NCT03467061

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2017

Completed
22 days until next milestone

Study Start

First participant enrolled

January 10, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2021

Completed
Last Updated

May 27, 2021

Status Verified

May 1, 2021

Enrollment Period

3.3 years

First QC Date

December 19, 2017

Last Update Submit

May 26, 2021

Conditions

Cardiovascular HealthIdentify Oral Bacteria Responsible for Nitrate Reduction

Outcome Measures

Primary Outcomes (1)

  • Quantity of nitrate -reducing bacteria

    Change in total quantity of nitrate-reducing bacteria as measured by sequencing bacterial 16S rRNA genes

    14 days

Secondary Outcomes (6)

  • Nitric oxide bioavailability - plasma nitrite

    14 days

  • Nitric oxide bioavailability - salivary nitrite

    14 days

  • Nitric oxide bioavailability - plasma nitrate

    14 days

  • Nitric oxide bioavailability - salivary nitrate

    14 days

  • Blood pressure

    14 days

  • +1 more secondary outcomes

Study Arms (3)

Nitrate-rich beetroot juice

ACTIVE COMPARATOR

2 x 70mL concentrated juice per day for 14 days

Dietary Supplement: Nitrate-rich beetroot juice

Nitrate-depleted beetroot juice

PLACEBO COMPARATOR

2 x 70mL concentrated juice per day for 14 days

Dietary Supplement: Nitrate-depleted beetroot juice

Antibacterial mouthwash

OTHER

2 x 10mL antibacterial mouthwash per day for 14 days

Other: Mouthwash

Interventions

Nitrate-rich beetroot juiceDIETARY_SUPPLEMENT

concentrated beetroot juice

Nitrate-rich beetroot juice
Nitrate-depleted beetroot juiceDIETARY_SUPPLEMENT

concentrated beetroot juice

Nitrate-depleted beetroot juice
MouthwashOTHER

2 x 10 mL antibacterial mouthwash per day for 14 days

Antibacterial mouthwash

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes & Vascular Medicine Research Centre, Clinical Research Facility

Exeter, Devon, United Kingdom

Location

MeSH Terms

Interventions

Mouthwashes

Intervention Hierarchy (Ancestors)

Biomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesCosmeticsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Andrew M Jones, PhD

    University of Exeter

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2017

First Posted

March 15, 2018

Study Start

January 10, 2018

Primary Completion

May 6, 2021

Study Completion

May 6, 2021

Last Updated

May 27, 2021

Record last verified: 2021-05

Locations

GB(1)