Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT06375694

Probiotic Effect on Dietary Nitrate to Plasma Nitrite Production ( OPEDNPN )

Led by Wake Forest University · Updated on 2024-07-19

20

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

Sponsors

W

Wake Forest University

Lead Sponsor

U

University of South Florida

Collaborating Sponsor

AI-Summary

What this Trial Is About

Nitric Oxide (NO) is an important molecule that is produced naturally in the body and that helps maintain healthy blood flow. Low availability of NO contributes to many diseases while administration of NO is therapeutic. In addition to being made naturally in the body, NO can be obtained through the diet via the Nitrate-Nitrite-NO cycle. Nitrate, which is abundant in green leafy vegetables and beetroot juice, is partially converted to nitrite by oral bacteria. The nitrate and nitrite are taken up into the blood and nitrite is converted into NO. Remaining nitrate in the blood is taken back up into the mouth by salivary glands and the cycle continues. Emerging studies suggest that the Nitrate-Nitrite-NO cycle may contribute to cardiovascular health. In addition, there have been many studies where dietary nitrate is given to increase NO and treat various conditions. The current study rests on the premise that the quality of the oral microbiome plays a major role in the Nitrate-Nitrite-NO cycle and hence cardiovascular health and the efficacy of dietary nitrate interventions. Investigators have begun to identify oral bacterial species that are effective nitrite producers as well as though that are nitrite depleters (those that interfere with nitrite production from nitrate). In laboratory experiments, certain bacterial species have been shown to block nitrate to nitrite conversion by other oral bacteria. These nitrite depleting species are found in a commercially available oral probiotic designed to improve oral health. The purpose of this study is to examine if use of the probiotic negatively affects the Nitrate-Nitrite-NO cycle. Nitrate to Nitrite conversion will be assessed by measuring plasma levels of nitrite before and after consumption of nitrate-rich beetroot juice. Dietary nitrate to plasma nitrite conversion will assessed at baseline and after one week of consumption of the probiotic or a placebo (follow-up). The primary hypothesis of this study is that participants that consume the probiotic will have lower nitrate to nitrite conversion at follow-up compared to baseline and that there will be no significant change in nitrate to nitrite conversion between baseline and follow-up for participants who consume the placebo. While this study does not aim to treat any specific disease, it is intended to elucidate a basic physiological function that may be relevant to cardiovascular health and certain NO-based therapeutics.

CONDITIONS

Official Title

Probiotic Effect on Dietary Nitrate to Plasma Nitrite Production ( OPEDNPN )

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy adult volunteers ages 18-70
Not Eligible

You will not qualify if you...

  • History of difficult blood draws or more than 2 blood draws in one week
  • Use of anti-coagulant or anti-platelet therapy (e.g. aspirin, Coumadin)
  • Known pregnancy
  • Being in police custody or a prisoner
  • Common illness within 2 weeks before enrollment
  • Cumulative blood drawn over prior eight weeks exceeding 550 ml including current draw
  • Uncomfortable spitting into a tube
  • Dry mouth (xerostomia) or dry eyes
  • Autoimmune diseases such as Sjogren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, or progressive systemic sclerosis
  • Active caries diagnosis or history of periodontitis

AI-Screening

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Trial Site Locations

Total: 1 location

1

Wake Forest University

Winston-Salem, North Carolina, United States, 27104

Actively Recruiting

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Research Team

D

Daniel B Kim-Shapiro, PhD

CONTACT

J

Jeanie Baird, MPA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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