Dietary Nitrate Gum for Gum Disease and Heart Health

Overseen By Harlan Shiau

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must not be taking: Antibiotics, NSAIDs, Anticoagulants, Oral rinses

Disqualifiers: Significant bone loss, Smoking, Pregnancy, others

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if chewing gum with dietary nitrate can improve gum and heart health. Dietary nitrates, found in vegetables like beets, are being tested for their effects on gum irritation and heart function. Participants will chew either gum with dietary nitrate or a placebo for three weeks. This study targets individuals with mild to moderate gum irritation or bleeding who have at least 20 natural teeth and can chew gum. As an unphased trial, it offers a unique opportunity to explore potential health benefits from a natural source.

Will I have to stop taking my current medications?

The trial requires that you stop using antibiotics, anti-inflammatory drugs, and anticoagulants at least 14 days before participating. You also cannot use any oral rinses during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dietary nitrate, found in foods like beets and leafy greens, is generally safe. Studies have found that consuming nitrate, such as through beetroot juice, is well-tolerated. Specifically, short-term use has not been linked to serious side effects.

For heart health, dietary nitrate has been shown to lower blood pressure and improve blood flow, suggesting it works without causing harm. While researchers continue to study its effects on gum disease, no major negative effects have been reported. This suggests the treatment is likely safe for most people, especially in the short term.

Overall, current evidence supports the safety of dietary nitrate in humans, but ongoing studies will provide more detailed information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for gum disease and heart health, which often involve antibiotics or lifestyle changes, the dietary nitrate gum introduces a novel approach by delivering dietary nitrates directly through chewing. This unique delivery method allows for direct absorption in the mouth, potentially enhancing oral and cardiovascular health simultaneously. Researchers are excited because dietary nitrates may improve blood flow and reduce inflammation, offering a dual benefit not commonly achieved with current treatments.

What evidence suggests that dietary nitrate gum is effective for gum disease and heart health?

Research shows that beetroot juice, rich in dietary nitrate, can improve heart health by lowering blood pressure and boosting blood flow. Studies have also found that dietary nitrate benefits oral health by reducing gum inflammation and irritation. This trial will test a gum containing dietary nitrate, which converts into nitric oxide in the body, relaxing blood vessels and improving circulation. This could enhance gum health and provide heart benefits. Participants in this trial may receive either the dietary nitrate gum or a placebo gum without dietary nitrate. ^{1 2 4 5 6}

Who Is on the Research Team?

Harlan Shiau

Principal Investigator

Clinical Assoc. Prof.

Are You a Good Fit for This Trial?

This trial is for adults with mild to moderate gum disease, evidenced by a specific gingivitis score and having at least 20 natural teeth. Participants must be able to chew gum. It's not specified who can't join because the exclusion criteria are missing.

Inclusion Criteria

I have mild to moderate gum disease.

Subjects must be able to chew gum

I have at least 20 natural teeth.

Exclusion Criteria

Significant alveolar bone loss (>3.0 mm CEJ to bone)

Pregnancy

I need antibiotics before dental work.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized to use either a dietary nitrate gum or a placebo gum for three weeks

3 weeks

1 visit (in-person) at the start, 1 visit (in-person) at the end

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Nitrate
• Placebo Chewing Gum

Trial Overview The study tests if chewing gum with dietary nitrate improves oral and heart health compared to placebo gum. Participants will be randomly assigned to one of these two groups for three weeks, undergo dental exams, saliva and blood sampling, breath analysis for nitric oxide levels, and heart health assessments.

How Is the Trial Designed?

Group I: Test arm of dietary nitrate containing gum Experimental Treatment 1 Intervention

Functional gum with dietary nitrate

Group II: Placebo arm of non-dietary nitrate gum Placebo Group 1 Intervention

Placebo gum with no dietary nitrate

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

In a study involving 10 healthy males, different forms of inorganic nitrate (NO3-) supplementation were tested, showing that concentrated beetroot juice (BR) was the most effective at reducing blood pressure, specifically lowering systolic and mean arterial pressure.

All forms of NO3- increased nitric oxide metabolites in the body, but the concentrated beetroot juice led to the highest levels of plasma NO2- and was the only form to significantly reduce blood pressure, highlighting its potential for improving cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of dietary nitrate food forms on nitrate metabolism and blood pressure in healthy normotensive adults. McDonagh, STJ., Wylie, LJ., Webster, JMA., et al.[2019]

In a 12-week study with adults, those consuming beetroot juice containing 380 mg of nitrate showed a significant increase in plasma nitrite levels (273.2% change) compared to a placebo group (4.9% change).

Long-term consumption of beetroot juice effectively enhances the body's ability to convert dietary nitrate into plasma nitrate and nitrite, indicating its potential benefits for cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Variability in Plasma Nitrite Levels during Long-Term Supplementation with Nitrate Containing Beetroot Juice. Miller, GD., Collins, S., Ives, J., et al.[2023]

In a study involving 12 healthy older adults, dietary nitrate supplementation from concentrated beetroot juice significantly reduced resting blood pressure, with systolic pressure decreasing from 120 mmHg to 115 mmHg and diastolic pressure from 73 mmHg to 70 mmHg.

Nitrate supplementation improved the speed of oxygen uptake response during exercise, reducing the time taken to transition from rest to walking, but did not enhance overall walking performance or cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of short-term dietary nitrate supplementation on blood pressure, O2 uptake kinetics, and muscle and cognitive function in older adults. Kelly, J., Fulford, J., Vanhatalo, A., et al.[2022]

Ingesting beetroot juice rich in nitrate (NO3-) significantly increases plasma levels of both nitrate and nitrite (NO2-), which can positively affect cardiovascular measures like mean arterial pressure (MAP).

While both NO3- and NO2- have the potential to lower MAP, the expected reduction in systolic and diastolic blood pressure was not observed, suggesting that the role of NO2- in blood pressure regulation alongside NO3- needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Nitrate and Nitrite Following Beetroot Juice Drink Consumption. Jakubcik, EM., Rutherfurd-Markwick, K., Chabert, M., et al.[2021]

Citations

1. nature.com nature.com/articles/s41522-024-00622-5

The blood pressure lowering effect of beetroot juice is ... This is the first study showing that periodontitis could limit the blood-pressure lowering effects of nitrate reduction by the oral microbiota.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06956612

Evaluating the Impact of Various Dietary Nitrate ... This study aims to investigate the effects of different dietary nitrate supplements, versus placebo, on microbiological and immunological markers associated ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/10408398.2024.2351168

Effects of dietary nitrate supplementation on oral health ... This systematic review investigated the effects of dietary nitrate on markers of oral health in vivo in randomized controlled trials (RCTs).

4. withpower.com withpower.com/trial/phase-gingivitis-9-2023-5e17f

Dietary Nitrate Gum for Gum Disease and Heart Health Research shows that beetroot juice, which is rich in dietary nitrate, can improve heart health by lowering blood pressure and increasing blood flow. This is ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01682356

NCT01682356 | Dietary Nitrate for Heart Failure The purpose of this study is to determine if nitrates in a food, in this case - beetroot juice (BRJ) - is efficacious in improving exercise tolerance and/or ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11257697/

Effects of short-term dietary nitrate supplementation on ... Overall, these preliminary findings suggest that inorganic nitrate supplementation in PAD patients is safe, well-tolerated, and may improve the ...