Dietary Inorganic Nitrate and the Enteral Microbiome

Cardiovascular Health Clinical Trial

— DINE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05122689
• Other study ID #: Dietary nitrate and microbiome
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2021
• Est. completion date: December 21, 2023

Study information

• Verified date: June 2023
• Source: University Hospital, Essen
• Contact: Christos Rammos, Professor
• Phone: 0201-723
• Email: christos.rammos[@]uk-essen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 21, 2023
• Est. primary completion date: August 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Health

Intervention

Dietary Supplement:
• Nitrate
Dietary inorganic nitrate (0,12 mmol sodium-nitrate/kg BW/day) dissolved in 200 ml tap water. Supplementation for 30 days.
• Control
Dietary sodium-chloride (0,12 mmol sodium-chloride/kg BW/day) dissolved in 200 ml tap water. Supplementation for 30 days.

Locations

Country	Name	City	State
Germany	University Hospital Essen	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Epigenetic changes	Changes of DNA methylation analysis by pyrosequencing at baseline and after 30 days of placebo/verum supplementation.	30 days
Other	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
Primary	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	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
Secondary	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