Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06956612

Evaluating the Impact of Various Dietary Nitrate Supplementation Forms on Microbiological Markers of Oral Health and Acceptability Among Adult Participants

Led by Shatha Alhulaefi · Updated on 2025-05-28

60

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

S

Shatha Alhulaefi

Lead Sponsor

N

Northumbria University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how different dietary nitrate supplements affect markers related to oral health in adults aged 18 to 65 years. This study compares beetroot supplements in two forms—freeze-dried crystals and juice—against a placebo to understand their impact on saliva pH, oral microbiome, and other microbiological and immunological indicators. The study also explores how easy and acceptable it is to include these nitrate supplements in daily diets. Participants will be randomly assigned to one of three groups: a control group receiving a nitrate-free placebo juice, a group receiving beetroot juice containing about 400 mg of nitrate daily, and a group receiving beetroot crystals with a similar nitrate content. The intervention lasts four weeks, during which participants maintain their usual diets while taking the assigned supplement daily. Throughout the study, saliva samples and tongue swabs are collected before and after the intervention period, with additional saliva samples taken at home over three consecutive days during the second week. Participants complete questionnaires at the start and end of the study to assess oral health markers, dietary nitrate intake, acceptability of the supplements, and compliance. The main outcomes measured include saliva pH and oral microbiome changes after four weeks, along with other salivary and oral health indicators.

CONDITIONS

Brief Title

Evaluating the Impact of Various Dietary Nitrate Supplements on Oral Health

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy volunteers
  • Aged 18 to 65 years
Not Eligible

You will not qualify if you...

  • Younger than 18 or older than 65 years
  • Current smoking
  • Alcohol consumption greater than 14 units per week
  • Diagnosis of chronic diseases including cardiovascular disease, diabetes, cancer, gastrointestinal or oral diseases
  • Use of antibiotics within the past three months or medications/supplements affecting the oral cavity
  • Regular use of antibacterial mouthwash, xylitol products, or proton pump inhibitors
  • Presence of braces, Invisalign, or dentures
  • Known allergy to any food including beets
  • Following dietary restrictions such as weight loss diets
  • Eating disorders that limit study participation
  • Currently pregnant, breastfeeding, or trying to become pregnant
  • Participation in other studies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 weeks

Participants consume daily dietary nitrate supplements or placebo for four weeks while maintaining their habitual diet. They are monitored for changes in oral health markers and supplement acceptability.

Weekly visits for up to 4 weeks

Trial Site Locations

Total: 1 location

1

Newcastle University, Newcastle upon Tyne, Tyne and Wear NE2 4HH

Newcastle, United Kingdom, NE2 4HH

Actively Recruiting

Loading map...

Research Team

S

Shatha Alhulaefi

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

Similar Trials

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here