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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrate | Experimental | Dietary inorganic nitrate (0,12 mmol sodium-nitrate/kg BW/day) dissolved in 200 ml tap water. Supplementation for 30 days. |
|
| Control | Placebo Comparator | Dietary sodium-chloride (0,12 mmol sodium-chloride/kg BW/day) dissolved in 200 ml tap water. Supplementation for 30 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrate | Dietary Supplement | Dietary inorganic nitrate (0,12 mmol sodium-nitrate/kg BW/day) dissolved in 200 ml tap water. Supplementation for 30 days. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the oral-enteral microbiome axis | Changes in oral-enteral microbiome axis composition in oral swabs and 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tienush Rassaf, Professor | Clinic of cardiology and angiology, University Hospital Essen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Essen | Essen | North Rhine-Westphalia | 45147 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40804540 | Derived | Messiha D, Lange E, Tratnik A, M Westendorf A, Rinke M, Lenz S, Hendgen-Cotta UB, Buer J, Rassaf T, Rammos C. The influence of acute and chronic coronary syndrome on the gut microbiome and downstream microbiome-derived metabolites-Microbiome in acute myocardial infarction-MIAMI-Trial. Basic Res Cardiol. 2025 Oct;120(5):913-924. doi: 10.1007/s00395-025-01134-9. Epub 2025 Aug 13. |
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| ID | Term |
|---|---|
| D009566 | Nitrates |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D017942 |
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| Control | Dietary Supplement | Dietary sodium-chloride (0,12 mmol sodium-chloride/kg BW/day) dissolved in 200 ml tap water. Supplementation for 30 days. |
|
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 |
| Changes in arterial stiffness parameters |
Changes in cardiovascular function measured by arterial stiffness parameters as pulse wave velocity measured in m/s at baseline and after 30 days of placebo/verum supplementation. |
| 30 days |
| Changes in blood pressure | Changes in cardiovascular function measured by systolic and diastolic blood pressure in mmHg at baseline and after 30 days of placebo/verum supplementation. | 30 days |
| Change of the nitrate-nitrite-NO metabolism | Changes of nitrate and nitrite content in plasma measured by ENO-20 analysis at baseline and after 30 days of placebo/verum supplementation. | 30 days |
| Genetic variants (single nucleotide polymorphism) | The effect of the genes NOS3 and GUCY1A3 variation on dietary nitrate response. Genetic polymorphism will be measured by qPCR and analyzed by allelic discrimination. | 30 days |
| Epigenetic changes | Changes of DNA methylation analysis by pyrosequencing at baseline and after 30 days of placebo/verum supplementation. | 30 days |
| Changes in TMAO levels | Changes in TMAO blood levels at baseline and after 30 days of placebo/verum supplementation will be measured by ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS). | 30 days |
| Nitric Acid |
| D017672 | Nitrogen Compounds |
| D009930 | Organic Chemicals |