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The Effect of Dietary Nitrate on the Oral Microbiome (Microbio)

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ClinicalTrials.gov Identifier: NCT03467061
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
University of Exeter

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

Condition or disease Intervention/treatment Phase
Cardiovascular Health Identify Oral Bacteria Responsible for Nitrate Reduction Dietary Supplement: Nitrate-rich beetroot juice Dietary Supplement: Nitrate-depleted beetroot juice Other: Mouthwash Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
Active Comparator: Nitrate-rich beetroot juice
2 x 70mL concentrated juice per day for 14 days
Dietary Supplement: Nitrate-rich beetroot juice
concentrated beetroot juice

Placebo Comparator: Nitrate-depleted beetroot juice
2 x 70mL concentrated juice per day for 14 days
Dietary Supplement: Nitrate-depleted beetroot juice
concentrated beetroot juice

Antibacterial mouthwash
2 x 10mL antibacterial mouthwash per day for 14 days
Other: Mouthwash
2 x 10 mL antibacterial mouthwash per day for 14 days




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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): NCT03467061


Contacts
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Contact: Christopher Thompson, PhD +44 (0) 1392 722893 c.thompson3@exeter.ac.uk
Contact: Anni Vanhatalo, PhD a.vanhatalo@exeter.ac.uk

Locations
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United Kingdom
Diabetes & Vascular Medicine Research Centre, Clinical Research Facility Recruiting
Exeter, Devon, United Kingdom
Contact: Michelle Hudson    +44 (0) 1392 40 8183    M.Hudson@exeter.ac.uk   
Sponsors and Collaborators
University of Exeter
Investigators
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Principal Investigator: Andrew M Jones, PhD University of Exeter

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Responsible Party: University of Exeter
ClinicalTrials.gov Identifier: NCT03467061     History of Changes
Other Study ID Numbers: 1718/14
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents