Clinical Trial

Evaluating the Impact of Various Dietary Nitrate Supplements on Oral Health

Recruiting
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Record status
This record was last updated May 28, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-24.
Status change: Not Yet Recruiting → Recruiting 2025-05-27
Trial Details
NCT Number NCT06956612
Lead Sponsor Shatha Alhulaefi
Collaborators: Northumbria University, Edith Cowan University, University of the West of Scotland
Conditions Oral Health, Dietary Nitrate
Enrollment 60 participants
Start Date 2025-05-23
Primary Completion 2025-12 (estimated)
Study Completion 2026-04 (estimated)
Updated on ClinicalTrials.gov 2025-05-28