NCT06956612 Evaluating the Impact of Various Dietary Nitrate Supplements on Oral Health
| NCT ID | NCT06956612 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shatha Alhulaefi |
| Condition | Oral Health |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-05-23 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-05-23 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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
Inclusion Criteria: * Healthy volunteers * Aged 18 - 65 years. Exclusion Criteria: * 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. * 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.
Contact & Investigator
Oliver Shannon, PhD
PRINCIPAL INVESTIGATOR
Newcastle University
Frequently Asked Questions
Who can join the NCT06956612 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Oral Health. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06956612 currently recruiting?
Yes, NCT06956612 is actively recruiting participants. Contact the research team at S.Alhulaefi2@newcastle.ac.uk for enrollment information.
Where is the NCT06956612 trial being conducted?
This trial is being conducted at Newcastle, United Kingdom.
Who is sponsoring the NCT06956612 clinical trial?
NCT06956612 is sponsored by Shatha Alhulaefi. The principal investigator is Oliver Shannon, PhD at Newcastle University. The trial plans to enroll 60 participants.