Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06956612

Evaluating the Impact of Various Dietary Nitrate Supplements on Oral Health

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

60

Participants Needed

1

Research Sites

44 weeks

Total Duration

On this page

Sponsors

S

Shatha Alhulaefi

Lead Sponsor

N

Northumbria University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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 - 65 years.
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

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

Newcastle, United Kingdom, NE2 4HH

Actively Recruiting

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Research Team

S

Shatha Alhulaefi

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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