Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Healthy adult volunteers ages 18-70
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
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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