Oral Probiotic Effect on Dietary Nitrate to Plasma Nitrite Production

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• Healthy adult volunteers ages 18-70

Locations
United States
North Carolina
Wake Forest University
RECRUITING
Winston-salem
Contact Information
Primary
Daniel B Kim-Shapiro, PhD
shapiro@wfu.edu
336-758-4993
Backup
Jeanie Baird, MPA
bairdjl@wfu.edu
336-758-5195
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2025-05
Participants
Target number of participants: 20
Treatments
Active_comparator: Probiotic
Participants will take the commercially available oral probiotic (Herbiotics Oral + Ent Probiotic) twice a day for 7 days as instructed by the manufacturer. This entails one lozenge twice a day taken by mouth and slowly chewed or allowed to melt in the mouth.
Placebo_comparator: Placebo
Participants will take the commercially available Honest Placebo Pills by Zeebo twice a day for 7 days. This entails one tablet twice a day taken by mouth and slowly chewed or allowed to melt in the mouth.
Related Therapeutic Areas
Sponsors
Collaborators: University of South Florida
Leads: Wake Forest University

This content was sourced from clinicaltrials.gov