Evaluating the Impact of Various Dietary Nitrate Supplements on Oral Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShatha Alhulaefi
About this trial
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:
* How do different dietary nitrate supplements (beetroot crystals vs. beetroot juice) affect oral health markers, including salivary pH and oral microbiome composition? * What is the acceptability and ease of integrating one of dietary nitrate supplements, made from beetroot but processed as freeze dried crystals or juice, into the daily diet?
To answer these questions, the study will compare results from three groups of participants, who will be randomly assigned to one of the following study arms:
Group 1: The control group will consume a placebo beetroot supplement completely free of nitrate in juice form.
Group 2: The beetroot juice group will consume a beetroot supplement standardised to contain \~ 400 mg of nitrate in juice form.
Group 3: The beetroot crystals group will consume a beetroot supplement standardised to contain \~400 mg of nitrate in freeze dried crystal form.
The study will follow a randomised, single-blind, placebo-controlled, parallel design, and the intervention will last for four weeks. Data will be collected by providing pre- and post-intervention saliva samples tongue swabs, and various questionnaires will be completed at baseline and at the end of the study. In addition, at the end of the second week of the intervention period, participants will be asked to collect a saliva sample over three consecutive days at home.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy volunteers
Aged 18 - 65 years.
Disqualifiers
Aged less than 18 or more than 65 years old.
Current smoking
Alcohol consumption of greater than14 units per week.
Diagnosis of a chronic disease (e.g., cardiovascular disease, diabetes, cancer, or gastrointestinal disorders), including oral diseases.
Trial design
Design model
Parallel
Treatments tested in this trial
Control (Placebo comparator)
Dietary supplementThe 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.
Juice (Active comparator)
Dietary supplementThe 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.
Crystals (Experimental)
Dietary supplementThe 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: ControlPlacebo comparator 1 intervention
Group B: JuiceActive comparator 1 intervention
Group C: CrystalsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
4 weeks2
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.
Time frame
4 weeksSecondary outcomes
1
Salivary nitrate/ nitrite concentrations
Prior to and following the intervention, participants will provide an unstimulated saliva sample to determine saliva nitrate and nitrite levels using ozone-based chemiluminescence. Home-collected saliva samples will also be analysed for three consecutive days to ensure compliance.
Time frame
4 weeks2
Saliva flow rate
Participants will provide an unstimulated saliva sample prior to and following the intervention. The saliva volume collected (in mL) will be divided by the time taken (in min) to obtain the flow rate in ml/min.
Time frame
4 weeks3
Salivary biomarkers
Participants will provide an unstimulated saliva sample prior to and following the intervention. If sufficient sample volume is available, exploratory analysis of salivary biomarkers related to inflammation may be considered.
Time frame
4 weeks4
Dry mouth severity (Xerostomia)
The impact of the study interventions on dry mouth symptom severity pre- and post-intervention will be assessed using the Summated Xerostomia Inventory-Dutch Version (SXI-D) questionnaire (Thomson et al., 2011), which has been validated in clinical and epidemiological research. Participants will provide information about their oral symptoms over the previous four weeks (e.g., feeling dry mouth or difficulty eating dry foods). Participants will be asked to select one of three options, each of which is associated with a score (Never (1); Occasionally (2) and Often, (3)). The SXI-D score range is 5-15, with higher scores indicating more severe dry mouth.
Time frame
4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shatha Alhulaefi
Lead sponsor
Newcastle University
Sponsor institution
Northumbria University
Collaborator
Edith Cowan University
Collaborator
University of the West of Scotland
Collaborator
Source ClinicalTrials.gov