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NCT06375694 · ClinicalTrials.gov registry record · NA
Probiotic Effect on Dietary Nitrate to Plasma Nitrite Production ( OPEDNPN )
A NA study of Hypertension and Diabetes, sponsored by Wake Forest University.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06375694: Recruiting NA study of Hypertension and Diabetes, sponsored by Wake Forest University.
NCT06375694 is a NA study of Hypertension and Diabetes that is actively recruiting participants, run by Wake Forest University. The registered enrollment target is 20 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06375694, a NA study of Hypertension and Diabetes, is actively recruiting participants, sponsored by Wake Forest University.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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 par
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Herbiotics Oral + Ent Probiotic
Study Locations (1)
North Carolina
- Wake Forest University - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-06-01 |
| Est. Completion | 2025-05 |
| Phase | NA |
What NCT06375694 shows while recruiting
NCT06375694 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06375694 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06375694 about?
NCT06375694 is a clinical study titled "Probiotic Effect on Dietary Nitrate to Plasma Nitrite Production ( OPEDNPN )". 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 th...
What is the current status of trial NCT06375694?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2024-06-01. Estimated completion is 2025-05.
What conditions does trial NCT06375694 study?
This clinical trial studies the following conditions: Hypertension, Diabetes, Cardiovascular Diseases.
What interventions are being tested in trial NCT06375694?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Herbiotics Oral + Ent Probiotic (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06375694?
This trial is sponsored by Wake Forest University, which has 100 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06375694 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06375694's enrollment target sits among peer trials
20 438th of 470 higher than 24 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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