Recruiting

Probiotic Effect

Sponsor:

Wake Forest University

Code:

NCT06375694

Conditions

Hypertension

Cardiovascular Diseases

Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Herbiotics Oral + Ent Probiotic

Placebo

Study Details

Brief 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.

Conditions

Hypertension

Cardiovascular Diseases

Diabetes

Study ID

NCT06375694

Start date

Jun 1, 2024

Status verified date

Jul, 2024

Completion date

May, 2025

Anticipated

Primary completion date

May, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy adult volunteers ages 18-70

Exclusion Criteria:

  • 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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

Interventions

Herbiotics Oral + Ent Probiotic

Chewable Tablets containing Lactobacillus species.

Placebo

Honest Placebo Pills by Zeebo

Primary outcome measure

  • Dietary Nitrate Conversion to Plasma Nitrite [ Time Frame: The two visits will be 8 days apart. ]

Central Contacts and Locations

Central contacts

Daniel B Kim-Shapiro, PhD

336-758-4993shapiro@wfu.edu

Locations

Wake Forest University

Recruiting

Winston-Salem, North Carolina, United States, 27104

Contacts

Daniel Kim-Shapiro, PhD

336-758-4993shapiro@wfu.edu

More Information

Sponsor

Wake Forest University

Last update posted

Jul 19, 2024

Last verified

Jul, 2024

Keywords

  • Nitric Oxide
  • Nitrate
  • Microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University on 2024-07-19.