NCT07236125 Dietary Nitrate and the Oral Microbiome in Children With Primary Hypertension
| NCT ID | NCT07236125 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yelda Kasımoğlu |
| Condition | Primary Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 48 participants |
| Start Date | 2026-04-15 |
| Primary Completion | 2026-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 48 participants in total. It began in 2026-04-15 with a primary completion date of 2026-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07236125 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 18 Years, studying Primary Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07236125 currently recruiting?
Yes, NCT07236125 is actively recruiting participants. Contact the research team at yelda.kasimoglu@iu.edu.tr for enrollment information.
Where is the NCT07236125 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07236125 clinical trial?
NCT07236125 is sponsored by Yelda Kasımoğlu. The trial plans to enroll 48 participants.