Dietary Inorganic Nitrate and the Enteral Microbiome

Not Applicable

Recruiting

• Conditions: Cardiovascular Health
• Interventions: Dietary Supplement: Nitrate; Dietary Supplement: Control

• Registration Number: NCT05122689
• Lead Sponsor: University Hospital, Essen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-11-14
• Study First Posted: 2021-11-17
• Study Start: 2021-11-22
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-23
• Last Update Posted: 2023-06-26
• Primary Completion: 2023-08-12
• Study Completion: 2023-12-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change of the enteral microbiome composition	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 Outcome Measures

Name	Time	Method
Change of the oral microbiome composition	30 days	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).
Change of circulating SCFA levels	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.

Trial Locations

Locations (1)

University Hospital Essen; 🇩🇪 Essen, NRW, Germany