FOod Additives on the Mucosal Barrier
- Conditions
- Healthy
- Interventions
- Dietary Supplement: Dietary Emulsifier
- Registration Number
- NCT06552156
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Healthy adults
- a BMI between 18.5 - 30 kg/m2
- absence of an eating disorder were required.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Soy Lecithin Dietary Emulsifier Brownies that contained soy lecithin (3.55 g daily, Modernist Pantry, Eliot, ME, USA) Native Rice Starch Dietary Emulsifier Brownies that contained native rice starch (8.72 g daily, Remy B7, BENEO-Remy N.V., Wijgmaal-Leuven, Belgium) Placebo Dietary Emulsifier The intervention was delivered through three daily brownies. These were 'plain' brownies without any further addition next to the basic ingredients. Carboxymethyl Cellulose (CMC) Dietary Emulsifier Brownies that contained carboxymethyl cellulose (2.75 g daily, Modernist Pantry, Eliot, ME, USA) Carrageenan Dietary Emulsifier Brownies that contained k-CGN (375 mg daily, Modernist Pantry, Eliot, ME, USA) Polysorbate-80 (P80) Dietary Emulsifier Brownies that contained polysorbate-80 (1.350 mg daily, Sigma-Aldrich, Darmstad, Germany)
- Primary Outcome Measures
Name Time Method Intestinal inflammation 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) Faecal calprotectin measurement using stool samples (in mg/kg)
Intestinal paracellular permeability measurements Baseline - after the emulsifier-free diet (week 2) - at the end of the trial (week 6) Intestinal permeability measurements using the lactulose mannitol urinary excretion ratio (LMR) using urine samples
Metabolic health - insulin resistance 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) Insulin measurement using blood samples
Intestinal transcellular permeability measurements Baseline - after the emulsifier-free diet (week 2) - - at the end of the trial (week 6) Intestinal transcellular permeability measurements using LPS (lipopolysaccharide)-binding protein (LBP) measurement using blood samples.
Gut microbiome composition 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) Assessment of the gut microbial composition using 16S rRNA sequencing of stool samples.
Gut microbiome metabolism 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) Assessment of the gut microbial metabolism faecal short chain fatty acid (SCFA) measurements from stool samples, including acetic acid, propionic acid, and butyric acid.
Systemic inflammation - inflammatory markers 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) OLINK inflammatory proteomic panel using blood samples
Systemic inflammation - CRP 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) C-reactive protein measurement using blood samples
Metabolic health - lipid profile 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) lipid measurements (including LDL-cholesterol, HDL-cholesterol, total cholesterol and triglycerides) using blood samples
Metabolic health - fasting glucose 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) Fasting glucose measurements using blood samples
Metabolic health - cardiometabolic markers 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) OLINK cardiometabolic proteomic panel using blood samples
Body composition analysis 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) bioelectrical impedance analysis (BIA)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital of Leuven
🇧🇪Leuven, Belgium