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Clinical Trials/NCT03467061
NCT03467061CompletedNot Applicable

The Effect of Dietary Nitrate on the Oral Microbiota, Markers of Nitric Oxide Bioavailability and Cardiovascular Health in in Young and Older Adults

University of Exeter1 site in 1 country101 target enrollmentStarted: January 10, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
101
Locations
1
Primary Endpoint
Quantity of nitrate -reducing bacteria

Study Overview

Brief Summary

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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 Outcomes

  • Nitric oxide bioavailability - salivary nitrite(14 days)
  • Nitric oxide bioavailability - plasma nitrate(14 days)
  • Blood pressure(14 days)
  • Nitric oxide bioavailability - salivary nitrate(14 days)
  • Flow mediated dilation(14 days)
  • Nitric oxide bioavailability - plasma nitrite(14 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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