Evaluating the Impact of Various Dietary Nitrate Supplementation Forms on Microbiological Markers of Oral Health and Acceptability Among Adult Participants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Saliva pH
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Masking Description
This study will use a single-blind design, where the participants will not know whether they receive the real supplement or the placebo. Participants will be told they might receive either crystals or juice, but they won't know whether it's an active supplement or a placebo.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Crystals
Daily supplementation with 20g Beet It Sport Crystals, James White Ltd (~400mg nitrate).
Intervention: Crystals (Experimental) (Dietary Supplement)
Juice
Daily supplementation with 70 ml Beet It Sport Shots, James White Ltd (~400mg nitrate).
Intervention: Juice (Active comparator) (Dietary Supplement)
Control
Daily supplementation with 70 ml nitrate-depleted Beet It Sport Shots, James White Ltd (~0mg dietary nitrate)
Intervention: Control (Placebo comparator) (Dietary Supplement)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- Dietary nitrate intake assessment(4 weeks)
- Intervention acceptability(4 weeks)
- Participant Compliance(4 weeks)
Investigators
Shatha Alhulaefi
Doctoral Researcher
Newcastle University