Clinical trial NCT06552156: FOod Additives on the Mucosal Barrier
Official title: FOod Additives on the Mucosal Barrier
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Emulsifiers
Dietary emulsifiers
Ultra-processed foods
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double Blind, placebo-controlled, randomised controlled trial.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intestinal inflammation
timeFrame: 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)
measure: Intestinal paracellular permeability measurements
timeFrame: Baseline - after the emulsifier-free diet (week 2) - at the end of the trial (week 6)
measure: Intestinal transcellular permeability measurements
timeFrame: Baseline - after the emulsifier-free diet (week 2) - - at the end of the trial (week 6)
measure: Gut microbiome composition
timeFrame: 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)
measure: Gut microbiome metabolism
timeFrame: 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)
measure: Systemic inflammation - inflammatory markers
timeFrame: 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)
measure: Systemic inflammation - CRP
timeFrame: 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)
measure: Metabolic health - lipid profile
timeFrame: 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)
measure: Metabolic health - insulin resistance
timeFrame: 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)
measure: Metabolic health - fasting glucose
timeFrame: 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)
measure: Metabolic health - cardiometabolic markers
timeFrame: 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)
measure: Body composition analysis
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital of Leuven
Study officials:
affiliation: Leuven University Hospitals
name: João Sabino, MD
role: PRINCIPAL_INVESTIGATOR
References: