HealthyFOAMNCT06552156
FOod Additives on the Mucosal Barrier
A study testing Dietary Emulsifier in people with Healthy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dietary Emulsifier
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2022to 13 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
- a BMI between 18.5 - 30 kg/m2
- absence of an eating disorder were required.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Dietary Emulsifier
- Keywords
- Emulsifiers, Dietary emulsifiers, Ultra-processed foods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary EmulsifierDietary supplement
Intervention was delivered by supplying dietary emulsifiers or placebo through 3 brownies a day that participants had to consume.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The intervention was delivered through three daily brownies. These were 'plain' brownies without any further addition next to the basic ingredients. Receives: Dietary Supplement: Dietary Emulsifier |
| Carrageenan | Experimental | Brownies that contained k-CGN (375 mg daily, Modernist Pantry, Eliot, ME, USA) Receives: Dietary Supplement: Dietary Emulsifier |
| Carboxymethyl Cellulose (CMC) | Experimental | Brownies that contained carboxymethyl cellulose (2.75 g daily, Modernist Pantry, Eliot, ME, USA) Receives: Dietary Supplement: Dietary Emulsifier |
| Polysorbate-80 (P80) | Experimental | Brownies that contained polysorbate-80 (1.350 mg daily, Sigma-Aldrich, Darmstad, Germany) Receives: Dietary Supplement: Dietary Emulsifier |
| Soy Lecithin | Experimental | Brownies that contained soy lecithin (3.55 g daily, Modernist Pantry, Eliot, ME, USA) Receives: 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) Receives: Dietary Supplement: Dietary Emulsifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal inflammation
Faecal calprotectin measurement using stool samples (in mg/kg)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Nov 2022
- Primary completion13 Jun 2023
- Study completion13 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double Blind, placebo-controlled, randomised controlled trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- João Sabino, MD, Principal investigator, Leuven University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552156
- Sponsor's protocol ID
- S66308
- Acronym
- FOAM
- Status last verified
- Jul 2024
- First submitted
- 1 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available upon request
Publications
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.
PubMed 42105859Wellens 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.
PubMed 40816342
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOod Additives on the Mucosal Barrier
- ClinicalTrials.gov ID
- NCT06552156
- Acronym / sponsor ID
- FOAM / S66308
- Conditions
- Healthy
- Keywords
- Emulsifiers, Dietary emulsifiers, Ultra-processed foods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Double Blind, placebo-controlled, randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Dietary EmulsifierThe intervention was delivered through three daily brownies. These were 'plain' brownies without any further addition next to the basic ingredients. |
| Carrageenan | Experimental | Dietary Supplement: Dietary EmulsifierBrownies that contained k-CGN (375 mg daily, Modernist Pantry, Eliot, ME, USA) |
| Carboxymethyl Cellulose (CMC) | Experimental | Dietary Supplement: Dietary EmulsifierBrownies that contained carboxymethyl cellulose (2.75 g daily, Modernist Pantry, Eliot, ME, USA) |
| Polysorbate-80 (P80) | Experimental | Dietary Supplement: Dietary EmulsifierBrownies that contained polysorbate-80 (1.350 mg daily, Sigma-Aldrich, Darmstad, Germany) |
| Soy Lecithin | Experimental | Dietary Supplement: Dietary EmulsifierBrownies that contained soy lecithin (3.55 g daily, Modernist Pantry, Eliot, ME, USA) |
| Native Rice Starch | Experimental | Dietary Supplement: Dietary EmulsifierBrownies that contained native rice starch (8.72 g daily, Remy B7, BENEO-Remy N.V., Wijgmaal-Leuven, Belgium) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adults
- a BMI between 18.5 - 30 kg/m2
- absence of an eating disorder were required.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary EmulsifierIntervention was delivered by supplying dietary emulsifiers or placebo through 3 brownies a day that participants had to consume. | Dietary supplement | Carboxymethyl Cellulose (CMC), Carrageenan, Native Rice Starch, Placebo, Polysorbate-80 (P80), Soy Lecithin |
Primary outcome
Intestinal inflammation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Derived from this study: PubMed 42105859Wellens 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.
- Derived from this study: PubMed 40816342Wellens 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.
- Individual participant dataSharing planned: Yes. Available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
João Sabino, MD principal investigator
Leuven University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Emulsifier in people with Healthy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal inflammation (time frame: 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)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06552156, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024; AzTrials last refreshed its copy on 3 Nov 2026.