Health TrialsbyHealthPanel

The Effects of Nitrate-Rich Mouthwash on Vascular Tone

ConditionBlood Pressure Regulation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGöteborg University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

≥18 years of age; and

clinic blood pressure <140/<90 mmHg.

Disqualifiers

hypertension;

systemic medication (other than the oral contraceptive pill);

antibiotic treatment within the last 3 months;

active smoking status and BMI > 30;

Trial design

Design model

Crossover

Treatments tested in this trial

  • Nitrate-rich mouth rinse

    Dietary supplement

    The oral cavity is rinsed with nitrate from mouth rinse, rather than ingested.

  • Nitrate-rich drink

    Dietary supplement

    Nitrate is ingested, rather than rinsed and spit out

  • Placebo

    Dietary supplement

    This mouth rinse is devoid of nitrates

  • Placebo

    Dietary supplement

    This drink is devoid of nitrates

Treatment groups

20 Participants
are divided into 4 treatment groups
Group A: Test mouth rinseExperimental treatment 1 intervention
Group B: Placebo mouth rinsePlacebo comparator 1 intervention
Group C: Test drinkActive comparator 1 intervention
Group D: Placebo drinkPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
2

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.

Time frame
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure

Secondary outcomes

1

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.

Time frame
Baseline (prior to nitrate exposure) and 1 hour after nitrate exposure.
2

Salivary pH levels at regular intervals.

Salivary pH will be measured using a pH-stick at regular intervals before and after nitrate exposure.

Time frame
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
3

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.

Time frame
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.
4

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.

Time frame
Baseline (prior to nitrate exposure) and during the 24 hours after nitrate exposure.

Other outcomes

Sponsors and contacts

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

Göteborg University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: