Status:
COMPLETED
FOod Additives on the Mucosal Barrier
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- Healthy adults
- a BMI between 18.5 - 30 kg/m2
- absence of an eating disorder were required.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06552156
Start Date
November 1 2022
End Date
June 13 2023
Last Update
August 13 2024
Active Locations (1)
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1
University Hospital of Leuven
Leuven, Belgium