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Completed

NCT Number: NCT03467061

The Effect of Dietary Nitrate on the Oral Microbiome

This study evaluates whether dietary manipulation of the oral microbiota modulates cardiovascular health through effects on nitric oxide bioavailability.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes & Vascular Medicine Research Centre, Clinical Research Facility

Exeter, Devon, United Kingdom

About this study

Nitric oxide is an important molecule for human health because it controls blood flow and blood pressure. With aging, our ability to make nitric oxide gets worse and our blood pressure tends to increase. We can help the body produce more nitric oxide by supplementing the diet with vegetables, such as beetroot juice, which contains high amounts of nitrate. This has been shown to improve blood flow and blood pressure. The bacteria inside our mouths play an important role in helping convert the ingested nitrate to nitric oxide. The reason for this study is to find out whether there are differences in oral bacteria between young and older adults, and how the oral bacterial community and blood flow and blood pressure might change when diet is supplemented with natural, nitrate-rich beetroot juice and when we use antibacterial mouthwash. This study will help us understand how the bacteria inside our mouths might be useful for keeping us healthy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy young (18-30 yr) and older adults (65-80 yr)
  • Male and female
  • Willing to undergo the experiments as detailed in the informed consent documentation
  • Willing and capable of providing written, informed consent.

Exclusion criteria

  • Individuals receiving medication for pulmonary, cardiovascular, or metabolic conditions, ulcerative colitis or renal disease
  • Having an active oral disease or dentures
  • Having resting BP >140/90 mmHg
  • Having used antibiotics within 3 months
  • Lacking willingness or capacity to give informed consent.

Treatment and study plan

Nitrate-rich beetroot Juice

Dietary Supplement

concentrated beetroot juice

Nitrate-depleted beetroot juice

Dietary Supplement

concentrated beetroot juice

mouthwash

Other

2 x 10 mL antibacterial mouthwash per day for 14 days

Primary outcomes

  1. Quantity of nitrate -reducing bacteria

    Time frame: 14 days

    Change in total quantity of nitrate-reducing bacteria as measured by sequencing bacterial 16S rRNA genes

Secondary outcomes

  1. Nitric oxide bioavailability - plasma nitrite

    Time frame: 14 days

    Change in nitrite concentration of plasma as measured by ozone-based chemiluminescence

  2. Nitric oxide bioavailability - salivary nitrite

    Time frame: 14 days

    Change in nitrite concentration of saliva as measured by ozone-based chemiluminescence

  3. Nitric oxide bioavailability - plasma nitrate

    Time frame: 14 days

    Change in nitrate concentration of plasma as measured by ozone-based chemiluminescence

  4. Nitric oxide bioavailability - salivary nitrate

    Time frame: 14 days

    Change in nitrate concentration of saliva as measured by ozone-based chemiluminescence

  5. Blood pressure

    Time frame: 14 days

    Change in systolic and diastolic BP

  6. Flow mediated dilation

    Time frame: 14 days

    Change in flow mediated dilation

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Registry information

Official study title

The Effect of Dietary Nitrate on the Oral Microbiota, Markers of Nitric Oxide Bioavailability and Cardiovascular Health in in Young and Older Adults

Acronym: Microbio

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 15, 2018
Registry last updated
May 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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