Influence of Exogenous Dietary Inorganic Nitrate on Downstream Metabolites of the Enteral Microbiome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Change of the enteral microbiome composition
Study Overview
Brief Summary
A growing body of data shows that the enteral microbiome has an effect on cardiovascular diseases. Exogenous inorganic dietary nitrate mediates cardioprotective effects and has been shown to have an influence on the oral microbiome. The nutritional aspects of these cardioprotective effects are particularly intriguing since nitrate is abundant in our everyday diet.
Whether dietary nitrate influences the enteral microbiome and downstream metabolites like short-chain fatty acids (SCFA) and TMAO will be investigated in the present study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients aged 40-80 years
- •no regular medication intake
- •no chronic diseases
Exclusion Criteria
- •Regular systemic drug intake
- •Active smoking
- •Chronic diseases
- •Acute diarrhea or vomiting
- •Short gut syndrome
- •Pregnancy or breastfeeding
Arms & Interventions
Nitrate
Dietary inorganic nitrate (0,12 mmol sodium-nitrate/kg BW/day) dissolved in 200 ml tap water. Supplementation for 30 days.
Intervention: Nitrate (Dietary Supplement)
Outcomes
Primary Outcomes
Change of the enteral microbiome composition
Time Frame: 30 days
Changes in enteral microbiome composition in stool samples at baseline and after 30 days of placebo/verum supplementation. The 16S rRNA amplicon reads obtained from an Illumina MiSeq System will be analyzed using pipeline QIIME2 (v. 2019.1).
Secondary Outcomes
- Change of the oral microbiome composition(30 days)
- Change of circulating SCFA levels(30 days)