The Effect of Dietary Nitrate on the Oral Microbiome

Cardiovascular Health Clinical Trial

— Microbio  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03467061
• Other study ID #: 1718/14
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cardiovascular Health
• Identify Oral Bacteria Responsible for Nitrate Reduction

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