FOod Additives on the Mucosal Barrier

Universitaire Ziekenhuizen KU Leuven60 enrolled

Overview

This is a 6-week pilot study in 60 healthy volunteers to explore (1) the effect of an emulsifier-free diet (2) the effect of three dietary emulsifiers which are believed to detrimentally affect human health, (3) and the effect of two neutral alternatives (native rice starch and soy lecithin), compared to placebo on intestinal permeability and inflammation, systemic inflammation, and the gut microbiota.

This is a 6-week randomized, double-blind placebo-controlled pilot study in 60 healthy volunteers to explore (1) the effect of an emulsifier-free diet (2) the effect of dietary emulsifiers carrageenan, CMC, and Polysorbate-80 (which are believed to detrimentally affect human health), (3) and the effect of neutral alternatives (native rice starch and soy lecithin) on intestinal permeability and inflammation, systemic inflammation, and the gut microbiota.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

Dietary EmulsifierDIETARY_SUPPLEMENT

Intervention was delivered by supplying dietary emulsifiers or placebo through 3 brownies a day that participants had to consume.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy adults * a BMI between 18.5 - 30 kg/m2 * absence of an eating disorder were required. Exclusion Criteria: * pregnancy and lactation * presence of a chronic disease or any known condition resulting in immunosuppression * past medical history of any eating disorder * irritable bowel syndrome * celiac disease * IBD or any other chronic intestinal disorders * prior abdominal surgery other than appendectomy or cholecystectomy * family history of IBD * current use of non-steroidal anti-inflammatory drugs (NSAIDs), laxatives, anti-diarrheal medication, anticholinergic medications, narcotics, antacids, proton pump inhibitors (PPIs), or dietary supplements that could not be stopped four weeks before the start of the trial * antibiotic, prebiotic or probiotic use in the past three months before enrollment * presence of food allergies or intolerance to the components of the study diet * experienced diarrhoea withing the two weeks prior to screening.

Locations (1)

University Hospital of Leuven

Leuven, Belgium

Outcomes

Primary Outcomes

Intestinal inflammation

Faecal calprotectin measurement using stool samples (in mg/kg)

Time frame: Baseline - after the emulsifier-free diet (week 2) - after 2 weeks of the supplementation and the emulsifier-free diet (week 4) - at the end of the trial (week 6)

Intestinal paracellular permeability measurements

Intestinal permeability measurements using the lactulose mannitol urinary excretion ratio (LMR) using urine samples

Time frame: Baseline - after the emulsifier-free diet (week 2) - at the end of the trial (week 6)

Intestinal transcellular permeability measurements

Intestinal transcellular permeability measurements using LPS (lipopolysaccharide)-binding protein (LBP) measurement using blood samples.

Time frame: Baseline - after the emulsifier-free diet (week 2) - - at the end of the trial (week 6)

Gut microbiome composition

Assessment of the gut microbial composition using 16S rRNA sequencing of stool samples.

Time frame: Baseline - after the emulsifier-free diet (week 2) - after 2 weeks of the supplementation and the emulsifier-free diet (week 4) - at the end of the trial (week 6)

Gut microbiome metabolism

Assessment of the gut microbial metabolism faecal short chain fatty acid (SCFA) measurements from stool samples, including acetic acid, propionic acid, and butyric acid.

Time frame: Baseline - after the emulsifier-free diet (week 2) - after 2 weeks of the supplementation and the emulsifier-free diet (week 4) - at the end of the trial (week 6)

Systemic inflammation - inflammatory markers

OLINK inflammatory proteomic panel using blood samples

Time frame: Baseline - after the emulsifier-free diet (week 2) - after 2 weeks of the supplementation and the emulsifier-free diet (week 4) - at the end of the trial (week 6)

Data from ClinicalTrials.gov

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