Examination of the Distribution of Nitrate Reducing Bacteria in the Human Oral Cavity

NCT03068962 | Unknown DMC

• 1 other identifier: 32/16
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

No Dental Disease; Non-smoking

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• Identify the major sites in the human oral cavity which contain nitrate reducing bacteria.

  1 year

Study Arms (3)

beetroot juice

EXPERIMENTAL

Rinse mouth with low nitrate Buxton mineral water followed by holding 10 ml of beetroot juice for 5 min,

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

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

Other: beetroot Juice; Other: antiseptic mouthwash then beetroot juice

Interventions

beetroot Juice OTHER

Beetroot Juice

antiseptic mouthwash then beetroot juice; beetroot juice

Buxton water OTHER

natural mineral water

low mineral water (Buxton water)

antiseptic mouthwash then beetroot juice OTHER

Chlorhexidine glocunate

antiseptic mouthwash then beetroot juice

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: 10 men and 10 women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female
• A signed consent form
• Age 18-55 years
• Non-smoking, healthy individuals
• BMI 18.5 - 30 kg/m2

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• University of Reading: lead

Study Sites (1)

Department of Food and Nutritional Sciences, University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 22414688 BACKGROUND

• Hord 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.

  PMID: 19439460 BACKGROUND

• Kapil 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.

  PMID: 23183324 BACKGROUND

• Lidder 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.

  PMID: 22882425 BACKGROUND

Study Officials

• Julie A Lovegrove, BSc, PhD

  University of Reading

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie A Lovegrove, BSc, PhD

CONTACT

0044118378; j.a.lovegrove@reading.ac.uk

Hayat S Alzahrani, MSc

CONTACT

07496966022; h.s.alzahrani@student.reading.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Human Nutrition

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 3, 2017
• Study Start: March 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: March 1, 2018
• Last Updated: March 3, 2017

Record last verified: 2017-02

Locations

GB (1)