FOod Additives on the Mucosal Barrier
NCT Number: NCT06552156
Acronym: FOAM
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: DIETARY_SUPPLEMENT: Dietary Emulsifier
Sponsor: Universitaire Ziekenhuizen KU Leuven
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2022-11-01
Completion Date: 2023-06-13
Locations: University Hospital of Leuven, Leuven, Belgium

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.

Primary Outcome Measures: Intestinal inflammation, Faecal calprotectin measurement using stool samples (in mg/kg), 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, 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., 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., 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., 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, 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 - CRP, C-reactive protein measurement using blood samples, 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)|Metabolic health - lipid profile, lipid measurements (including LDL-cholesterol, HDL-cholesterol, total cholesterol and triglycerides) using blood samples, 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)|Metabolic health - insulin resistance, Insulin measurement using blood samples, 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)|Metabolic health - fasting glucose, Fasting glucose measurements using blood samples, 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)|Metabolic health - cardiometabolic markers, OLINK cardiometabolic proteomic panel using blood samples, 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)|Body composition analysis, bioelectrical impedance analysis (BIA), 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)