Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-30 @ 1:25 PM
Study NCT ID:
NCT06552156
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2024-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FOod Additives on the Mucosal Barrier
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The group assignment was only known by the principal investigator. All other people involved (participants and investigators) were blinded.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double Blind, placebo-controlled, randomised controlled trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2024-08-01', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intestinal inflammation', 'timeFrame': '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)', 'description': 'Faecal calprotectin measurement using stool samples (in mg/kg)'}, {'measure': 'Intestinal paracellular permeability measurements', 'timeFrame': 'Baseline - after the emulsifier-free diet (week 2) - at the end of the trial (week 6)', 'description': 'Intestinal permeability measurements using the lactulose mannitol urinary excretion ratio (LMR) using urine samples'}, {'measure': 'Intestinal transcellular permeability measurements', 'timeFrame': 'Baseline - after the emulsifier-free diet (week 2) - - at the end of the trial (week 6)', 'description': 'Intestinal transcellular permeability measurements using LPS (lipopolysaccharide)-binding protein (LBP) measurement using blood samples.'}, {'measure': 'Gut microbiome composition', 'timeFrame': '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)', 'description': 'Assessment of the gut microbial composition using 16S rRNA sequencing of stool samples.'}, {'measure': 'Gut microbiome metabolism', 'timeFrame': '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)', 'description': 'Assessment of the gut microbial metabolism faecal short chain fatty acid (SCFA) measurements from stool samples, including acetic acid, propionic acid, and butyric acid.'}, {'measure': 'Systemic inflammation - inflammatory markers', 'timeFrame': '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)', 'description': 'OLINK inflammatory proteomic panel using blood samples'}, {'measure': 'Systemic inflammation - CRP', 'timeFrame': '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)', 'description': 'C-reactive protein measurement using blood samples'}, {'measure': 'Metabolic health - lipid profile', 'timeFrame': '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)', 'description': 'lipid measurements (including LDL-cholesterol, HDL-cholesterol, total cholesterol and triglycerides) using blood samples'}, {'measure': 'Metabolic health - insulin resistance', 'timeFrame': '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)', 'description': 'Insulin measurement using blood samples'}, {'measure': 'Metabolic health - fasting glucose', 'timeFrame': '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)', 'description': 'Fasting glucose measurements using blood samples'}, {'measure': 'Metabolic health - cardiometabolic markers', 'timeFrame': '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)', 'description': 'OLINK cardiometabolic proteomic panel using blood samples'}, {'measure': 'Body composition analysis', 'timeFrame': '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)', 'description': 'bioelectrical impedance analysis (BIA)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emulsifiers', 'Dietary emulsifiers', 'Ultra-processed foods'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '40816342', 'type': 'DERIVED', 'citation': 'Wellens 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. 2025 Aug 13:S1542-3565(25)00698-6. doi: 10.1016/j.cgh.2025.08.005. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults\n* a BMI between 18.5 - 30 kg/m2\n* absence of an eating disorder were required.\n\nExclusion Criteria:\n\n* pregnancy and lactation\n* presence of a chronic disease or any known condition resulting in immunosuppression\n* past medical history of any eating disorder\n* irritable bowel syndrome\n* celiac disease\n* IBD or any other chronic intestinal disorders\n* prior abdominal surgery other than appendectomy or cholecystectomy\n* family history of IBD\n* 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\n* antibiotic, prebiotic or probiotic use in the past three months before enrollment\n* presence of food allergies or intolerance to the components of the study diet\n* experienced diarrhoea withing the two weeks prior to screening.'}, 'identificationModule': {'nctId': 'NCT06552156', 'acronym': 'FOAM', 'briefTitle': 'FOod Additives on the Mucosal Barrier', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'FOod Additives on the Mucosal Barrier', 'orgStudyIdInfo': {'id': 'S66308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': "The intervention was delivered through three daily brownies. These were 'plain' brownies without any further addition next to the basic ingredients.", 'interventionNames': ['Dietary Supplement: Dietary Emulsifier']}, {'type': 'EXPERIMENTAL', 'label': 'Carrageenan', 'description': 'Brownies that contained k-CGN (375 mg daily, Modernist Pantry, Eliot, ME, USA)', 'interventionNames': ['Dietary Supplement: Dietary Emulsifier']}, {'type': 'EXPERIMENTAL', 'label': 'Carboxymethyl Cellulose (CMC)', 'description': 'Brownies that contained carboxymethyl cellulose (2.75 g daily, Modernist Pantry, Eliot, ME, USA)', 'interventionNames': ['Dietary Supplement: Dietary Emulsifier']}, {'type': 'EXPERIMENTAL', 'label': 'Polysorbate-80 (P80)', 'description': 'Brownies that contained polysorbate-80 (1.350 mg daily, Sigma-Aldrich, Darmstad, Germany)', 'interventionNames': ['Dietary Supplement: Dietary Emulsifier']}, {'type': 'EXPERIMENTAL', 'label': 'Soy Lecithin', 'description': 'Brownies that contained soy lecithin (3.55 g daily, Modernist Pantry, Eliot, ME, USA)', 'interventionNames': ['Dietary Supplement: Dietary Emulsifier']}, {'type': 'EXPERIMENTAL', 'label': 'Native Rice Starch', 'description': 'Brownies that contained native rice starch (8.72 g daily, Remy B7, BENEO-Remy N.V., Wijgmaal-Leuven, Belgium)', 'interventionNames': ['Dietary Supplement: Dietary Emulsifier']}], 'interventions': [{'name': 'Dietary Emulsifier', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Intervention was delivered by supplying dietary emulsifiers or placebo through 3 brownies a day that participants had to consume.', 'armGroupLabels': ['Carboxymethyl Cellulose (CMC)', 'Carrageenan', 'Native Rice Starch', 'Placebo', 'Polysorbate-80 (P80)', 'Soy Lecithin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospital of Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'João Sabino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leuven University Hospitals'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Upon request', 'ipdSharing': 'YES', 'description': 'Available upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}