FOod Additives on the Mucosal Barrier

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-06-13

Brief Summary

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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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Detailed Description

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double Blind, placebo-controlled, randomised controlled trial.

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The group assignment was only known by the principal investigator. All other people involved (participants and investigators) were blinded.

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Dietary Emulsifier

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes