NCT06956612

Evaluating the Impact of Various Dietary Nitrate Supplements on Oral Health

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shatha Alhulaefi · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-05-23
• Primary completion: 2025-12-01
• Completion: 2026-04-01
• First posted: 2025-05-04
• Last updated: 2025-05-28

Locations

1 site across 1 country: United Kingdom