Healthy
Conditions
Keywords
Emulsifiers, Dietary emulsifiers, Ultra-processed foods
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.
Interventions
DIETARY_SUPPLEMENTDietary Emulsifier
Intervention was delivered by supplying dietary emulsifiers or placebo through 3 brownies a day that participants had to consume.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The group assignment was only known by the principal investigator. All other people involved (participants and investigators) were blinded.
Intervention model description
Double Blind, placebo-controlled, randomised controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 - 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 |
| 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) |
Countries
Belgium
Outcome results
None listed