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Completed

NCT Number: NCT06552156

FOod Additives on the Mucosal Barrier

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Leuven

Leuven, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary Emulsifier

Dietary Supplement

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

Primary outcomes

  1. 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)

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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)

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: FOAM

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 13, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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