Dietary Inorganic Nitrate and the Enteral Microbiome (DINE)

University Hospital Essen

Status: Completed

Conditions: Cardiovascular Health

Treatments: Dietary Supplement: Control; Dietary Supplement: Nitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT05122689

Dietary nitrate and microbiome

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Nitrate

Experimental group

Description:

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

Treatment:

Dietary Supplement: Nitrate

Control

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Control