protocolSection identificationModule nctId: NCT06311097, orgStudyIdInfo id: M402, briefTitle: Dairy Products to Your Gut and Brain, acronym: YourGutBrain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Copenhagen, class: OTHER, collaborators name: University of Aarhus, collaborators name: APC Microbiome Ireland, descriptionModule briefSummary: The goal of this intervention study is to compare the effects of fermented dairy and non-fermented dairy on bowel habits and cognitive performance in healthy women with defecations every other day or less. Furthermore, the study aims to explore underlying mechanisms linking the gut and the brain.In addition, a sub-study will be conducted to explore differences in gut and brain measures between women with daily (reference group) and few (intervention group) weekly bowel movements, respectively, and to explore associations between measures of gut- and brain function., conditionsModule conditions: Healthy, conditions: Constipation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Two 4-week intervention periods separated by a washout period of at least 4 weeks.The crossover intervention will include 60 participants. Another 40 participants will only complete the first (baseline) visit., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Fermented dairy, interventions name: Non-fermented dairy, outcomesModule primaryOutcomes measure: Difference in change from baseline in defecation frequency between the interventions, secondaryOutcomes measure: Difference in change from baseline in cognitive performance between the interventions, secondaryOutcomes measure: Difference in change from baseline in phase-amplitude coupling between gastric slow-wave activity and cortical alpha activity between the interventions, secondaryOutcomes measure: Difference in change from baseline in whole gut transit time between the interventions, secondaryOutcomes measure: Difference in change from baseline in stool consistency between the interventions, secondaryOutcomes measure: Difference in change from baseline in stool moisture between the interventions, secondaryOutcomes measure: Difference in change from baseline in fecal abundance of Lactobacillus acidophilus between the interventions, secondaryOutcomes measure: Difference in change from baseline in self-reported gastrointestinal symptoms between the interventions, otherOutcomes measure: Difference in change from baseline in gut microbiota between the interventions, otherOutcomes measure: Difference in change from baseline in fecal pH between the interventions, otherOutcomes measure: Difference in change from baseline in breath hydrogen and methane levels between the interventions, otherOutcomes measure: Difference in change from baseline in biomarkers of colonic fermentation between the interventions, otherOutcomes measure: Difference in change from baseline in fecal short-chain fatty acids (SCFAs) between the interventions, otherOutcomes measure: Difference in change from baseline in fecal zonulin levels between the interventions, otherOutcomes measure: Difference in change from baseline in plasma levels of lipopolysaccharide-binding protein (LBP) between the interventions, otherOutcomes measure: Difference in change from baseline in gut metabolome between the interventions, otherOutcomes measure: Difference in change from baseline in urine metabolome between the interventions, otherOutcomes measure: Difference in change from baseline in plasma metabolome between the interventions, otherOutcomes measure: Difference in change from baseline in inflammatory biomarkers between the interventions, otherOutcomes measure: Difference in change from baseline in plasma levels of cortisol between the interventions, otherOutcomes measure: Difference in change from baseline in biomarkers of glucose and lipid metabolism between the interventions, otherOutcomes measure: Difference in change from baseline in appetite hormones between the interventions, otherOutcomes measure: Difference in change from baseline in plasma level of Brain Derived Neurotrophic Factor (BDNF) between the interventions, otherOutcomes measure: Difference in change from baseline in self-reported stress and mood between the interventions, otherOutcomes measure: Difference in change from baseline in self-reported sleeping patterns between the interventions, otherOutcomes measure: Difference in change from baseline in resting-state cortical connectivity between the interventions, otherOutcomes measure: Difference in change from baseline in event-related potentials evoked by a cognitive task between the interventions, otherOutcomes measure: Difference in change from baseline in quality of life between the interventions, otherOutcomes measure: Difference in change from baseline in habitual diet between the interventions, eligibilityModule sex: FEMALE, minimumAge: 45 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Copenhagen, Department of Nutrition, Exercise and Sports, status: RECRUITING, city: Copenhagen, country: Denmark, contacts name: Henrik M Roager, PhD, role: CONTACT, email: hero@nexs.ku.dk, contacts name: Anke Karabanov, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False