Probiotic Effect on Dietary Nitrate to Plasma Nitrite Production ( OPEDNPN )
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorWake Forest University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adult volunteers ages 18-70
Disqualifiers
Individuals with a history of difficult blood draws. More than 2 blood draws in one week; on anti-coagulant or anti-platelet therapy (e.g. aspirin, Coumadin, etc.); known pregnancy; in police custody or a prisoner; common illness within 2 weeks of potential enrollment. The cumulative volume of blood drawn from a healthy adult over the prior eight-week period would exceed 550 ml including the current draw.
In addition, individuals uncomfortable spitting into a tube, dry mouth (xerostomia) or dry eyes, Patients suffering from autoimmune diseases such as Sjogren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, or progressive systemic sclerosis, since individuals with these autoimmune inflammatory diseases exhibit persistent xerostomia, individuals with active caries diagnosis or history of periodontitis
Trial design
Design model
Parallel
Treatments tested in this trial
Herbiotics Oral + Ent Probiotic
Dietary supplementChewable Tablets containing Lactobacillus species.
Placebo
Dietary supplementHonest Placebo Pills by Zeebo
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: ProbioticActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Dietary Nitrate Conversion to Plasma Nitrite
The main outcome is the plasma nitrite level 2.5 after consuming Beet Juice minus the plasma nitrite level prior to drinking beet juice. Blood will be collected prior to drinking one Beet it Sport shot and 2.5 hours after drinking the shot. Plasma nitrite will be measured from these blood draws. This outcome will be measured at two visits: baseline and followup (day 8) and the increase in plasma nitrite at the two visits will be compared. Between the two visits the participants will consume the Probiotic or Placebo for 7 days.
Time frame
The two visits will be 8 days apart.Secondary outcomes
1
Percentage Lactobacillus
Oral bacterial species will be determined from saliva and tongue scrapings at both visits prior to beet juice consumption. The percentage abundance of Lactobacillus will be determined at each visit and compared to each other. Between the two visits the participants will consume the Probiotic or Placebo for 7 days.
Time frame
The two visits will be 8 days apart.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Wake Forest University
Lead sponsor
University of South Florida
Collaborator
Source ClinicalTrials.gov