NCT05122689

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

November 22, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

September 25, 2024

Status Verified

July 1, 2024

Enrollment Period

2.5 years

First QC Date

September 10, 2021

Last Update Submit

September 23, 2024

Conditions

Cardiovascular Health

Keywords

microbiomenitratedietdietary nitratecardiovascular

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change of the oral microbiome composition

    30 days

  • Change of circulating SCFA levels

    30 days

Other Outcomes (7)

  • Changes in the oral-enteral microbiome axis

    30 days

  • Changes in arterial stiffness parameters

    30 days

  • Changes in blood pressure

    30 days

  • +4 more other outcomes

Study Arms (2)

Nitrate

EXPERIMENTAL

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

Dietary Supplement: Nitrate

Control

PLACEBO COMPARATOR

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

Dietary Supplement: Control

Interventions

NitrateDIETARY_SUPPLEMENT

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

Nitrate
ControlDIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 40-80 years
  • no regular medication intake
  • no chronic diseases

You may not qualify if:

  • Regular systemic drug intake
  • Active smoking
  • Chronic diseases
  • Acute diarrhea or vomiting
  • Short gut syndrome
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Related Publications (1)

  • 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.

    PMID: 40804540DERIVED

MeSH Terms

Interventions

Nitrates

Intervention Hierarchy (Ancestors)

AnionsIonsElectrolytesInorganic ChemicalsNitric AcidNitrogen CompoundsOrganic Chemicals

Study Officials

  • Tienush Rassaf, Professor

    Clinic of cardiology and angiology, University Hospital Essen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2021

First Posted

November 17, 2021

Study Start

November 22, 2021

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

September 25, 2024

Record last verified: 2024-07

Locations

DE(1)