protocolSection identificationModule nctId: NCT06304480, orgStudyIdInfo id: AFCRO-179, briefTitle: Effect of The Substitution of Animal Protein by Soya-Based Fermented Product on Human Gut Microbiome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: University College Cork, class: OTHER, collaborators name: AIT Austrian Institute of Technology GmbH, descriptionModule briefSummary: There is a growing understanding of the functioning and interconnectedness of microbiomes in the food system which offers great potential for enabling the development of new solutions contributing to achieving important food and nutrition goals including those requested by FOOD 2030. Of relevance in this regard is the provision of sustainable and healthy protein sources. Because of the obvious environmental and climate concerns associated with the production of animal-derived protein, a transition is needed to healthier and more environment-friendly diets, including a moderate-level consumption of red and processed meat and greater emphasis on plant-based foods.As well as impact of meat production on the climate, it is well established that eating a diet rich in red meat promotes the growth of gut microbiome members that drive or exacerbate inflammation. Plant protein does not have these associations, and in fact it is often accompanied by fibre ingestion, which favours growth of health-promoting gut microbes. Replacing meat with plant protein offers the prospect of improving consumer health by improving the gut microbiome. The EU funded project MICROBIOMES4SOY will assess the effect of replacing animal protein with soya-derived protein on the human gut microbiome and whether this replacement can reduce the risk of inflammation-related diseases by gut microbiome modulation. This knowledge will provide a baseline for establishing new dietary pathways making use of soya protein and support dietary transition for EU citizens., conditionsModule conditions: Gut Microbiome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised, open label, controlled, parallel study in healthy males and females., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: Randomised, open label, controlled, parallel study in healthy males and females., enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: 100g fermented Tofu, outcomesModule primaryOutcomes measure: To evaluate the effect of replacing animal protein in a typical Western diet with plant-derived protein delivered in a (soy-based) tofu on gut microbiome composition., secondaryOutcomes measure: To evaluate the functional activity of the gut microbiome, and any alterations caused by the soya replacement., secondaryOutcomes measure: To evaluate the metabolome of urine and faecal samples and any alterations caused by the soya replacement., secondaryOutcomes measure: To measure the effect of the meat substitution on a panel of proinflammatory cytokines, based on the observation that particular taxa are associated with an inflammatory phenotype., secondaryOutcomes measure: To measure the effect of the meat substitution on cholesterol and serum triglycerides., secondaryOutcomes measure: To measure the effect of the meat substitution on blood pressure., secondaryOutcomes measure: To measure the effect of the meat substitution on body mass index (BMI)., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False