Cardiovascular HealthMicrobioNCT03467061
The Effect of Dietary Nitrate on the Oral Microbiome
A study testing Nitrate-rich beetroot juice, Nitrate-depleted beetroot juice and Mouthwash in people with Cardiovascular Health and Identify Oral Bacteria Responsible for Nitrate Reduction, run by University of Exeter at 1 site in United Kingdom.
Trial summary
This study evaluates whether dietary manipulation of the oral microbiota modulates cardiovascular health through effects on nitric oxide bioavailability. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health, Identify Oral Bacteria Responsible for Nitrate Reduction
- What is being tested?
- Nitrate-rich beetroot juice, Nitrate-depleted beetroot juice and Mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jan 2018to 6 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Diabetes & Vascular Medicine Research Centre, Clinical Research Facility
Exeter, Devon
About this study
Official title: The Effect of Dietary Nitrate on the Oral Microbiota, Markers of Nitric Oxide Bioavailability and Cardiovascular Health in in Young and Older Adults
This study evaluates whether dietary manipulation of the oral microbiota modulates cardiovascular health through effects on nitric oxide bioavailability.
Read the detailed description
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.
- Being tested
- Nitrate-rich beetroot juice, Nitrate-depleted beetroot juice, Mouthwash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrate-rich beetroot juiceDietary supplement
concentrated beetroot juice
Nitrate-depleted beetroot juiceDietary supplement
concentrated beetroot juice
MouthwashOther
2 x 10 mL antibacterial mouthwash per day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Nitrate-rich beetroot juice | Active comparator | 2 x 70mL concentrated juice per day for 14 days Receives: Dietary Supplement: Nitrate-rich beetroot juice |
| Nitrate-depleted beetroot juice | Placebo comparator | 2 x 70mL concentrated juice per day for 14 days Receives: Dietary Supplement: Nitrate-depleted beetroot juice |
| Antibacterial mouthwash | Other | 2 x 10mL antibacterial mouthwash per day for 14 days Receives: Other: Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of nitrate -reducing bacteria
Change in total quantity of nitrate-reducing bacteria as measured by sequencing bacterial 16S rRNA genes
Measured: 14 days
Secondary outcomes (6)
Nitric oxide bioavailability - plasma nitrite
Change in nitrite concentration of plasma as measured by ozone-based chemiluminescence
Measured: 14 days
Nitric oxide bioavailability - salivary nitrite
Change in nitrite concentration of saliva as measured by ozone-based chemiluminescence
Measured: 14 days
Nitric oxide bioavailability - plasma nitrate
Change in nitrate concentration of plasma as measured by ozone-based chemiluminescence
Measured: 14 days
Nitric oxide bioavailability - salivary nitrate
Change in nitrate concentration of saliva as measured by ozone-based chemiluminescence
Measured: 14 days
Blood pressure
Change in systolic and diastolic BP
Measured: 14 days
Flow mediated dilation
Change in flow mediated dilation
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start10 Jan 2018
- Primary completion6 May 2021
- Study completion6 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular HealthStudies of the same condition, open and under way.
- 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew M Jones, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467061
- Sponsor's protocol ID
- 1718/14
- Acronym
- Microbio
- Status last verified
- May 2021
- First submitted
- 19 Dec 2017
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Nitrate on the Oral Microbiota, Markers of Nitric Oxide Bioavailability and Cardiovascular Health in in Young and Older Adults
- ClinicalTrials.gov ID
- NCT03467061
- Acronym / sponsor ID
- Microbio / 1718/14
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 6 May 2021 (actual)
- Study completion
- 6 May 2021 (actual)
- First posted
- 15 Mar 2018 (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.
This study evaluates whether dietary manipulation of the oral microbiota modulates cardiovascular health through effects on nitric oxide bioavailability.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nitrate-rich beetroot juice | Active comparator | Dietary Supplement: Nitrate-rich beetroot juice2 x 70mL concentrated juice per day for 14 days |
| Nitrate-depleted beetroot juice | Placebo comparator | Dietary Supplement: Nitrate-depleted beetroot juice2 x 70mL concentrated juice per day for 14 days |
| Antibacterial mouthwash | Other | Other: Mouthwash2 x 10mL antibacterial mouthwash per day for 14 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 beetroot juiceconcentrated beetroot juice | Dietary supplement | Nitrate-rich beetroot juice |
| Nitrate-depleted beetroot juiceconcentrated beetroot juice | Dietary supplement | Nitrate-depleted beetroot juice |
| Mouthwash2 x 10 mL antibacterial mouthwash per day for 14 days | Other | Antibacterial mouthwash |
Primary outcome
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
6 secondary outcomes
Nitric oxide bioavailability - plasma nitrite
Time frame: 14 days
Nitric oxide bioavailability - salivary nitrite
Time frame: 14 days
Nitric oxide bioavailability - plasma nitrate
Time frame: 14 days
Nitric oxide bioavailability - salivary nitrate
Time frame: 14 days
Blood pressure
Time frame: 14 days
Flow mediated dilation
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
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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. This study is not recruiting at the moment.
Andrew M Jones, PhD principal investigator
University of Exeter
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 beetroot juice, Nitrate-depleted beetroot juice and Mouthwash in people with Cardiovascular Health and Identify Oral Bacteria Responsible for Nitrate Reduction, run by University of Exeter at 1 site in United Kingdom.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 27 May 2021. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity of nitrate -reducing bacteria (time frame: 14 days). 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 27 May 2021.