Evaluating the Impact of Various Dietary Nitrate Supplements on Oral Health

NCT ID: NCT06956612

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-23
• Study Completion Date: 2026-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control

Daily supplementation with 70 ml nitrate-depleted Beet It Sport Shots, James White Ltd (\~0mg dietary nitrate)

Group Type: PLACEBO_COMPARATOR

Control (Placebo comparator)

Intervention Type: DIETARY_SUPPLEMENT

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.

Juice

Daily supplementation with 70 ml Beet It Sport Shots, James White Ltd (\~400mg nitrate).

Group Type: ACTIVE_COMPARATOR

Juice (Active comparator)

Intervention Type: DIETARY_SUPPLEMENT

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.

Crystals

Daily supplementation with 20g Beet It Sport Crystals, James White Ltd (\~400mg nitrate).

Group Type: EXPERIMENTAL

Crystals (Experimental)

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers
• Aged 18 - 65 years.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northumbria University

OTHER

Sponsor Role: collaborator

Edith Cowan University

OTHER

Sponsor Role: collaborator

University of the West of Scotland

OTHER

Sponsor Role: collaborator

Shatha Alhulaefi

OTHER

Sponsor Role: lead

Responsible Party

Shatha Alhulaefi

Doctoral Researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Oliver Shannon, PhD

Role: PRINCIPAL_INVESTIGATOR

Newcastle University

Anthony Watson, PhD

Role: PRINCIPAL_INVESTIGATOR

Newcastle University

Sheena Ramsay, PhD

Role: PRINCIPAL_INVESTIGATOR

Newcastle University

Locations

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

Newcastle, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Shatha Alhulaefi

Role: CONTACT

S.Alhulaefi2@newcastle.ac.uk

+44783361076

Facility Contacts

Shatha Alhulaefi

Role: primary

S.Alhulaefi2@newcastle.ac.uk

+44783361076

Other Identifiers

2966/53998

Identifier Type: -

Identifier Source: org_study_id