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Sponsor study identifier
interventional
60
1 country
1
Study Start
May 23, 2025
Actual (reported)Primary Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study aims to investigate the effects of different dietary nitrate supplements, versus placebo, on microbiological and immunological markers associated with oral health in people aged 18-65 years. The main research questions are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 24, 2025
Actual (reported)May 4, 2025
Actual (reported)May 23, 2025
Actual (reported)December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Saliva pH
Prior to and following the intervention, participants will provide an unstimulated saliva sample for pH measurement. The pH of each saliva sample will be measured using a pre-calibrated pH meter (±0.01 pH accuracy). Measurements will be performed in three independent replicates for each sample, with the three values recorded and then averaged. This average is used for the final pH value of the sample, helping to reduce the influence of random errors and improve the accuracy and reliability of the results. The device is recalibrated prior to measurements using standard calibration solutions to ensure accurate readings.
4 weeks
Oral microbiome
Prior to and following the intervention, participants will provide unstimulated saliva and tongue swab samples. DNA will be extracted from both the saliva and tongue swab samples, and 16S rRNA sequencing will be performed to identify and quantify changes in the oral microbiome.
4 weeks
Salivary nitrate/ nitrite concentrations
4 weeks
Saliva flow rate
4 weeks
Salivary biomarkers
4 weeks
Dry mouth severity (Xerostomia)
4 weeks
Oral hygiene behaviours
4 weeks
Daily supplementation with 70 ml nitrate-depleted Beet It Sport Shots, James White Ltd (\~0mg dietary nitrate)
Daily supplementation with 70 ml Beet It Sport Shots, James White Ltd (\~400mg nitrate).
Daily supplementation with 20g Beet It Sport Crystals, James White Ltd (\~400mg nitrate).
The control group will consume a placebo supplement, entirely free of nitrate, in the form of juice (70 ml) for four weeks while maintaining their habitual diet.
The juice group will consume a beetroot supplement enriched with \~400 mg of nitrate in juice form (70 ml) for four weeks while maintaining their habitual diet.
Newcastle University, Newcastle upon Tyne, Tyne and Wear NE2 4HH
Newcastle, NE2 4HH, United Kingdom
Oliver Shannon, PhD
Newcastle University
Anthony Watson, PhD
Newcastle University
Sheena Ramsay, PhD
Newcastle University
First Submitted
April 24, 2025
First Posted
May 4, 2025
Study Start
May 23, 2025
Actual (reported)The crystals group will consume a beetroot supplement enriched with \~400 mg of nitrate in crystals form (20g) for four weeks while maintaining their habitual diet.
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Primary Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 28, 2025
Record last verified: 2025-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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