Evaluating the Impact of Various Dietary Nitrate Supplements on Oral Health

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.

Conditions

• Oral Health
• Dietary Nitrate

Interventions

DIETARY_SUPPLEMENT

Control (Placebo comparator)

The control group will consume a placebo supplement, entirely free of nitrate, in the form of juice (70 ml) for four weeks while maintaining their habitual diet.

DIETARY_SUPPLEMENT

Juice (Active comparator)

The juice group will consume a beetroot supplement enriched with \~400 mg of nitrate in juice form (70 ml) for four weeks while maintaining their habitual diet.

DIETARY_SUPPLEMENT

Crystals (Experimental)

The crystals group will consume a beetroot supplement enriched with \~400 mg of nitrate in crystals form (20g) for four weeks while maintaining their habitual diet.

Sponsors & Collaborators

• Northumbria University

  collaborator OTHER

• Edith Cowan University

  collaborator OTHER

• University of the West of Scotland

  collaborator OTHER

• Shatha Alhulaefi

  lead OTHER

Principal Investigators

• Oliver Shannon, PhD · Newcastle University

• Anthony Watson, PhD · Newcastle University

• Sheena Ramsay, PhD · Newcastle University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-05-23

Primary Completion

2025-12-31

Completion

2026-04-30

Countries

• United Kingdom

Study Locations