protocolSection identificationModule nctId: NCT06333717, orgStudyIdInfo id: Dnr 2020-03709, briefTitle: Impact of Whole Grain Rye Bread on Health, acronym: FBS, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-03-03, primaryCompletionDateStruct date: 2021-03-03, completionDateStruct date: 2021-11-05, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Örebro University, Sweden, class: OTHER, descriptionModule briefSummary: This randomized controlled trial aims to study how a high intake of a fibre-rich bread affects the composition and functioning of the gut microbiota in healthy subjects, and how this, in turn, impacts on the release of gut peptides, intestinal permeability, stress and cognitive performance., conditionsModule conditions: Healthy Diet, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: double blinding, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 33, type: ACTUAL, armsInterventionsModule interventions name: Whole grain bread, interventions name: Control bread, outcomesModule primaryOutcomes measure: Microbiota composition baseline vs after intervention using 16S RNA gene sequencing, secondaryOutcomes measure: Microbiota composition whole grain rye bread vs control bread using 16S RNA gene sequencing, secondaryOutcomes measure: Concentrations of circulatory short-chain fatty acids SCFA, secondaryOutcomes measure: Concentrations of faecal SCFA, secondaryOutcomes measure: Concentrations of blood glucagon like peptide-1 (GLP-1), secondaryOutcomes measure: Concentrations of blood glucagon like peptide-2 (GLP-2), secondaryOutcomes measure: Concentrations of blood peptide YY (PYY), secondaryOutcomes measure: Concentrations of blood gastric inhibitory polypeptide (GIP), secondaryOutcomes measure: Concentrations of blood neuroactive peptide Y (NPY), secondaryOutcomes measure: Concentrations of blood brain-derived neurotrophic factor (BDNF), secondaryOutcomes measure: Concentrations of blood cytokines, secondaryOutcomes measure: Concentrations of blood alkylresorcinols, secondaryOutcomes measure: Concentrations of blood lipopolysaccharide-binding protein (LBP), secondaryOutcomes measure: Concentrations of blood soluble CD-14 (sCD-14), secondaryOutcomes measure: Concentrations of sugars in urine, secondaryOutcomes measure: Concentrations of saliva cortisol during stress test, secondaryOutcomes measure: Concentrations of saliva alpha-amylase during stress test, otherOutcomes measure: Gastrointestinal symptoms measured by Gastrointestinal Symptom Rating Scale in Irritable Bowel Syndrome (GSRS-IBS), otherOutcomes measure: Food habits measured by an electronic food frequency questionnaire Mealq, otherOutcomes measure: Food habits measured by a Food diary, otherOutcomes measure: Physical activity measured by the International Physical Activity Questionnaire (IPAQ), otherOutcomes measure: Quality of life measured by the Euro Quality of Life questionnaire, otherOutcomes measure: Perceived stress measured by a Visual analog scale questionnaire, otherOutcomes measure: Cognitive control using Eriksen flanker task (Flanker task), otherOutcomes measure: Working memory performance using a modified N-back task combined with recent-probes item-recognition task (Sternberg task), otherOutcomes measure: Electrocardiogram (ECG) using the Biopac system, otherOutcomes measure: Electrodermal activity (EDA) using the Biopac system, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 44 Years, stdAges: ADULT, contactsLocationsModule locations facility: Örebro University, city: Örebro, country: Sweden, geoPoint lat: 59.27412, lon: 15.2066, hasResults: False