FOod Additives on the Mucosal Barrier (FOAM)

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Dietary Emulsifier

Study type: Interventional

Funder types: Other

Identifiers

NCT06552156

S66308

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Dietary Emulsifier

Carrageenan

Experimental group

Description:

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

Treatment:

Dietary Supplement: Dietary Emulsifier

Carboxymethyl Cellulose (CMC)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Dietary Emulsifier

Polysorbate-80 (P80)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Dietary Emulsifier

Soy Lecithin

Experimental group

Description:

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

Treatment:

Dietary Supplement: Dietary Emulsifier

Native Rice Starch

Experimental group

Description:

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

Treatment:

Dietary Supplement: Dietary Emulsifier