No Dental DiseaseREBOCNCT03068962
Examination of the Distribution of Nitrate Reducing Bacteria in the Human Oral Cavity
A study testing beetroot Juice, Buxton water and antiseptic mouthwash then beetroot juice in people with No Dental Disease and Non-smoking, run by University of Reading at 1 site in United Kingdom.
Trial summary
Dietary nitrate have been shown to have health benefits including lowering blood pressure (Hobbs et al, 2012), improving endothelial function and inhibiting platelet aggregation in healthy humans (Lidder \& Webb, 2013). The main sources of dietary nitrate in the human diet are vegetables such as beetroot. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- No Dental Disease, Non-smoking
- What is being tested?
- beetroot Juice, Buxton water and antiseptic mouthwash then beetroot juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2017to Mar 2018
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female
- A signed consent form
- Age 18-55 years
- Non-smoking, healthy individuals
- BMI 18.5 - 30 kg/m2
Who cannot join
- Diagnosed with a chronic illness
- Individuals with food allergies or allergies to medicated mouthwash or ingredients in the oral products
- Requirements to take long-term medication active on the oral cavity or taken antibiotics within the last 3 months
- Current diagnosis of dental caries, gingivitis, or periodontal disease or chronic oral complaints or Existing oral pathology (active caries lesions and/or periodontal disease; mucosal lesions; poor occlusion)
- Current smoker (regular and electronic cigarettes and cigars)
- Participating in a dietary intervention study.
Show all 11Show fewer
- Excessive alcohol consumption (> 21 units/wk male, >14 units/wk female)
- Females who are pregnant or lactating
- Reduced salivary flow (unstimulated flow less than 0.1 ml/min);
- less than four natural (enamel) buccal surfaces of upper molars available;
- presence of fixed or removable oral appliances (e.g., dentures, orthodontic wires)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, RG6 6AP
Julie A Lovegrove, BSc, PhD, 0044118 378 ext. 5361, j.a.lovegrove@reading.ac.uk
Hayat Alzahrani, MSc, h.s.alzahrani@student.reading.ac.uk
About this study
Dietary nitrate have been shown to have health benefits including lowering blood pressure (Hobbs et al, 2012), improving endothelial function and inhibiting platelet aggregation in healthy humans (Lidder \& Webb, 2013). The main sources of dietary nitrate in the human diet are vegetables such as beetroot. Nitrates are converted to nitrites then nitric oxide (NO), following their reduction by commensal oral bacteria and those residing in the gastrointestinal tract (Hord, Tang, \& Bryan, 2009; Lidder \& Webb, 2013). A recent study has shown following elimination of oral bacteria by the use of a chlorhexidine based antiseptic mouthwash, the conversion of nitrate to nitrite is prevented and this is accompanied by a statistically significant increase in blood pressure in normotensive subjects (Kapil et al., 2013). To date, very few studies have investigated the potential role of these oral bacteria in control of blood pressure and if there are any inter and intra-individual differences in bacterial composition.
Read the detailed description
Volunteers will be provided with an outline of the study and asked to complete a medical and lifestyle questionnaire (in person, email or over the phone). Potentially suitable participants will be identified and asked to attend a screening session during which the study will be explained in more detail before a consent form is signed. Anthropometric measurements will then be taken such as weight, height and blood pressure. Subjects who meet the inclusion criteria will be invited to a further screening session during which time a dentist will check for dental diseases (e.g. current dental cavities or periodontal infection). The oral bacteria samples will be collected in the morning on site at the Department of Food and Nutritional Sciences (Hugh Sinclair Unit of Human Nutrition) on four visit days (including screening visit).On the day before each study visit the volunteers will need to have a low nitrate diet, refrain from strenuous exercise and alcohol, and drink low nitrate mineral water. They will be required to fast overnight and only drink water. In the morning, they will be asked to refrain from brushing their teeth or using mouthwash.
When they arrive in the unit in the fasted state, they will then be randomised to one of three treatments:
- Rinse mouth with low nitrate Buxton mineral water followed by holding 10 ml of beetroot juice (~6 mmol nitrate) for 5 min,
- Rinse mouth with low nitrate Buxton mineral water followed by holding 10 ml of low nitrate mineral water in the mouth for 5 min or
- Rinse with antiseptic mouthwash before holding 10 ml of beetroot juice in the mouth for 5 min.
After 5 mins of holding low nitrate water or beetroot juice in the mouth, they will then spit the whole mouth rinse into a sterile ice-chilled tube.
To evaluate the nitrate reduction in different areas of the oral cavity, the researchers will put filter paper squares which have been soaked in water or beetroot juice in different areas of their mouth (rear, mid and front tongue, tooth surface, buccal surface, hard palate, and sublingual). Volunteers will be required to keep the filter papers in their mouth for 90 seconds before they are removed.
Finally, the oral bacteria will be collected from the 7 sites by sliding a piece of sterile oral floss between the 2 back molars and by swabbing a micro brush along the buccal cervical margin of premolars and rear, mid, front tongue. Saliva will be obtained using a sterile cotton swab. All samples will be placed into sterile tubes (Eppendorfs). Mouth rinse will be collected in sterile ice-chilled Falcon tubes.
Volunteers will then be provided with a light breakfast before they leave the unit. Facilities will be available for participants to brush their teeth before they leave the clinical unit.
The study visits will be separated by at least 1 week.
- Conditions
- No Dental Disease, Non-smoking
- Being tested
- beetroot Juice, Buxton water, antiseptic mouthwash then beetroot juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beetroot JuiceOther
Beetroot Juice
Buxton waterOther
natural mineral water
antiseptic mouthwash then beetroot juiceOther
Chlorhexidine glocunate
| Study group | Role | What they receive |
|---|---|---|
| beetroot juice | Experimental | Rinse mouth with low nitrate Buxton mineral water followed by holding 10 ml of beetroot juice for 5 min, Receives: Other: beetroot Juice |
| low mineral water (Buxton water) | Experimental | Rinse mouth with low nitrate Buxton mineral water followed by holding 10 ml of low nitrate mineral water in the mouth for 5 min or Receives: Other: Buxton water |
| antiseptic mouthwash then beetroot juice | Experimental | Rinse with antiseptic mouthwash before holding 10 ml of beetroot juice in the mouth for 5 min Receives: Other: beetroot Juice; Other: antiseptic mouthwash then beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral bacteria sample will be collected to Identification of nitrate reductase-positive bacteria in the oral cavity and capacity to reduce dietary nitrate
In vitro method will be used to isolate the nitrate reducing bacteria then 16SrDNA sequencing will be used to identify the species of these bacteria.
Measured: 1 year
Secondary outcomes (1)
Identify the major sites in the human oral cavity which contain nitrate reducing bacteria.
filter paper will be put in different sites around the oral cavity in human trial and then removed before analysis using chemiluminescence to determine nitrate and nitrite concentrations.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study startMar 2017 (estimated)
- Primary completionSep 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for No Dental DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Lovegrove, University of Reading
- Investigators
- Julie A Lovegrove, BSc, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068962
- Sponsor's protocol ID
- 32/16
- Acronym
- REBOC
- Status last verified
- Feb 2017
- First submitted
- 22 Feb 2017
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hobbs DA, Kaffa N, George TW, Methven L, Lovegrove JA. Blood pressure-lowering effects of beetroot juice and novel beetroot-enriched bread products in normotensive male subjects. Br J Nutr. 2012 Dec 14;108(11):2066-74. doi: 10.1017/S0007114512000190. Epub 2012 Mar 14.
PubMed 22414688Hord NG, Tang Y, Bryan NS. Food sources of nitrates and nitrites: the physiologic context for potential health benefits. Am J Clin Nutr. 2009 Jul;90(1):1-10. doi: 10.3945/ajcn.2008.27131. Epub 2009 May 13.
PubMed 19439460Kapil V, Haydar SM, Pearl V, Lundberg JO, Weitzberg E, Ahluwalia A. Physiological role for nitrate-reducing oral bacteria in blood pressure control. Free Radic Biol Med. 2013 Feb;55:93-100. doi: 10.1016/j.freeradbiomed.2012.11.013. Epub 2012 Nov 23.
PubMed 23183324Lidder S, Webb AJ. Vascular effects of dietary nitrate (as found in green leafy vegetables and beetroot) via the nitrate-nitrite-nitric oxide pathway. Br J Clin Pharmacol. 2013 Mar;75(3):677-96. doi: 10.1111/j.1365-2125.2012.04420.x.
PubMed 22882425
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Distribution of Nitrate Reducing Bacteria in the Human Oral Cavity
- ClinicalTrials.gov ID
- NCT03068962
- Acronym / sponsor ID
- REBOC / 32/16
- Conditions
- No Dental Disease, Non-smoking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- Mar 2017 (estimated)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 3 Mar 2017 (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.
Dietary nitrate have been shown to have health benefits including lowering blood pressure (Hobbs et al, 2012), improving endothelial function and inhibiting platelet aggregation in healthy humans (Lidder \& Webb, 2013). The main sources of dietary nitrate in the human diet are vegetables such as beetroot. Nitrates are converted to nitrites then nitric oxide (NO), following their reduction by commensal oral bacteria and those residing in the gastrointestinal tract (Hord, Tang, \& Bryan, 2009; Lidder \& Webb, 2013). A recent study has shown following elimination of oral bacteria by the use of a chlorhexidine based antiseptic mouthwash, the conversion of nitrate to nitrite is prevented and this is accompanied by a statistically significant increase in blood pressure in normotensive subjects (Kapil et al., 2013). To date, very few studies have investigated the potential role of these oral bacteria in control of blood pressure and if there are any inter and intra-individual differences in bacterial composition.
Detailed description
Volunteers will be provided with an outline of the study and asked to complete a medical and lifestyle questionnaire (in person, email or over the phone). Potentially suitable participants will be identified and asked to attend a screening session during which the study will be explained in more detail before a consent form is signed. Anthropometric measurements will then be taken such as weight, height and blood pressure. Subjects who meet the inclusion criteria will be invited to a further screening session during which time a dentist will check for dental diseases (e.g. current dental cavities or periodontal infection). The oral bacteria samples will be collected in the morning on site at the Department of Food and Nutritional Sciences (Hugh Sinclair Unit of Human Nutrition) on four visit days (including screening visit).On the day before each study visit the volunteers will need to have a low nitrate diet, refrain from strenuous exercise and alcohol, and drink low nitrate mineral water. They will be required to fast overnight and only drink water. In the morning, they will be asked to refrain from brushing their teeth or using mouthwash.
When they arrive in the unit in the fasted state, they will then be randomised to one of three treatments:
- Rinse mouth with low nitrate Buxton mineral water followed by holding 10 ml of beetroot juice (~6 mmol nitrate) for 5 min,
- Rinse mouth with low nitrate Buxton mineral water followed by holding 10 ml of low nitrate mineral water in the mouth for 5 min or
- Rinse with antiseptic mouthwash before holding 10 ml of beetroot juice in the mouth for 5 min.
After 5 mins of holding low nitrate water or beetroot juice in the mouth, they will then spit the whole mouth rinse into a sterile ice-chilled tube.
To evaluate the nitrate reduction in different areas of the oral cavity, the researchers will put filter paper squares which have been soaked in water or beetroot juice in different areas of their mouth (rear, mid and front tongue, tooth surface, buccal surface, hard palate, and sublingual). Volunteers will be required to keep the filter papers in their mouth for 90 seconds before they are removed.
Finally, the oral bacteria will be collected from the 7 sites by sliding a piece of sterile oral floss between the 2 back molars and by swabbing a micro brush along the buccal cervical margin of premolars and rear, mid, front tongue. Saliva will be obtained using a sterile cotton swab. All samples will be placed into sterile tubes (Eppendorfs). Mouth rinse will be collected in sterile ice-chilled Falcon tubes.
Volunteers will then be provided with a light breakfast before they leave the unit. Facilities will be available for participants to brush their teeth before they leave the clinical unit.
The study visits will be separated by at least 1 week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| beetroot juice | Experimental | Other: beetroot JuiceRinse mouth with low nitrate Buxton mineral water followed by holding 10 ml of beetroot juice for 5 min, |
| low mineral water (Buxton water) | Experimental | Other: Buxton waterRinse mouth with low nitrate Buxton mineral water followed by holding 10 ml of low nitrate mineral water in the mouth for 5 min or |
| antiseptic mouthwash then beetroot juice | Experimental | Other: beetroot Juice, Other: antiseptic mouthwash then beetroot juiceRinse with antiseptic mouthwash before holding 10 ml of beetroot juice in the mouth for 5 min |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female
- A signed consent form
- Age 18-55 years
- Non-smoking, healthy individuals
- BMI 18.5 - 30 kg/m2
Key exclusion criteria (11 listed)
- Diagnosed with a chronic illness
- Individuals with food allergies or allergies to medicated mouthwash or ingredients in the oral products
- Requirements to take long-term medication active on the oral cavity or taken antibiotics within the last 3 months
- Current diagnosis of dental caries, gingivitis, or periodontal disease or chronic oral complaints or Existing oral pathology (active caries lesions and/or periodontal disease; mucosal lesions; poor occlusion)
- Current smoker (regular and electronic cigarettes and cigars)
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 |
|---|---|---|
| beetroot JuiceBeetroot Juice | Other | antiseptic mouthwash then beetroot juice, beetroot juice |
| Buxton waternatural mineral water | Other | low mineral water (Buxton water) |
| antiseptic mouthwash then beetroot juiceChlorhexidine glocunate | Other | antiseptic mouthwash then beetroot juice |
Primary outcome
oral bacteria sample will be collected to Identification of nitrate reductase-positive bacteria in the oral cavity and capacity to reduce dietary nitrate
Time frame: 1 year
In vitro method will be used to isolate the nitrate reducing bacteria then 16SrDNA sequencing will be used to identify the species of these bacteria.
1 secondary outcome
Identify the major sites in the human oral cavity which contain nitrate reducing bacteria.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Background: PubMed 22414688Hobbs DA, Kaffa N, George TW, Methven L, Lovegrove JA. Blood pressure-lowering effects of beetroot juice and novel beetroot-enriched bread products in normotensive male subjects. Br J Nutr. 2012 Dec 14;108(11):2066-74. doi: 10.1017/S0007114512000190. Epub 2012 Mar 14.
- Background: PubMed 19439460Hord NG, Tang Y, Bryan NS. Food sources of nitrates and nitrites: the physiologic context for potential health benefits. Am J Clin Nutr. 2009 Jul;90(1):1-10. doi: 10.3945/ajcn.2008.27131. Epub 2009 May 13.
- Background: PubMed 23183324Kapil V, Haydar SM, Pearl V, Lundberg JO, Weitzberg E, Ahluwalia A. Physiological role for nitrate-reducing oral bacteria in blood pressure control. Free Radic Biol Med. 2013 Feb;55:93-100. doi: 10.1016/j.freeradbiomed.2012.11.013. Epub 2012 Nov 23.
- Background: PubMed 22882425Lidder S, Webb AJ. Vascular effects of dietary nitrate (as found in green leafy vegetables and beetroot) via the nitrate-nitrite-nitric oxide pathway. Br J Clin Pharmacol. 2013 Mar;75(3):677-96. doi: 10.1111/j.1365-2125.2012.04420.x.
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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.
Julie A Lovegrove, BSc, PhD principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing beetroot Juice, Buxton water and antiseptic mouthwash then beetroot juice in people with No Dental Disease and Non-smoking, run by University of Reading 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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 3 Mar 2017. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie A Lovegrove, BSc, PhD (0044118378 ext. 6418, j.a.lovegrove@reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral bacteria sample will be collected to Identification of nitrate reductase-positive bacteria in the oral cavity and capacity to reduce dietary nitrate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03068962, which also lists 4 linked publications.
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 3 Mar 2017.