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Short-term effects on blood pressure of reducing nitrate metabolism using antibacterial mouthwash in treated hypertensive individuals

Short-term effects on blood pressure of reducing nitrate metabolism using antibacterial mouthwash in treated hypertensive individuals

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000417785
Enrollment
15
Registered
2013-04-15
Start date
2013-02-01
Completion date
2013-09-27
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There is now consistent and convincing evidence that dietary inorganic nitrate plays an important role in the physiological control of blood pressure. Clinical trials have established that an increase in nitrate intake, either from supplements or vegetables, results in a dose-related decrease in blood pressure in healthy normotensive individuals. This trial will address the importance of nitrate reduction by bacteria in the mouth for the control of level of blood pressure in treated hypertensive individuals.

Interventions

A randomised, controlled, cross-over designed trial will be performed. Each participant will complete 2 intervention periods of 3 days each in random order. These will be separated by a 10 to 12 day washout period. The 3 day intervention periods will correspond to use of either an antibacterial mouth wash (20 ml with 2mg/mL chlorhexidine gluconate) or plain tap water (20 ml) to rinse the mouth after brushing teeth. This will be performed twice daily: in the morning after breakfast; and in the ev

A randomised, controlled, cross-over designed trial will be performed. Each participant will complete 2 intervention periods of 3 days each in random order. These will be separated by a 10 to 12 day washout period. The 3 day intervention periods will correspond to use of either an antibacterial mouth wash (20 ml with 2mg/mL chlorhexidine gluconate) or plain tap water (20 ml) to rinse the mouth after brushing teeth. This will be performed twice daily: in the morning after breakfast; and in the evening after dinner. On each occasion participants will wash their mouth with 20 ml of mouthwash or plain tap water by swishing and gargling for 30 seconds, and then spitting out. During one of the 3 day periods participants will use the mouthwash and the other 3 day period they will use plain tap water. The order of the two periods will be random. Adherence to use of the moutwash/water will be established by participant diaries and measurement of nitrate reduction in the mouth. Throughout each 3 day intervention period participants will be asked to measure their blood pressure at home each day in the morning (shortly after waking), during the afternoon (at a convenient time) and during the evening (shortly before going to sleep). Three home blood pressure measurements, with a 1 minute interval between measurements, will be performed at each time each day (a total of nine blood pressure measurements each day). Participants will be provided with instructions regarding these measurements. The aim is to determine if reducing nitrate metabolism to nitrite (the precursor of NO) using antibacterial mouthwash will alter blood pressure. The antibacterial mouth wash can temporarily reduce the number of bacterial on the tongue that can reduce nitrate to nitrite. On the morning of day 4, at the end of each 3 day intervention period, (visit 2 and visit 3) participants will visit attend the School of Medicine and Pharmacology at the Royal Perth Hospital once for approximately 1.5 hours. Participants do not need to fast, but are asked to have the same breakfast meal prior to each visit. Prescribed medication will be taken as usual. At each of the two visits participants will: *Have a 15 ml fasting blood sample (approximately 3 teaspoons) taken to measure the metabolism of the nitrate, and to measure biochemical factors related to blood pressure. * Provide a 5 minute saliva sample. *Have the nitrate reduction by the bacteria in the mouth tested. This will involve holding a water and a nitrate solution in the mouth for 5 minutes each, before spitting them into a collection vessel. *Have arterial (blood vessel) stiffness measured using the CR2000 device. * Bring in the home blood pressure monitor for downloading of blood pressure measurements from the previous 3 days.

Sponsors

The University of Western Australia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
50 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Men and women will be aged between 50 and 70 years * Regular use of at least one antihypertensive medication for elevated blood pressure * Clinic/office systolic blood pressure will be >120 mmHg

Exclusion criteria

* Use of more than 3 antihypertensive medications * A change in antihypertensive medication within the past 1 month * Inability to attend clinic/office visits * Clinic/office systolic blood pressure greater than 160 mm Hg or less than 120 mm Hg; or diastolic blood pressure greater than 100 mm Hg; * Use of antibiotics (within previous 1 months); * current or recent (<6 months) smoking; * body mass index < 18 or > 35 kg/m2; * current cardiovascular or peripheral vascular disease, or diagnosed diabetes, or history of a cardiovascular event; * a psychiatric illness, or presence of other major illnesses such as cancer; * current or recent (within previous 6 months) significant weight loss or gain (> 6% of body weight); * alcohol intake > 210 g per wk for women and > 280 g per wk for men; * pregnant or lactating women; * inability or unwillingness to consume beverages provided.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026