Healthy Individuals With no Periodontal DiseaseNCT07865481
The Effect of Nitrate Supplementation on Tongue Microbiome
A study testing Nitrate-Supplemented Beet Juice and Nitrate-Depleted Beet Juice in people with Healthy Individuals With no Periodontal Disease, run by The Forsyth Institute at 1 site in United States.
Trial summary
The objective of this study is to investigate how the host environment influences microbiome structure. Specifically, the spatial organization of nitrate-metabolizing bacteria that will flourish in high and low salivary nitrate concentrations will be studied. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals With no Periodontal Disease
- What is being tested?
- Nitrate-Supplemented Beet Juice and Nitrate-Depleted Beet Juice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2025to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to read, understand, and sign the Informed Consent form.
- Between the ages of 18 and 65 years
- Willing and able to follow the study instructions, restrictions, and dietary supplementation.
Who cannot join
- Antibiotic use in the previous 6 months
- Individuals requiring prophylactic antibiotics
- Acute infectious diseases such as tuberculosis or hepatitis
- Oral diseases, including gingivitis, periodontitis, oral cancer, or untreated severe dental caries.
- Fixed orthodontic appliances or removable dentures
- Soft or hard tissue tumor in the oral cavity
Show all 16Show fewer
- Heavy supra and subgingival calculus
- Diagnosed with any systemic inflammatory or infectious disease (e.g., diabetes, hypertension, cardiovascular diseases, endocrine diseases, inflammatory bowel diseases, rheumatoid arthritis, or other related diseases)
- Regular use of prescription medications (any medications for the conditions listed above or non-steroidal anti-inflammatory medications, or steroids)
- Current tobacco use, including smoking, chewing, and vaping or marijuana use (within 12 months)
- History of alcohol or drug abuse
- Dietary supplements, including sports drinks containing high levels of nitrate
- Consuming nitrate-rich foods such as beets and leafy greens >3 times/week
- Allergy to ingredients of beetroot juice used in this study.
- Individuals <110 pounds of body weight.
- Pregnancy or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
ADA Forsyth Institute
Somerville, Massachusetts, 02134
About this study
Official title: The Effect of Nitrate Supplementation on Tongue Microbiome Structure - a Double-blind Crossover Study
The objective of this study is to investigate how the host environment influences microbiome structure. Specifically, the spatial organization of nitrate-metabolizing bacteria that will flourish in high and low salivary nitrate concentrations will be studied.
Read the detailed description
This is a 12-week, randomized, double-blind, crossover design study in which healthy subjects (18-65 years old) will be randomly assigned to a treatment sequence (AB/BA). The subjects will be asked to attend the clinic for nine visits following the screening/baseline visit. Each participant will be screened for admission and undergo nine study visits in two test periods, separated by a 4-week washout period. Clinical periodontal and dental recordings will be obtained at the screening to determine eligibility. At each visit, blood pressure measurements will be taken using a dedicated and calibrated blood pressure monitor. There will be three weekly samples (D0, D7, and D14) to measure normal within-subject variation before the first dietary supplementation period between D14 and D28. During dietary supplementation, weekly samples (saliva, supragingival dental plaque, and tongue scraping) will be collected (D21 and D28), whereafter, the subjects will enter a 4-week washout period with one-time sampling in the middle (D42) before the second supplementation period starts. The second supplementation period will also include weekly sampling (D56, D63, and D70), followed by a 2-week washout period, after which a final visit for sampling will be conducted.
- Being tested
- Nitrate-Supplemented Beet Juice, Nitrate-Depleted Beet Juice
- Keywords
- Nitrate Supplementation, Microbiome, Beet Juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrate-Supplemented Beet JuiceDietary supplement
Nitrate-supplemented beet juice (70 ml) will be consumed twice a day for 14 days.
Nitrate-Depleted Beet JuiceDietary supplement
Beet juice (70 ml) not containing nitrate will be consumed twice a day for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Nitrate-Supplemented Beet Juice | Experimental | A commercially available sport drink (BeetIT) will be administered to assess changes in oral bacterial composition. Receives: Dietary Supplement: Nitrate-Supplemented Beet Juice |
| Nitrate-Depleted Beet Juice | Placebo comparator | A commercially available sport drink (BeetIT) without nitrate supplementation will be administered to compare changes in oral bacterial composition. Receives: Dietary Supplement: Nitrate-Depleted Beet Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome profiles on the tongue dorsum and supragingival plaque
16S rRNA gene profiling on the tongue dorsum and supragingival plaque will be performed to determine the changes in taxa following notrate supplementation.
Measured: 14 days
Secondary outcomes (2)
Functional activities of bacterial taxa on the tongue and supragingival biofilm samples
Functional profiles of bacterial taxa will be assessed via metagenomic sequencing
Measured: 14 days
Spatial Organization of the tongue and supragingival microbiome
Spatial organization of the oral microbiome will be assessed by CLASI-FISH
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start13 Sep 2025
- Primary completion17 Dec 2025
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Individuals With no Periodontal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Forsyth Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Hatice Hasturk, The Forsyth Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865481
- Sponsor's protocol ID
- NIH2825
- Other IDs
- R01DE022586
- Status last verified
- Oct 2026
- First submitted
- 27 Jun 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Microbiome data
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nitrate Supplementation on Tongue Microbiome Structure - a Double-blind Crossover Study
- ClinicalTrials.gov ID
- NCT07865481
- Acronym / sponsor ID
- NIH2825
- Keywords
- Nitrate Supplementation, Microbiome, Beet Juice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The Forsyth InstituteUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 13 Sep 2025 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to investigate how the host environment influences microbiome structure. Specifically, the spatial organization of nitrate-metabolizing bacteria that will flourish in high and low salivary nitrate concentrations will be studied.
Detailed description
This is a 12-week, randomized, double-blind, crossover design study in which healthy subjects (18-65 years old) will be randomly assigned to a treatment sequence (AB/BA). The subjects will be asked to attend the clinic for nine visits following the screening/baseline visit. Each participant will be screened for admission and undergo nine study visits in two test periods, separated by a 4-week washout period. Clinical periodontal and dental recordings will be obtained at the screening to determine eligibility. At each visit, blood pressure measurements will be taken using a dedicated and calibrated blood pressure monitor. There will be three weekly samples (D0, D7, and D14) to measure normal within-subject variation before the first dietary supplementation period between D14 and D28. During dietary supplementation, weekly samples (saliva, supragingival dental plaque, and tongue scraping) will be collected (D21 and D28), whereafter, the subjects will enter a 4-week washout period with one-time sampling in the middle (D42) before the second supplementation period starts. The second supplementation period will also include weekly sampling (D56, D63, and D70), followed by a 2-week washout period, after which a final visit for sampling will be conducted.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrate-Supplemented Beet Juice | Experimental | Dietary Supplement: Nitrate-Supplemented Beet JuiceA commercially available sport drink (BeetIT) will be administered to assess changes in oral bacterial composition. |
| Nitrate-Depleted Beet Juice | Placebo comparator | Dietary Supplement: Nitrate-Depleted Beet JuiceA commercially available sport drink (BeetIT) without nitrate supplementation will be administered to compare changes in oral bacterial composition. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing and able to read, understand, and sign the Informed Consent form.
- Between the ages of 18 and 65 years
- Willing and able to follow the study instructions, restrictions, and dietary supplementation.
Key exclusion criteria (16 listed)
- Antibiotic use in the previous 6 months
- Individuals requiring prophylactic antibiotics
- Acute infectious diseases such as tuberculosis or hepatitis
- Oral diseases, including gingivitis, periodontitis, oral cancer, or untreated severe dental caries.
- Fixed orthodontic appliances or removable dentures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrate-Supplemented Beet JuiceNitrate-supplemented beet juice (70 ml) will be consumed twice a day for 14 days. | Dietary supplement | Nitrate-Supplemented Beet Juice |
| Nitrate-Depleted Beet JuiceBeet juice (70 ml) not containing nitrate will be consumed twice a day for 14 days. | Dietary supplement | Nitrate-Depleted Beet Juice |
Primary outcome
Microbiome profiles on the tongue dorsum and supragingival plaque
Time frame: 14 days
16S rRNA gene profiling on the tongue dorsum and supragingival plaque will be performed to determine the changes in taxa following notrate supplementation.
2 secondary outcomes
Functional activities of bacterial taxa on the tongue and supragingival biofilm samples
Time frame: 14 days
Spatial Organization of the tongue and supragingival microbiome
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes. Microbiome data
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrate-Supplemented Beet Juice and Nitrate-Depleted Beet Juice in people with Healthy Individuals With no Periodontal Disease, run by The Forsyth Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome profiles on the tongue dorsum and supragingival plaque (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.