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Completed

NCT Number: NCT05122689

Dietary Inorganic Nitrate and the Enteral Microbiome

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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Key information

Conditions

Cardiovascular Health

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitrate

Dietary Supplement

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

Control

Dietary Supplement

Dietary sodium-chloride (0,12 mmol sodium-chloride/kg BW/day) dissolved in 200 ml tap water. Supplementation for 30 days.

Primary outcomes

  1. 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

  1. Change of the oral microbiome composition

    Time frame: 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).

  2. Change of circulating SCFA levels

    Time frame: 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.

Other outcomes

  1. Changes in the oral-enteral microbiome axis

    Time frame: 30 days

    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).

  2. Changes in arterial stiffness parameters

    Time frame: 30 days

    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.

  3. Changes in blood pressure

    Time frame: 30 days

    Changes in cardiovascular function measured by systolic and diastolic blood pressure in mmHg at baseline and after 30 days of placebo/verum supplementation.

  4. Change of the nitrate-nitrite-NO metabolism

    Time frame: 30 days

    Changes of nitrate and nitrite content in plasma measured by ENO-20 analysis at baseline and after 30 days of placebo/verum supplementation.

  5. Genetic variants (single nucleotide polymorphism)

    Time frame: 30 days

    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.

  6. Epigenetic changes

    Time frame: 30 days

    Changes of DNA methylation analysis by pyrosequencing at baseline and after 30 days of placebo/verum supplementation.

  7. Changes in TMAO levels

    Time frame: 30 days

    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).

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study title

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

Acronym: DINE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 17, 2021
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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