Dietary Inorganic Nitrate and the Enteral Microbiome

Study Overview
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Brief Summary
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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.

Official Title
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Influence of Exogenous Dietary Inorganic Nitrate on Downstream Metabolites of the Enteral Microbiome

Conditions
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Cardiovascular Health

Intervention / Treatment
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* Dietary Supplement: Nitrate
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitrate<br>Dietary inorganic nitrate (0,12 mmol sodium-nitrate/kg BW/day) dissolved in 200 ml tap water. Supplementation for 30 days. | Dietary Supplement: Nitrate<br>* Dietary inorganic nitrate (0,12 mmol sodium-nitrate/kg BW/day) dissolved in 200 ml tap water. Supplementation for 30 days.<br>|
| Placebo Comparator: Control<br>Dietary sodium-chloride (0,12 mmol sodium-chloride/kg BW/day) dissolved in 200 ml tap water. Supplementation for 30 days. | Dietary Supplement: Control<br>* Dietary sodium-chloride (0,12 mmol sodium-chloride/kg BW/day) dissolved in 200 ml tap water. Supplementation for 30 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the enteral microbiome composition | 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). | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the oral microbiome composition | Changes in oral microbiome composition in oral swabs 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). | 30 days | 
| Change of circulating SCFA levels | Changes in circulating SCFA blood levels at baseline and after 30 days of placebo/verum supplementation will be measured by high-performance liquid chromatography. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microbiome, nitrate, diet, dietary nitrate, cardiovascular