[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657313":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":37,"studyPopulation":27,"armGroups":38,"interventions":56,"overallOfficials":69,"centralContacts":75,"locations":81,"responsibleParty":97,"collaborators":27,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":27,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":27,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":83,"whyStopped":27,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"University of Bath","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"Area Under the Curve (AUC) of Breath Hydrogen and Methane Production","Total colonic fermentation yield is evaluated by measuring breath hydrogen and methane concentrations. Breath samples are collected at 30-minute intervals post-intervention using Omed breath analysers. The total production for both gases is quantified independently by calculating their respective AUC values from the averaged concentration-time profiles.","Baseline (fasting) and every 30 minutes up to 8 hours on each acute test day",[14,18,21,24],{"measure":15,"description":16,"timeFrame":17},"Fermentation Kinetic Parameters: Maximum Peak Concentration (Cmax) of Breath Gases","The dynamic temporal characteristics of gut fermentation are evaluated by determining the maximum peak concentration (Cmax) for both breath hydrogen and methane. Data is extracted from continuous breath samples collected using Omed breath analysers.","Baseline (fasting) and every 30 minutes up to 8 hours on each acute test day.",{"measure":19,"description":20,"timeFrame":17},"Fermentation Kinetic Parameters: Time to Peak (Tmax) of Breath Gases","The dynamic temporal characteristics of gut fermentation are evaluated by determining the time required to reach this peak concentration (Tmax) for both breath hydrogen and methane. Data is extracted from continuous breath samples collected using Omed breath analysers.",{"measure":22,"description":23,"timeFrame":17},"Acute Gastrointestinal (GI) Tolerability Composite Score","The incidence and severity of subjective GI symptoms (bloating, abdominal cramping, stomach noises\u002Fborborygmi, and flatulence) are rated by participants on a scale from 0 (absent) to 10 (extremely severe). Any bowel movements are logged and converted into a stool score from 0 (normal transit) to 10 (diarrhoea). These are summed to calculate a total composite score ranging from 0 to 50, with higher scores indicating worse GI tolerability.",{"measure":25,"description":26,"timeFrame":17},"Lower Gastrointestinal Response Assessed by the Bristol Stool Scale (BSS)","Participants monitor and log their daily bowel movement frequency and utilise the Bristol Stool Scale (BSS) to objectively assess stool consistency and appearance. This tracks delayed lower gastrointestinal responses beyond the immediate acute testing window.",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"RANDOMIZED","CROSSOVER","BASIC_SCIENCE",{"masking":33,"maskingDescription":27,"whoMasked":34},"DOUBLE",[35,36],"PARTICIPANT","INVESTIGATOR","This study aims to investigate the effect of rapidly fermenting FOS over-and-above slowly fermenting SCF and whether this supports a \"spatio-temporal fermentation profile\" spanning the entire colonic tract. By balancing fermentation speeds, this strategy holds the potential to maximise total colonic fermentation yield whilst mitigating the adverse symptoms typically associated with isolated high-dose FOS intake. Furthermore, the study explores a split-dosing regimen as an additional temporal strategy; dividing the FOS intake may limit the peak rate of gas production, preventing it from exceeding the gut's natural gas clearance mechanisms, while ensuring a sustained delivery of fermentable substrates.\n\nTo evaluate these physiological dynamics, healthy adult participants will complete a randomised, double-blind, crossover trial comprising three distinct acute testing days, separated by 7-day washout periods. Under strict dietary standardisation and overnight fasting conditions, participants will consume meals containing specific dietary fibres. The acute physiological responses will be continuously monitored via non-invasive breath hydrogen and methane analysis to objectively map fermentation kinetics, alongside regular self-reported assessments of gastrointestinal tolerability throughout the testing window.",[39,45,51],{"label":40,"type":41,"description":42,"interventionNames":43},"SCF Alone","ACTIVE_COMPARATOR","Participants will consume a standardised breakfast containing SCF in the drink component. Three hours later, they will consume a standardised low-fibre lunch.",[44],"Dietary Supplement: SCF Alone",{"label":46,"type":47,"description":48,"interventionNames":49},"Single Combined Dose (SCF + FOS)","EXPERIMENTAL","Participants will consume a standardised breakfast containing SCF in the drink component. They will also consume a meal containing a full dose of FOS. Three hours later, they will consume a standardized low-fibre lunch.",[50],"Dietary Supplement: SCF and FOS (Single Dose)",{"label":52,"type":47,"description":53,"interventionNames":54},"Split-Dosed Combination (SCF + FOS)","Participants will consume a standardised breakfast containing SCF in the drink component. They will also consume a meal containing half the dose of FOS. Three hours later, they will consume a standardized low-fibre lunch containing the other half of the dose of FOS.",[55],"Dietary Supplement: SCF and FOS (Split Dose)",[57,61,65],{"type":58,"name":40,"description":59,"armGroupLabels":60,"otherNames":27},"DIETARY_SUPPLEMENT","Administration of SCF with breakfast.",[40],{"type":58,"name":62,"description":63,"armGroupLabels":64,"otherNames":27},"SCF and FOS (Single Dose)","Administration of FOS as a single dose over-and-above SCF with breakfast.",[46],{"type":58,"name":66,"description":67,"armGroupLabels":68,"otherNames":27},"SCF and FOS (Split Dose)","Administration of FOS at breakfast and at lunch, over-and-above SCF at breakfast.",[52],[70,73],{"name":71,"affiliation":5,"role":72},"Dylan Thompson, Dr.","PRINCIPAL_INVESTIGATOR",{"name":74,"affiliation":5,"role":72},"Oly Perkin, Dr.",[76],{"name":77,"role":78,"phone":79,"phoneExt":27,"email":80},"Kuan-Yu Lin","CONTACT","+44 7799056885","kyl205@bath.ac.uk",[82],{"facility":5,"status":83,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"RECRUITING","Bath","Somerset","BA2 7AY","United Kingdom","UK",{"type":90,"coordinates":91},"Point",[92,93],-2.36172,51.3751,{"lat":93,"lon":92},[96],{"name":77,"role":78,"phone":79,"phoneExt":27,"email":80},{"type":72,"investigatorFullName":77,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PhD researcher","100657313","dietary-fibres-on-gut-fermentation-100657313",false,"NCT07837297","Dietary Fibres on Gut Fermentation","Acute Effects of Different Dietary Fibres on Gut Fermentation: A Pilot Study","Inclusion Criteria:\n\n* Healthy males and females, aged between 18 and 85 years at the start of the study.\n* Self-reported regular bowel habits, defined as an average frequency of between 3 and 21 bowel movements per week (Mitsuhashi et al., 2018). This weekly average accounts for normal daily fluctuations while ensuring an overall healthy baseline.\n* Willing and able to comply with all study protocols, including pre-test dietary restrictions (avoiding highly fermentable foods), a 12-hour overnight fast, and consumption of the prescribed dietary fibre test meals.\n* Willing to accurately record gastrointestinal symptoms using the Visual Analogue Scale (VAS) and complete the Bristol Stool Scale (BSS) logs over the specified periods.\n* Able to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* History or current diagnosis of chronic gastrointestinal diseases or conditions (e.g., Irritable Bowel Syndrome \\[IBS\\], Inflammatory Bowel Disease \\[IBD\\], coeliac disease, chronic constipation, or history of major gastrointestinal surgery).\n* Use of systemic antibiotics, prebiotics, probiotics, or medications known to significantly alter gastrointestinal motility within the 3 months prior to the commencement of, or during the study period.\n* Known food allergies or severe intolerances to any ingredients present in the test meals (e.g., soluble corn fibre, fructo-oligosaccharides).\n* Females who are currently pregnant, planning to become pregnant during the study period, or lactating.\n* Currently following a highly restrictive or extreme diet (e.g., strict ketogenic, extreme high-fibre, or medically prescribed diets) that could significantly confound the baseline gut microbiota or fermentation profile.",true,"ALL","18 Years","85 Years",{"count":111,"type":112},20,"ESTIMATED","INTERVENTIONAL",[115],"NA","The goal of this clinical trial is to learn if adding a rapidly fermenting fibre to a meal containing a slow fermenting fibre affects gut bacterial fermentation and digestive comfort in healthy adults aged 18 to 85 years. The main questions it aims to answer are:\n\n* Does the addition of a fast fermenting fibre to a meal containing a slow fermenting fibre change the timing and amount of gas produced by gut bacterial fermentation?\n* Does the addition of a fast fermenting fibre as a split dose effectively reduce the digestive discomfort typically caused by consuming a high dose of fibre all at once?\n\nResearchers will compare the effect of adding fructo-oligosaccharides (FOS) over-and-above a single dietary fibre (soluble corn fibre). They will also compare whether taking FOS either all at once versus splitting it into two smaller doses affects gut bacterial fermentation and digestive comfort.\n\nParticipants will:\n\n* Visit the research laboratory for 3 test days, with a 1-week break between visits.\n* Avoid certain foods and fast overnight before each test day.\n* Eat a test breakfast and lunch containing the dietary fibres in different parts of the meal.\n* Provide breath samples every 30 minutes to measure gas produced by gut bacteria.\n* Answer survey questions about their digestive comfort every 30 minutes.\n* Keep a diary of their bowel movements for 5 days during each test cycle.\n\nShort-chain fatty acids (SCFAs) produced through dietary fibre fermentation are essential for maintaining intestinal barrier integrity and regulating systemic metabolism; however, average daily fibre intake frequently remains below recommended levels. While supplementing with highly fermentable fibres, such as fructo-oligosaccharides (FOS), effectively stimulates beneficial microbial activity in the proximal colon, their rapid breakdown often triggers acute gastrointestinal discomfort, including bloating and flatulence. Conversely, soluble corn fibre (SCF) possesses a highly branched structure that ferments slowly and reaches the distal colon, exhibiting excellent gastrointestinal tolerability but yielding a lower initial peak of SCFA production.",[118],"Healthy Adult",[120,121,122,123,124],"Dietary Fibre","Fructo-oligosaccharides","Gastrointestinal Tolerability","Short-Chain Fatty Acids","Soluble Corn Fibre","2026-09-19",{"date":127,"type":128},"2026-09-23","ACTUAL",{"date":130,"type":112},"2026-08-26",{"date":132,"type":112},"2027-08-27",{"name":5,"class":6},1]