The Effect of Dietary Nitrate on the Oral Microbiome

NCT ID: NCT03467061

Last Updated: 2021-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2021-05-06

Brief Summary

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

Detailed Description

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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.

Conditions

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Cardiovascular Health Identify Oral Bacteria Responsible for Nitrate Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nitrate-rich beetroot juice

2 x 70mL concentrated juice per day for 14 days

Group Type ACTIVE_COMPARATOR

Nitrate-rich beetroot juice

Intervention Type DIETARY_SUPPLEMENT

concentrated beetroot juice

Nitrate-depleted beetroot juice

2 x 70mL concentrated juice per day for 14 days

Group Type PLACEBO_COMPARATOR

Nitrate-depleted beetroot juice

Intervention Type DIETARY_SUPPLEMENT

concentrated beetroot juice

Antibacterial mouthwash

2 x 10mL antibacterial mouthwash per day for 14 days

Group Type OTHER

Mouthwash

Intervention Type OTHER

2 x 10 mL antibacterial mouthwash per day for 14 days

Interventions

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Nitrate-rich beetroot juice

concentrated beetroot juice

Intervention Type DIETARY_SUPPLEMENT

Nitrate-depleted beetroot juice

concentrated beetroot juice

Intervention Type DIETARY_SUPPLEMENT

Mouthwash

2 x 10 mL antibacterial mouthwash per day for 14 days

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Exeter

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew M Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Exeter

Locations

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Diabetes & Vascular Medicine Research Centre, Clinical Research Facility

Exeter, Devon, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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1718/14

Identifier Type: -

Identifier Source: org_study_id

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