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The role of oral bacteria on blood nitrite concentration following a beverage high in inorganic nitrate (beetroot juice)

The role of nitrate reductase bacteria on plasma nitrite concentration following an acute oral inorganic nitrate dose in healthy volunteers

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000123448
Enrollment
75
Registered
2016-02-03
Start date
2017-03-06
Completion date
2017-12-10
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

This study seeks to expand on previous research, which found that the consumption inorganic nitrate can significantly lower blood pressure (BP) via increasing the availability of nitric oxide (NO) within the circulation. Nitrate supplementation increases NO in a two-step process 1) Nitrate to nitrite and 2) Nitrite to NO. Step one is highly dependent on oral bacteria to facilitate the reduction of nitrate to nitrite within the saliva. However, the magnitude of this conversion appears to vary from person to person and even potentially from day to day in the same individual. This variability is not completely understood but appears to be facilitated by the amount and make-up of oral bacteria in the mouth., As a result, the primary aim of this study is to determine the relationship between the type and amount of oral bacteria and the concentration of nitrite in the plasma following a high inorganic nitrate beverage (beetroot Juice). Observing the relationship between the change in plasma nitrite concentration and the change in brachial artery blood pressure following a high inorganic nitrate beverage (beetroot Juice) is a secondary aim of the study. Participants will complete only one testing visit. Upon arrival, baseline data collection will include blood pressure, a saliva sample (to identify particular markers on the cells and pH of the oral cavity which may influence bacteria in the mouth), tongue swab (to identify the present oral bacteria) and a blood draw (for resting plasma nitrate and nitrite levels) will be taken. Participants will then be asked to consume a beverage high in inorganic nitrate (beetroot juice). Two and a half hours following supplementation participants will undergo repeat testing measures including another blood draw and BP. To our knowledge, no other trial has used this particular model when examining the role of oral bacteria in inorganic nitrate to nitrite conversion and therefore the current study is a pilot study to help inform us of sample size requirements in a heterogeneous population and whether particular bacterial species are more or less relevant. For patients with cardiovascular disease, nitrate supplementation provides a potential alternative source of NO, which we know they often cannot produce the same as healthy subjects do. The results of this study may contribute to our understanding of this process that could be used as an intervention for blood pressure in the future.

Interventions

Participants will consume two 70mL bottles of beetroot juice containing a total of 8.4mmol of nitrate. (BEET IT shot, James White Drinks, Ipswich, UK). The beetroot juice will be consumed as a one off, during the testing visit, in the presence of the investigator.

Sponsors

Victoria University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

Male and Female Age: 18-70 years Non-Smoker (or not smoked for the last 3 months) Resting SBP between 90 and 180mmHg Resting DBP between 60 and 110mmHg BMI under 30kg.m2

Exclusion criteria

Informed they have a dental cavity, dental surgery or oral disease in the last 3 months Currently taking antibiotics Currently taking Proton Pump Inhibitor medications ie. Omeprazole Have been diagnosed with a Cardiovascular Disease

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026