Blood Pressure RegulationNITRATONENCT07602764
The Effects of Nitrate-Rich Mouthwash on Vascular Tone
A study testing Nitrate-rich mouth rinse and Nitrate-rich drink in people with Blood Pressure Regulation, run by Göteborg University at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure Regulation
- What is being tested?
- Nitrate-rich mouth rinse and Nitrate-rich drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years of age; and
- clinic blood pressure <140/<90 mmHg.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Odontologen, University of Gothenburg
Gothenburg, Västra Götaland County, 41390
Amina Basic, DDS, PhD, +46766185930, amina.basic@gu.se
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Blood Pressure Regulation
- Being tested
- Nitrate-rich mouth rinse, Nitrate-rich drink, Placebo
- Keywords
- Nitrate reduction, Nitrate supplement, Blood pressure regulation, Plasma nitrate, Plasma nitrite, Saliva nitrate, Saliva nitrite, Mouth rinse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrate-rich mouth rinseDietary supplement
Also called Nitrate mouth rinse
The oral cavity is rinsed with nitrate from mouth rinse, rather than ingested.
Nitrate-rich drinkDietary supplement
Also called Nitrate drink
Nitrate is ingested, rather than rinsed and spit out
PlaceboDietary supplement
This mouth rinse is devoid of nitrates
PlaceboDietary supplement
This drink is devoid of nitrates
| Study group | Role | What they receive |
|---|---|---|
| Test mouth rinse | Experimental | In this arm participants will receive nitrate rich-mouth rinse Receives: Dietary Supplement: Nitrate-rich mouth rinse |
| Placebo mouth rinse | Placebo comparator | In this arm participants will receive placebo mouth rinse Receives: Dietary Supplement: Placebo |
| Test drink | Active comparator | In this arm participants will receive nitrate-rich drink Receives: Dietary Supplement: Nitrate-rich drink |
| Placebo drink | Placebo comparator | In this arm participants will receive placebo drink Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure before and at regular intervals within 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.
Measured: 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.
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.
Measured: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure
Secondary outcomes (8)
Plasma and salivary nitrate and nitrite levels before and 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.
Measured: Baseline (prior to nitrate exposure) and 1 hour after nitrate exposure.
Salivary pH levels at regular intervals.
Salivary pH will be measured using a pH-stick at regular intervals before and after nitrate exposure.
Measured: 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.
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.
Measured: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Salivary secretion rate before and 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.
Measured: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Relative abundance in cultivable oral microbial composition 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 (%).
Measured: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Absolute abundance in cultivable oral microbial composition 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).
Measured: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
PCR detection of specific oral bacterial 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.
Measured: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Oral microbial metabolite concentrations 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.
Measured: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Pressure RegulationStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amina Basic, Göteborg University
- Investigators
- Amina Basic, PhD, DDS, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602764
- Sponsor's protocol ID
- 2025-02639-01
- Other IDs
- 2025
- Acronym
- NITRATONE
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07602764
- Acronym / sponsor ID
- NITRATONE / 2025-02639-01
- Conditions
- Blood Pressure Regulation
- Keywords
- Nitrate reduction, Nitrate supplement, Blood pressure regulation, Plasma nitrate, Plasma nitrite, Saliva nitrate, Saliva nitrite, Mouth rinse
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test mouth rinse | Experimental | Dietary Supplement: Nitrate-rich mouth rinseIn this arm participants will receive nitrate rich-mouth rinse |
| Placebo mouth rinse | Placebo comparator | Dietary Supplement: PlaceboIn this arm participants will receive placebo mouth rinse |
| Test drink | Active comparator | Dietary Supplement: Nitrate-rich drinkIn this arm participants will receive nitrate-rich drink |
| Placebo drink | Placebo comparator | Dietary Supplement: PlaceboIn this arm participants will receive placebo drink |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥18 years of age; and
- clinic blood pressure <140/<90 mmHg.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrate-rich mouth rinseAlso: Nitrate mouth rinseThe oral cavity is rinsed with nitrate from mouth rinse, rather than ingested. | Dietary supplement | Test mouth rinse |
| Nitrate-rich drinkAlso: Nitrate drinkNitrate is ingested, rather than rinsed and spit out | Dietary supplement | Test drink |
| PlaceboThis mouth rinse is devoid of nitrates | Dietary supplement | Placebo mouth rinse |
| PlaceboThis drink is devoid of nitrates | Dietary supplement | Placebo drink |
Primary outcome
Blood pressure before and at regular intervals within the 24 hours after nitrate exposure.
Time frame: 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.
Oral nitrite production before and at regular intervals within the 24 hours after nitrate exposure.
Time frame: 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.
8 secondary outcomes
Plasma and salivary nitrate and nitrite levels before and after nitrate exposure.
Time frame: Baseline (prior to nitrate exposure) and 1 hour after nitrate exposure.
Salivary pH levels at regular intervals.
Time frame: 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.
Time frame: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Salivary secretion rate before and after nitrate exposure.
Time frame: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Relative abundance in cultivable oral microbial composition after nitrate exposure
Time frame: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Absolute abundance in cultivable oral microbial composition after nitrate exposure
Time frame: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
PCR detection of specific oral bacterial after nitrate exposure
Time frame: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Oral microbial metabolite concentrations after nitrate exposure
Time frame: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amina Basic, PhD, DDS principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrate-rich mouth rinse and Nitrate-rich drink in people with Blood Pressure Regulation, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simeon KB Mavropoulos, DDS, MSc (+46766185930, simeon.mavropoulos@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure before and at regular intervals within the 24 hours after nitrate exposure. (time frame: Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.