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

19. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Sverige
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Sverige, 41390
        • Odontologen, University of Gothenburg
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Test mouth rinse
In this arm participants will receive nitrate rich-mouth rinse
Kosttilskud: Nitrate-rich mouth rinse
The oral cavity is rinsed with nitrate from mouth rinse, rather than ingested.
Andre navne:
  • Nitrate mouth rinse
Placebo komparator: Placebo mouth rinse
In this arm participants will receive placebo mouth rinse
Kosttilskud: Placebo
This mouth rinse is devoid of nitrates
Kosttilskud: Placebo
This drink is devoid of nitrates
Aktiv komparator: Test drink
In this arm participants will receive nitrate-rich drink
Kosttilskud: Nitrate-rich drink
Nitrate is ingested, rather than rinsed and spit out
Andre navne:
  • Nitrate drink
Placebo komparator: Placebo drink
In this arm participants will receive placebo drink
Kosttilskud: Placebo
This mouth rinse is devoid of nitrates
Kosttilskud: Placebo
This drink is devoid of nitrates

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood pressure before and at regular intervals within the 24 hours after nitrate exposure.
Tidsramme: 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.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Plasma and salivary nitrate and nitrite levels before and after nitrate exposure.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Göteborg University

Efterforskere

  • Ledende efterforsker: Amina Basic, PhD, DDS, Göteborg University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. april 2026

Primær færdiggørelse (Anslået)

1. december 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

29. december 2025

Først indsendt, der opfyldte QC-kriterier

19. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. december 2025

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2025-02639-01

Plan for individuelle deltagerdata (IPD)

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