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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03467061
Other study ID # 1718/14
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2018
Est. completion date May 6, 2021

Study information

Verified date May 2021
Source University of Exeter
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date May 6, 2021
Est. primary completion date May 6, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Nitrate-rich beetroot juice
concentrated beetroot juice
Nitrate-depleted beetroot juice
concentrated beetroot juice
Other:
Mouthwash
2 x 10 mL antibacterial mouthwash per day for 14 days

Locations

Country Name City State
United Kingdom Diabetes & Vascular Medicine Research Centre, Clinical Research Facility Exeter Devon

Sponsors (1)

Lead Sponsor Collaborator
University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quantity of nitrate -reducing bacteria Change in total quantity of nitrate-reducing bacteria as measured by sequencing bacterial 16S rRNA genes 14 days
Secondary Nitric oxide bioavailability - plasma nitrite Change in nitrite concentration of plasma as measured by ozone-based chemiluminescence 14 days
Secondary Nitric oxide bioavailability - salivary nitrite Change in nitrite concentration of saliva as measured by ozone-based chemiluminescence 14 days
Secondary Nitric oxide bioavailability - plasma nitrate Change in nitrate concentration of plasma as measured by ozone-based chemiluminescence 14 days
Secondary Nitric oxide bioavailability - salivary nitrate Change in nitrate concentration of saliva as measured by ozone-based chemiluminescence 14 days
Secondary Blood pressure Change in systolic and diastolic BP 14 days
Secondary Flow mediated dilation Change in flow mediated dilation 14 days
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