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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The intervention was delivered through three daily brownies. These were 'plain' brownies without any further addition next to the basic ingredients. |
|
| Carrageenan | Experimental | Brownies that contained k-CGN (375 mg daily, Modernist Pantry, Eliot, ME, USA) |
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| Carboxymethyl Cellulose (CMC) | Experimental | Brownies that contained carboxymethyl cellulose (2.75 g daily, Modernist Pantry, Eliot, ME, USA) |
|
| Polysorbate-80 (P80) | Experimental | Brownies that contained polysorbate-80 (1.350 mg daily, Sigma-Aldrich, Darmstad, Germany) |
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| Soy Lecithin | Experimental | Brownies that contained soy lecithin (3.55 g daily, Modernist Pantry, Eliot, ME, USA) |
|
| Native Rice Starch |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Emulsifier | Dietary Supplement | Intervention was delivered by supplying dietary emulsifiers or placebo through 3 brownies a day that participants had to consume. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| João Sabino, MD | Leuven University Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Leuven | Leuven | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42105859 | Derived | Wellens J, Luppens M, Hoekx S, Vanderstappen J, Van Elst L, Vissers E, Ferrante M, Verstockt B, Verbeke K, Matthys C, Vermeire S, Sabino J. Feasibility assessment of an emulsifier-free diet in healthy subjects - A sub-analysis of the FOAM trial. Clin Nutr ESPEN. 2026 Aug;74:103321. doi: 10.1016/j.clnesp.2026.103321. Epub 2026 May 7. | |
| 40816342 |
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Available upon request
Upon request
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Double Blind, placebo-controlled, randomised controlled trial.
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The group assignment was only known by the principal investigator. All other people involved (participants and investigators) were blinded.
| Experimental |
Brownies that contained native rice starch (8.72 g daily, Remy B7, BENEO-Remy N.V., Wijgmaal-Leuven, Belgium) |
|
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) |
| Wellens J, Vanderstappen J, Hoekx S, Vissers E, Luppens M, Van Elst L, Lenfant M, Raes J, Derrien M, Verstockt B, Ferrante M, Verbeke K, Matthys C, Vermeire S, Sabino J. Effect of Five Dietary Emulsifiers on Inflammation, Permeability, and the Gut Microbiome: A Placebo-controlled Randomized Trial. Clin Gastroenterol Hepatol. 2026 Apr;24(4):1092-1101. doi: 10.1016/j.cgh.2025.08.005. Epub 2025 Aug 13. |