Examination of the Distribution of Nitrate Reducing Bacteria in the Human Oral Cavity (REBOC)
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|ClinicalTrials.gov Identifier: NCT03068962|
Recruitment Status : Unknown
Verified February 2017 by Julie Lovegrove, University of Reading.
Recruitment status was: Not yet recruiting
First Posted : March 3, 2017
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|No Dental Disease Non-smoking||Other: beetroot Juice Other: Buxton water Other: antiseptic mouthwash then beetroot juice||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Examination of the Distribution of Nitrate Reducing Bacteria in the Human Oral Cavity|
|Estimated Study Start Date :||March 2017|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||March 2018|
Experimental: beetroot juice
Rinse mouth with low nitrate Buxton mineral water followed by holding 10 ml of beetroot juice for 5 min,
Other: beetroot Juice
Experimental: low mineral water (Buxton water)
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
Other: Buxton water
natural mineral water
Experimental: antiseptic mouthwash then beetroot juice
Rinse with antiseptic mouthwash before holding 10 ml of beetroot juice in the mouth for 5 min
Other: beetroot Juice
Other: antiseptic mouthwash then beetroot juice
- 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.
- Identify the major sites in the human oral cavity which contain nitrate reducing bacteria. [ Time Frame: 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068962
|Contact: Julie A Lovegrove, BSc, PhD||0044118378 ext firstname.lastname@example.org|
|Contact: Hayat S Alzahrani, MScemail@example.com|
|Department of Food and Nutritional Sciences, University of Reading|
|Reading, Berkshire, United Kingdom, RG6 6AP|
|Contact: Julie A Lovegrove, BSc, PhD 0044118 378 ext 5361 firstname.lastname@example.org|
|Contact: Hayat Alzahrani, MSc email@example.com|
|Principal Investigator: Julie A Lovegrove, BSc, PhD|
|Sub-Investigator: Hayat S Alzahrani, MSc|
|Sub-Investigator: Kim G Jackson, BSc, PhD|
|Sub-Investigator: Ditte A Hobbs, BSc, PhD|
|Sub-Investigator: Gemma E Walton, BSc, PhD|
|Principal Investigator:||Julie A Lovegrove, BSc, PhD||University of Reading|