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The Effects of Nitrate-Rich Mouthwash on Vascular Tone (NITRATONE)

19 maggio 2026 aggiornato da: Amina Basic, Göteborg University

The Short-Term Effects of Nitrate-Rich Mouthwash on Oral Bacterial Nitrite Production, Blood Pressure, and Nitrate and Nitrite Concentrations in Plasma and Saliva of Healthy Adults

High blood pressure (hypertension) is a major risk factor for cardiovascular disease. One important contributing factor to high blood pressure is reduced availability of nitric oxide (NO). Therefore, NO is an important molecule in maintaining healthy blood vessel function.

Dietary nitrate, found in leafy greens, can serve as an alternative source of nitric oxide in the body. After ingestion, nitrate is converted to nitrite by bacteria residing in the oral cavity. Nitrite can subsequently be converted to NO when swallowed. Therefore, this nitrate-nitrite-nitric oxide pathway is dependent on oral bacteria.

This study aims to assess whether rinsing the mouth with a nitrate-rich mouth rinse influences blood pressure in healthy adults. Also, concentrations of nitrate and nitrite in plasma and saliva will be measured following the nitrate-mouth rinse exposure.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study investigates the potential acute blood pressure lowering effects of a simple nitrate-rich mouth rinse and drink, while also monitoring their effects on oral nitrite production capacity (NPC), plasma and salivary nitrate and nitrite levels, oral pH levels and the oral microbiology.

The study is a short-term, double-blind, randomized, placebo-controlled, crossover trial.

Participants will receive interventions and donate samples at four separate sessions. At session (i), baseline measurements are taken prior to intervention, and samples are subsequently taken (as described under outcome measures). At session (i) and (ii), the participants will rinse the oral cavity with a nitrate-rich fluid (or placebo). Similarly for sessions (iii) and (iv), the participants will drink the same fluid (or placebo). When donating samples, the participants will be in fasting condition. In total there will be four sessions per participant with wash-out periods in-between.

To elucidate the short-term effects of the above-described interventions, sampling will be performed in the clinic at multiple time points during the first 2 hours after each intervention, as well as at 24 hours. Participants will also monitor their blood pressure at home at four different time points for all four interventions. No sampling or measurements will be performed during night-time.

For both the intervention and the placebo, potassium (K) salts are used (KNO3 and KCl). For chairside measurement of NPC in oral samples, the rapid Griess assay (RGA) will be used. Blood pressure will be measured at the study facilities as clinic blood pressure and orthostatic blood pressure (CBP and OBP, respectively) using a clinically validated blood pressure monitor. The same device will be used by the participants for home blood pressure measurements (HBP). Saliva pH will be measured using pH-sticks or a pH-meter. Plasma and saliva nitrate- and nitrite levels are analyzed using commercial laboratory kits. Salivary secretion rate (SCR) is recorded during saliva donation, and measured as volume per unit time. Microbiological effects will be analyzed with appropriate methods in the laboratory.

Tipo di studio

Interventistico

Iscrizione (Stimato)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Amina Basic, PhD, DDS
  • Numero di telefono: +46766185930
  • Email: amina.basic@gu.se

Luoghi di studio

  • Svezia
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Svezia, 41390
        • Odontologen, University of Gothenburg
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • ≥18 years of age; and
  • clinic blood pressure <140/<90 mmHg.

Exclusion criteria:

  • hypertension;
  • systemic medication (other than the oral contraceptive pill);
  • antibiotic treatment within the last 3 months;
  • active smoking status and BMI > 30;
  • prior gastric by-pass surgery;
  • self-reported use of antiseptic mouthwash or toothpaste;
  • self-reported use of tongue scrapes; and
  • active periodontal disease or caries that needs treatment.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Test mouth rinse
In this arm participants will receive nitrate rich-mouth rinse
Integratore alimentare: Nitrate-rich mouth rinse
The oral cavity is rinsed with nitrate from mouth rinse, rather than ingested.
Altri nomi:
  • Nitrate mouth rinse
Comparatore placebo: Placebo mouth rinse
In this arm participants will receive placebo mouth rinse
Integratore alimentare: Placebo
This mouth rinse is devoid of nitrates
Integratore alimentare: Placebo
This drink is devoid of nitrates
Comparatore attivo: Test drink
In this arm participants will receive nitrate-rich drink
Integratore alimentare: Nitrate-rich drink
Nitrate is ingested, rather than rinsed and spit out
Altri nomi:
  • Nitrate drink
Comparatore placebo: Placebo drink
In this arm participants will receive placebo drink
Integratore alimentare: Placebo
This mouth rinse is devoid of nitrates
Integratore alimentare: Placebo
This drink is devoid of nitrates

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Blood pressure before and at regular intervals within the 24 hours after nitrate exposure.
Lasso di tempo: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Blood pressure will be measured before and with regular intervals after nitrate exposure. The measurements will be registered as systolic and diastolic measurements from clinic blood pressure and home blood pressure.
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Oral nitrite production before and at regular intervals within the 24 hours after nitrate exposure.
Lasso di tempo: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure
The nitrite production is measured using the rapid Griess assay (RGA) - a chairside semi-quantitative nitrite concentration estimation tool for use in several different oral samples. The RGA provides nitrite estimation on a grading scale of 0-5 with nitrite concentrations intervals.
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Plasma and salivary nitrate and nitrite levels before and after nitrate exposure.
Lasso di tempo: Baseline (prior to nitrate exposure) and 1 hour after nitrate exposure.
Blood samples are drawn from venous blood before and 1 hour after nitrate exposure, and plasma is separated. Saliva nitrate/nitrite is extracted from saliva samples donated before and 1 hour after nitrate exposure. Both are analyzed using commercial laboratory kits.
Baseline (prior to nitrate exposure) and 1 hour after nitrate exposure.
Salivary pH levels at regular intervals.
Lasso di tempo: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Salivary pH will be measured using a pH-stick at regular intervals before and after nitrate exposure.
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Orthostatic blood pressure before and at regular intervals within the 24 hours after nitrate exposure.
Lasso di tempo: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Orthostatic blood pressure will be measured at regular intervals before and after nitrate exposure and reported as systolic and diastolic blood pressure values in mmHg.
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Salivary secretion rate before and after nitrate exposure.
Lasso di tempo: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Salivary secretion rate will be registered as volume per unit time when donating saliva before and after nitrate exposure with regular intervals.
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Relative abundance in cultivable oral microbial composition after nitrate exposure
Lasso di tempo: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Microbial samples from multiple oral sites will be collected before and after nitrate exposure. Oral microbial composition will be analyzed and reported as the relative abundance (%).
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Absolute abundance in cultivable oral microbial composition after nitrate exposure
Lasso di tempo: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Microbial samples from multiple oral sites will be collected before and after nitrate exposure. Cultivable oral microbial composition will be analyzed and reported as absolute abundance and expressed as colony-forming units per milliliter (CFU/mL).
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
PCR detection of specific oral bacterial after nitrate exposure
Lasso di tempo: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Microbial samples from multiple oral sites will be collected before and after nitrate exposure. Quantitative PCR analysis will be performed for selected oral bacterial species and reported as bacterial counts or copy numbers.
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Oral microbial metabolite concentrations after nitrate exposure
Lasso di tempo: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Microbial samples from multiple oral sites will be collected before and after nitrate exposure. Oral microbial metabolites will be analyzed and reported as metabolite concentration values.
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Göteborg University

Investigatori

  • Investigatore principale: Amina Basic, PhD, DDS, Göteborg University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 aprile 2026

Completamento primario (Stimato)

1 dicembre 2028

Completamento dello studio (Stimato)

1 dicembre 2028

Date di iscrizione allo studio

Primo inviato

29 dicembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

19 maggio 2026

Primo Inserito (Effettivo)

22 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 maggio 2026

Ultimo verificato

1 dicembre 2025

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 2025-02639-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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