FOod Additives on the Mucosal Barrier

NCT06552156 | Completed

• 1 other identifier: S66308
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Emulsifiers; Dietary emulsifiers; Ultra-processed foods

Outcome Measures

Primary Outcomes (12)

• 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)

Study Arms (6)

Placebo

PLACEBO COMPARATOR

The intervention was delivered through three daily brownies. These were 'plain' brownies without any further addition next to the basic ingredients.

Dietary Supplement: Dietary Emulsifier

Carrageenan

EXPERIMENTAL

Brownies that contained k-CGN (375 mg daily, Modernist Pantry, Eliot, ME, USA)

Dietary Supplement: Dietary Emulsifier

Carboxymethyl Cellulose (CMC)

EXPERIMENTAL

Brownies that contained carboxymethyl cellulose (2.75 g daily, Modernist Pantry, Eliot, ME, USA)

Dietary Supplement: Dietary Emulsifier

Polysorbate-80 (P80)

EXPERIMENTAL

Brownies that contained polysorbate-80 (1.350 mg daily, Sigma-Aldrich, Darmstad, Germany)

Dietary Supplement: Dietary Emulsifier

Soy Lecithin

EXPERIMENTAL

Brownies that contained soy lecithin (3.55 g daily, Modernist Pantry, Eliot, ME, USA)

Dietary Supplement: Dietary Emulsifier

Native Rice Starch

EXPERIMENTAL

Brownies that contained native rice starch (8.72 g daily, Remy B7, BENEO-Remy N.V., Wijgmaal-Leuven, Belgium)

Dietary Supplement: Dietary Emulsifier

Interventions

Dietary Emulsifier DIETARY_SUPPLEMENT

Intervention was delivered by supplying dietary emulsifiers or placebo through 3 brownies a day that participants had to consume.

Carboxymethyl Cellulose (CMC); Carrageenan; Native Rice Starch; Placebo; Polysorbate-80 (P80); Soy Lecithin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults
• a BMI between 18.5 - 30 kg/m2
• absence of an eating disorder were required.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospital of Leuven

Leuven, Belgium

Location

Related Publications (1)

• 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. 2025 Aug 13:S1542-3565(25)00698-6. doi: 10.1016/j.cgh.2025.08.005. Online ahead of print.

  PMID: 40816342 DERIVED

Study Officials

• João Sabino, MD

  Leuven University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The group assignment was only known by the principal investigator. All other people involved (participants and investigators) were blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double Blind, placebo-controlled, randomised controlled trial.

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 13, 2024
• Study Start: November 1, 2022
• Primary Completion: June 13, 2023
• Study Completion: June 13, 2023
• Last Updated: August 13, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Upon request

Locations

BE (1)