FOod Additives on the Mucosal Barrier (FOAM)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Dietary Emulsifier

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • University Hospital of Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 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; Intervention was delivered by supplying dietary emulsifiers or placebo through 3 brownies a day that participants had to consume.
Experimental: Carrageenan; Brownies that contained k-CGN (375 mg daily, Modernist Pantry, Eliot, ME, USA)	Dietary supplement: Dietary Emulsifier; Intervention was delivered by supplying dietary emulsifiers or placebo through 3 brownies a day that participants had to consume.
Experimental: Carboxymethyl Cellulose (CMC); Brownies that contained carboxymethyl cellulose (2.75 g daily, Modernist Pantry, Eliot, ME, USA)	Dietary supplement: Dietary Emulsifier; Intervention was delivered by supplying dietary emulsifiers or placebo through 3 brownies a day that participants had to consume.
Experimental: Polysorbate-80 (P80); Brownies that contained polysorbate-80 (1.350 mg daily, Sigma-Aldrich, Darmstad, Germany)	Dietary supplement: Dietary Emulsifier; Intervention was delivered by supplying dietary emulsifiers or placebo through 3 brownies a day that participants had to consume.
Experimental: Soy Lecithin; Brownies that contained soy lecithin (3.55 g daily, Modernist Pantry, Eliot, ME, USA)	Dietary supplement: Dietary Emulsifier; Intervention was delivered by supplying dietary emulsifiers or placebo through 3 brownies a day that participants had to consume.
Experimental: Native Rice Starch; Brownies that contained native rice starch (8.72 g daily, Remy B7, BENEO-Remy N.V., Wijgmaal-Leuven, Belgium)	Dietary supplement: Dietary Emulsifier; Intervention was delivered by supplying dietary emulsifiers or placebo through 3 brownies a day that participants had to consume.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: João Sabino, MD, Leuven University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): June 13, 2023
• Study Completion (Actual): June 13, 2023

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Ultra-processed foods; Emulsifiers; Dietary emulsifiers
• Other Study ID Numbers: S66308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Available upon request
• IPD Sharing Time Frame: Upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No