Effects of probiotics on nitrate conversion to improve blood flow
Oral Probiotic Effect on Dietary Nitrate to Plasma Nitrite Production
This study is testing if taking probiotics can help improve blood flow by boosting the body's ability to convert dietary nitrate into a substance that supports healthy circulation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Wake Forest University Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT06375694 on ClinicalTrials.gov |
What this trial studies
This study investigates how probiotics can enhance the conversion of dietary nitrate to nitrite, which is then transformed into nitric oxide (NO) in the body. NO is crucial for maintaining healthy blood flow and is linked to various health conditions, including hypertension and cardiovascular diseases. Participants will receive either a probiotic treatment or a placebo, and their blood will be monitored to assess changes in plasma nitrite levels. The research aims to understand the role of the oral microbiome in this conversion process and its implications for cardiovascular health.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18-70 who are not on anticoagulant therapy and do not have a history of difficult blood draws.
Not a fit: Patients with autoimmune diseases that cause dry mouth or those uncomfortable with saliva collection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary strategies for enhancing nitric oxide production, potentially benefiting patients with hypertension and cardiovascular diseases.
How similar studies have performed: Other studies have shown promising results in using dietary nitrate to enhance nitric oxide levels, but the specific role of probiotics in this process is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Daniel B Kim-Shapiro, PhD
- Email: shapiro@wfu.edu
- Phone: 336-758-4993
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.