Clinical trial NCT06956612: Evaluating the Impact of Various Dietary Nitrate Supplements on Oral Health
Official title: Evaluating the Impact of Various Dietary Nitrate Supplementation Forms on Microbiological Markers of Oral Health and Acceptability Among Adult Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Health
Dietary Nitrate
Keywords: Dietary nitrate
oral health
salivary acidity
oral microbiome
Lead sponsor: Newcastle University
Sponsor class: OTHER
Collaborators: name: Northumbria University
name: Edith Cowan University
name: University of the West of Scotland
First posted: 2025-05-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Primary outcomes:
measure: Saliva pH
timeFrame: 4 weeks
measure: Oral microbiome
timeFrame: 4 weeks
Secondary outcomes:
measure: Salivary nitrate/ nitrite concentrations
timeFrame: 4 weeks
measure: Saliva flow rate
timeFrame: 4 weeks
measure: Salivary biomarkers
timeFrame: 4 weeks
measure: Dry mouth severity (Xerostomia)
timeFrame: 4 weeks
measure: Oral hygiene behaviours
timeFrame: 4 weeks
measure: Dietary nitrate intake assessment
timeFrame: 4 weeks
measure: Intervention acceptability
timeFrame: 4 weeks
measure: Participant Compliance
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Newcastle
country: United Kingdom
facility: Newcastle University, Newcastle upon Tyne, Tyne and Wear NE2 4HH
Study officials:
affiliation: Newcastle University
name: Oliver Shannon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Newcastle University
name: Anthony Watson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Newcastle University
name: Sheena Ramsay, PhD
role: PRINCIPAL_INVESTIGATOR
References: