Composition (16S rRNA Sequencing)

Characterization of bacterial community diversity and relative abundance in unstimulated saliva using 16S rRNA gene sequencing. Analysis will include alpha diversity, beta diversity, and differential taxa abundance between groups, with a focus on nitrate-reducing genera such as Neisseria, Rothia, and Actinomyces.

Time frame
Baseline

Secondary outcomes

1

Salivary Nitrate and Nitrite Levels

Quantitative measurement of salivary nitrate-to-nitrite conversion capacity using colorimetric assays. The activity of nitrate-reducing oral bacteria will be assessed by determining nitrite concentrations produced in vitro from standardized nitrate substrate under controlled incubation. Higher nitrite output indicates higher nitrate-reductase activity. Values will be compared between primary hypertension patients and healthy controls.

Time frame
Baseline (single visit)
2

Salivary pH

Salivary acidity/alkalinity measured using validated pH indicator strips immediately after sample collection. Values will be compared between hypertensive and healthy groups.

Time frame
Baseline
3

Salivary Flow Rate

Unstimulated salivary flow rate (mL/min) collected over a timed period (5 minutes). Reduced flow may influence oral microbiota composition and nitrate metabolism.

Time frame
baseline
4

Salivary Lysozyme Activity

Quantitative assessment of innate immune enzyme lysozyme using a commercial colorimetric assay. Alterations in antimicrobial enzyme levels may influence microbial ecology.

Time frame
baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yelda Kasımoğlu

Lead sponsor

Istanbul University

Sponsor institution

Istanbul University Scientific Research Projects Coordination Unit- Pending

Collaborator