[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659456":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":42,"studyPopulation":37,"armGroups":43,"interventions":54,"overallOfficials":59,"centralContacts":63,"locations":68,"responsibleParty":84,"collaborators":37,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":37,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":112,"overallStatus":70,"whyStopped":37,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Western Norway University of Applied Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":22},[9,13],{"measure":10,"description":11,"timeFrame":12},"Changes in gut microbiota alpha diversity.","Change in gut microbiota alpha diversity assessed by the Shannon Diversity Index using precision microbiome profiling (PMP) of stool samples.","From baseline to the end of intervention at 4 weeks.",{"measure":14,"description":15,"timeFrame":16},"Changes in gut microbiota composition","Change in the relative abundance of selected bacteria measured by precision microbiome profiling (PMP) of stool samples.","From baseline to end of intervention at 4 weeks",[18],{"measure":19,"description":20,"timeFrame":21},"Changes in circulating metabolite concentrations","Change in concentrations of microbiome-related metabolites measured by targeted metabolomics using the Microbiome Panel (Bevital AS) in blood samples.","From baseline to end of intervention at 4 weeks.",[23,26,29],{"measure":24,"description":25,"timeFrame":21},"Dietary intake","Dietary intake assessed by structured dietary interviews (48 hour recall)",{"measure":27,"description":28,"timeFrame":21},"Physical activity level","Physical activity level assessed by structured interview covering the previous two weeks and expressed as MET-hours per week.",{"measure":30,"description":31,"timeFrame":21},"Body weight","Body weight measured in kilograms (kg).",{"allocation":33,"interventionModel":34,"interventionModelDescription":35,"primaryPurpose":36,"observationalModel":37,"timePerspective":37,"maskingInfo":38},"RANDOMIZED","PARALLEL","Participants will be randomized using sex-stratified randomization to either an intervention group or a control group. The intervention group will consume a standardized daily breakfast consisting of barley (70 g dry weight) and kefir (200 mL) for four weeks, while the control group will maintain their habitual diet without receiving the dietary intervention. Both groups will be asked to maintain their usual dietary habits and training routines throughout the study period. Outcome measures will be assessed at baseline and after four weeks.","BASIC_SCIENCE",null,{"masking":39,"maskingDescription":37,"whoMasked":40},"SINGLE",[41],"OUTCOMES_ASSESSOR","The human gut microbiota is increasingly recognized as an important contributor to metabolic regulation, immune function, and overall health. A diverse and functionally balanced gut microbiota has been associated with favourable metabolic and health outcomes, while alterations in microbial composition have been linked to a range of physiological and pathological conditions. Emerging evidence suggests that the gut microbiota may also play a role in biological processes relevant to exercise adaptation, recovery, and physical performance.\n\nPhysically active individuals participating in endurance sports may represent a particularly interesting population for microbiome research. Previous studies suggest that highly trained individuals can exhibit distinct gut microbiota profiles compared with less active populations. At the same time, considerable inter-individual variation exists, and further research is needed to better understand how dietary factors may influence gut microbiota composition and function in this population.\n\nDiet is one of the most important determinants of gut microbiota composition. The present study focuses on a practical dietary strategy based on two commonly available food products with potential microbiota-modulating properties. Barley is rich in dietary fibre, including beta-glucans and other prebiotic components that may stimulate the growth and metabolic activity of beneficial gut microbiota. Kefir is a fermented dairy product containing probiotic lactic acid bacteria and other microorganisms that may influence microbial composition and function. Both foods have demonstrated biological effects in previous studies and represent a realistic dietary intervention with potential applicability beyond a research setting.\n\nThe study is designed as a randomized controlled parallel-group intervention trial. Participants will be randomly allocated to either an intervention group or a control group using sex-stratified randomization to ensure balanced representation of men and women across study groups. The intervention group will consume a standardized breakfast consisting of barley porridge (70 g dry weight) and kefir (200 mL) daily for four weeks. Participants assigned to the control group will continue their habitual diet without receiving the dietary intervention. All participants will be asked to maintain their usual dietary habits and training routines throughout the study period.\n\nGut microbiota will be characterized using Precision Microbiome Profiling (PMP), a quantitative PCR-based analytical platform capable of quantifying approximately 100 microbial taxa representative of the human gut microbiome. Analyses will focus on changes in alpha diversity, assessed by the Shannon Diversity Index, as well as changes in the relative abundance of selected bacterial taxa.\n\nBlood and urine samples will be analysed using metabolomics approaches to characterize metabolites associated with gut microbial activity and energy metabolism. Particular attention will be given to metabolites that may reflect interactions between the gut microbiota and host physiology. As gut microbiota-derived metabolites can enter the systemic circulation and act as signalling molecules between microbial communities and host tissues, metabolite profiling may contribute to a better understanding of potential biological mechanisms linking dietary intake, microbial activity, and systemic metabolism.\n\nData collection will be performed at baseline and after four weeks. Biological sampling will include stool samples for microbiota analyses and blood and urine samples for metabolomics analyses. Additional data collection will include dietary interviews, body weight measurements, and registration of training volume and training load. These measures will provide contextual information for the interpretation of microbiota and metabolomics data and help account for potential confounding factors.\n\nUp to 80 participants will be included in the study. The planned sample size is based on expected changes in gut microbiota diversity reported in previous dietary intervention studies and takes anticipated participant attrition into account. The study is designed to evaluate the effects of a feasible and low-risk dietary intervention on gut microbiota diversity, microbial composition, and metabolite profiles in physically active adults.\n\nChanges from baseline to week 4 will be compared between the intervention and control groups. Analyses will focus on measures of gut microbiota alpha diversity, microbial composition, and circulating and urinary metabolites. Repeated-measures statistical approaches will be used to account for within-participant changes over time and to evaluate differences between study groups.\n\nThe study seeks to improve understanding of the relationships among diet, gut microbiota, and systemic metabolism in physically active adults. The findings may contribute to the development of evidence-based dietary strategies aimed at supporting health, recovery, and physiological adaptation through modulation of the gut microbiota.",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"Intervention arm","EXPERIMENTAL","Participants will consume a standardized daily breakfast consisting of barley (70 g dry weight) and kefir (200 mL) for four weeks while maintaining their habitual diet and training routines.",[49],"Other: Barley and kefir dietary intervention",{"label":51,"type":52,"description":53,"interventionNames":37},"Control arm","NO_INTERVENTION","Participants will maintain their habitual diet and training routines throughout the four-week study period.",[55],{"type":6,"name":56,"description":57,"armGroupLabels":58,"otherNames":37},"Barley and kefir dietary intervention","Daily consumption of a standardized breakfast consisting of barley (70 g dry weight) and kefir (200 mL) for four weeks.",[45],[60],{"name":61,"affiliation":5,"role":62},"Iselin T Vildmyren, PhD","PRINCIPAL_INVESTIGATOR",[64],{"name":61,"role":65,"phone":66,"phoneExt":37,"email":67},"CONTACT","+4798699287","isvi@hvl.no",[69],{"facility":5,"status":70,"city":71,"state":37,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"RECRUITING","Bergen","5225","Norway","NO",{"type":76,"coordinates":77},"Point",[78,79],5.32415,60.39299,{"lat":79,"lon":78},[82],{"name":61,"role":65,"phone":83,"phoneExt":37,"email":67},"+47 55 58 72 04",{"type":62,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"Iselin Thowsen Vildmyren","Associate Professor","100659456","effects-of-barley-and-kefir-on-gut-microbiota-in-physically-active-adults-100659456",false,"NCT07864779","Effects of Barley and Kefir on Gut Microbiota in Physically Active Adults","Effects of a Four-Week Dietary Intervention With Barley and Kefir on Gut Microbiota, Circulating Metabolites, and Health Outcomes in Physically Active Adults: A Randomized Controlled Trial","GUTS","Inclusion Criteria:\n\n* Adults aged 18 - 55 years\n* High aerobic capacity defined by the following minimum estimated VO₂max values:\n\nMen:\n\n* 20-29 years: ≥ 51 mL\u002Fkg\u002Fmin\n* 30-39 years: ≥ 47 mL\u002Fkg\u002Fmin\n* 40-49 years: ≥ 43 mL\u002Fkg\u002Fmin\n* 50-55 years: ≥ 38 mL\u002Fkg\u002Fmin\n\nWomen:\n\n* 20-29 years: ≥ 44 mL\u002Fkg\u002Fmin\n* 30-39 years: ≥ 40 mL\u002Fkg\u002Fmin\n* 40-49 years: ≥ 36 mL\u002Fkg\u002Fmin\n* 50-55 years: ≥ 32 mL\u002Fkg\u002Fmin\n\nExclusion Criteria:\n\n* Pregnancy\n* Ulcerative colitis\n* Crohn's disease\n* Coeliac disease\n* Milk allergy\n* Lactose intolerance\n* Use of antibiotics within the previous 6 months",true,"ALL","18 Years","55 Years",{"count":100,"type":101},80,"ESTIMATED","INTERVENTIONAL",[104],"NA","The purpose of this randomized controlled clinical trial is to investigate whether a four-week dietary intervention consisting of a daily meal with barley and kefir can influence gut microbiota diversity and composition in physically active adults participating in endurance sports. The study will further examine whether diet-induced changes in the gut microbiota are associated with changes in relevant circulating and urinary metabolites.\n\nGrowing evidence indicates that the gut microbiota plays an important role in metabolism, immune function, and overall health. Dietary factors are among the most important modulators of gut microbial composition. Barley contains dietary fibre including beta-glucans and other prebiotic components that may promote the growth of beneficial bacteria, while kefir contains live probiotic lactic acid bacteria that may influence both microbial composition and function. However, there is limited knowledge regarding how practical and realistic dietary interventions affect gut microbiota and host biological responses in physically active adults.\n\nThe primary objectives of the study are to determine whether daily consumption of a standardized meal consisting of barley porridge (70 g) and kefir (200 mL) for four weeks alters gut microbiota alpha diversity and gut microbiota composition compared with maintaining a habitual diet.\n\nSecondary objectives are to investigate whether changes in gut microbiota are associated with changes in circulating and urinary metabolite profiles related to gut microbiota activity and energy metabolism.\n\nPhysically active participants aged 18 to 55 will be recruited and randomized to either an intervention group or a control group. Participants assigned to the intervention group will consume a daily breakfast consisting of barley porridge and kefir for four weeks. Participants assigned to the control group will maintain their habitual diet without receiving the dietary intervention. Both groups will be asked to maintain their usual dietary practices and training routines throughout the study period.\n\nData collection will be performed at baseline and after four weeks and will include stool samples, blood samples, urine samples, dietary interviews, and recording of training volume and training load. Stool samples will be analyzed using Precision Microbiome Profiling (PMP) to characterize gut microbiota diversity and composition. Blood and urine samples will be analyzed using metabolomics approaches to assess circulating and urinary metabolites.\n\nThe study aims to provide a comprehensive understanding of the relationships among diet, gut microbiota, metabolite profiles, and cellular responses in physically active adults, and to generate new knowledge regarding biological mechanisms that may be relevant for health, recovery, and physical performance.",[107,108,109,110,111],"Gut Microbiota Diversity and Composition","Gut Microbiota Modulation","Probiotic","Prebiotic","Metabolomics",[113,114,115,116,117,118,119,109,110,111,120,121,122],"Gut microbiota","Gut microbiota diversity","Gut microbiota composition","Gut microbiota modulation","Dietary intervention","Barley","Kefir","Energy metabolism","Endurance exercise","Physically active adults","2026-10-01",{"date":125,"type":126},"2026-10-08","ACTUAL",{"date":128,"type":126},"2026-09-07",{"date":130,"type":101},"2031-06",{"name":5,"class":6},1]