Oral HealthNCT06956612
Evaluating the Impact of Various Dietary Nitrate Supplements on Oral Health
A study testing Juice (Active comparator) and Crystals (Experimental) in people with Oral Health and Dietary Nitrate, run by Shatha Alhulaefi at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health, Dietary Nitrate
- What is being tested?
- Juice (Active comparator) and Crystals (Experimental)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 May 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Aged 18 - 65 years.
Who cannot join
- 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.
- Use of antibiotics within the past three months or medications/nutritional supplements that may affect the oral cavity (e.g., prebiotics, probiotics, or hormone replacement therapy).
- Regular use of antibacterial mouthwash or xylitol-containing products (e.g., gum or toothpaste) or the use of proton pump inhibitors.
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- Presence of braces/invisalign or dentures.
- Known allergy to any food, including beets
- Adherence to dietary restrictions (e.g., weight loss diet)
- Eating disorders that may limit participation in the study.
- Currently pregnant, breastfeeding or trying to become pregnant.
- Participation in other studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Newcastle University, Newcastle upon Tyne, Tyne and Wear NE2 4HH
Newcastle, NE2 4HH
Shatha Alhulaefi, +44783361076, S.Alhulaefi2@newcastle.ac.uk
About this study
Official title: Evaluating the Impact of Various Dietary Nitrate Supplementation Forms on Microbiological Markers of Oral Health and Acceptability Among Adult Participants
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:
Read more
- 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.
- Conditions
- Oral Health, Dietary Nitrate
- Being tested
- Control (Placebo comparator), Juice (Active comparator), Crystals (Experimental)
- Keywords
- Dietary nitrate, oral health, salivary acidity, oral microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control (Placebo comparator)Dietary supplement
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.
Juice (Active comparator)Dietary supplement
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.
Crystals (Experimental)Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Daily supplementation with 70 ml nitrate-depleted Beet It Sport Shots, James White Ltd (~0mg dietary nitrate) Receives: Dietary Supplement: Control (Placebo comparator) |
| Juice | Active comparator | Daily supplementation with 70 ml Beet It Sport Shots, James White Ltd (~400mg nitrate). Receives: Dietary Supplement: Juice (Active comparator) |
| Crystals | Experimental | Daily supplementation with 20g Beet It Sport Crystals, James White Ltd (~400mg nitrate). Receives: Dietary Supplement: Crystals (Experimental) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (8)
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Oral hygiene behaviours
Participants will provide information on their oral hygiene behaviours before and after the intervention using the Oral Hygiene Behaviour Index questionnaire (Buunk-Werkhoven et al., 2011). The score ranges from 0 to 16, with a high total score indicating a high level of oral hygiene practices.
Measured: 4 weeks
Dietary nitrate intake assessment
Before and after the intervention, participants will provide information about their intake of nitrate containing foods through a validated digital food frequency questionnaire(McMahon et al., 2023).
Measured: 4 weeks
Intervention acceptability
The acceptability of the interventions will be assessed after the study is completed through a questionnaire designed to measure acceptability dimensions according to the Theoretical Framework of Acceptability (Sekhon et al., 2017), using a 5-point Likert scale to assess different aspects such as overall acceptability, palatability, and ease of use.
Measured: 4 weeks
Participant Compliance
Compliance will be assessed using a participant-completed compliance log over a 4-week period. Participants will be asked to record:
- The date and time of supplement intake.
- How it was consumed. Additionally, any unused supplement sachets/bottles will be collected at the final visit to help estimate adherence.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start23 May 2025
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shatha Alhulaefi
- Sponsor type
- University, hospital or other
- Collaborators
- Northumbria University, Edith Cowan University, University of the West of Scotland
- Responsible party
- Sponsor-investigator, Shatha Alhulaefi, Newcastle University
- Investigators
- Oliver Shannon, PhD, Principal investigator, Newcastle UniversityAnthony Watson, PhD, Principal investigator, Newcastle UniversitySheena Ramsay, PhD, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956612
- Sponsor's protocol ID
- 2966/53998
- Status last verified
- May 2025
- First submitted
- 24 Apr 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Various Dietary Nitrate Supplementation Forms on Microbiological Markers of Oral Health and Acceptability Among Adult Participants
- ClinicalTrials.gov ID
- NCT06956612
- Acronym / sponsor ID
- 2966/53998
- Conditions
- Oral Health, Dietary Nitrate
- Keywords
- Dietary nitrate, oral health, salivary acidity, oral microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shatha AlhulaefiUniversity, hospital or other
- Collaborators
- Northumbria University, Edith Cowan University, University of the West of Scotland
- Study start
- 23 May 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Control (Placebo comparator)Daily supplementation with 70 ml nitrate-depleted Beet It Sport Shots, James White Ltd (~0mg dietary nitrate) |
| Juice | Active comparator | Dietary Supplement: Juice (Active comparator)Daily supplementation with 70 ml Beet It Sport Shots, James White Ltd (~400mg nitrate). |
| Crystals | Experimental | Dietary Supplement: Crystals (Experimental)Daily supplementation with 20g Beet It Sport Crystals, James White Ltd (~400mg nitrate). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers
- Aged 18 - 65 years.
Key exclusion criteria (12 listed)
- 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.
- Use of antibiotics within the past three months or medications/nutritional supplements that may affect the oral cavity (e.g., prebiotics, probiotics, or hormone replacement therapy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control (Placebo comparator)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. | Dietary supplement | Control |
| Juice (Active comparator)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. | Dietary supplement | Juice |
| Crystals (Experimental)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. | Dietary supplement | Crystals |
Primary outcome
Saliva pH
Time frame: 4 weeks
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.
Oral microbiome
Time frame: 4 weeks
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.
8 secondary outcomes
Salivary nitrate/ nitrite concentrations
Time frame: 4 weeks
Saliva flow rate
Time frame: 4 weeks
Salivary biomarkers
Time frame: 4 weeks
Dry mouth severity (Xerostomia)
Time frame: 4 weeks
Oral hygiene behaviours
Time frame: 4 weeks
Dietary nitrate intake assessment
Time frame: 4 weeks
Intervention acceptability
Time frame: 4 weeks
Participant Compliance
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oliver Shannon, PhD principal investigator
Newcastle University
Anthony Watson, PhD principal investigator
Newcastle University
Sheena Ramsay, PhD principal investigator
Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Juice (Active comparator) and Crystals (Experimental) in people with Oral Health and Dietary Nitrate, run by Shatha Alhulaefi at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shatha Alhulaefi (+44783361076, S.Alhulaefi2@newcastle.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saliva pH (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.