[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659858":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":32,"armGroups":45,"interventions":56,"overallOfficials":32,"centralContacts":66,"locations":72,"responsibleParty":93,"collaborators":32,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":32,"eligibilityCriteria":101,"healthyVolunteers":102,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":32,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":121,"whyStopped":32,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"University of Reading","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Difference in plasma interleukin-6 (IL-6) concentration between alginate intervention and placebo after 28 days","Plasma interleukin-6 (IL-6) concentration will be measured in plasma from blood samples collected at the end of each 28-day treatment period using a Simple Plex Assay. IL-6 concentration following the alginate intervention will be compared with IL-6 concentration following the placebo period.","From the end of intervention period 1 (28 days) and the end of intervention period 2 (84 days)",[14,17,20,23,26,29],{"measure":15,"description":16,"timeFrame":12},"Difference in gut microbiota composition between alginate and placebo after 28 days","Gut microbiota composition will be assessed from stool samples collected at the end of each 28-day treatment period using 16S sequencing combined with Bacterial Enumerations by FISH-FCM (Fluorescence In Situ Hybridisation with Flow Cytometry). The composition and relative abundance of bacterial taxa following the alginate intervention will be compared with those following the placebo period.",{"measure":18,"description":19,"timeFrame":12},"Difference in faecal calprotectin concentration between alginate intervention and placebo after 28 days","Faecal calprotectin concentration will be measured from stool samples collected at the end of each 28-day treatment period. Calprotectin concentration following the alginate intervention will be compared with that following the placebo period.",{"measure":21,"description":22,"timeFrame":12},"Difference in plasma inflammatory marker concentrations between alginate intervention and placebo after 28 days","Plasma concentrations of IL-10, TNF-a, IL-1b and C- reactive protein using an automated ELISA platform Ella will be measured from blood samples collected at the end of each 28-day treatment period. Concentrations following the alginate intervention will be compared with those following the placebo period.",{"measure":24,"description":25,"timeFrame":12},"Difference in urinary metabolic profile between alginate intervention and placebo after 28 days","Urine samples collected at the end of each 28-day treatment period will be analysed using proton nuclear magnetic resonance (¹H-NMR) spectroscopy to characterise the urinary metabolic profile. The metabolic profiles following the alginate intervention will be compared with those following the placebo period.",{"measure":27,"description":28,"timeFrame":12},"Change in perceived stress score between alginate intervention and placebo after 28 days","Perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10). The PSS-10 produces a total score ranging from 0 to 40, with higher scores indicating greater perceived stress. The change in PSS-10 score from the start to the end of each 28-day treatment period will be compared between the alginate and placebo periods.",{"measure":30,"description":31,"timeFrame":12},"Difference in upper respiratory symptom frequency and severity between alginate intervention and placebo","Upper respiratory symptoms will be assessed using the Wisconsin Upper Respiratory Symptom Survey (WURSS), completed by participants during each 28-day treatment period. The frequency and severity of self-reported upper respiratory symptoms during the alginate intervention will be compared with those during the placebo period. The score each day will be 0 - 161 depending on symptom severity with higher scores indicating higher severity.",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":32,"timePerspective":32,"maskingInfo":38},"RANDOMIZED","CROSSOVER","This is a double-blind, randomised, placebo-controlled crossover study. Participants will be randomly assigned to one of two treatment sequences. Group 1 will receive the intervention for 28 days, followed by a 28-day washout period and then the placebo for 28 days. Group 2 will receive the placebo for 28 days, followed by a 28-day washout period and then the intervention for 28 days.","PREVENTION",{"masking":39,"maskingDescription":32,"whoMasked":40},"QUADRUPLE",[41,42,43,44],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[46,52],{"label":47,"type":6,"description":48,"interventionNames":49},"Alginate-First Sequence","Participants receive the alginate intervention for 28 days, followed by a 28-day washout period and then placebo for 28 days.",[50,51],"Dietary Supplement: Sodium alginate","Dietary Supplement: Placebo (maltodextrin)",{"label":53,"type":6,"description":54,"interventionNames":55},"Placebo-First Sequence","Participants receive placebo for 28 days, followed by a 28-day washout period and then the alginate intervention for 28 days.",[50,51],[57,62],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":32},"DIETARY_SUPPLEMENT","Sodium alginate","5g\u002Fd sodium alginate within a jelly matrix (5g\u002Fd of sodium alginate given as a single serving of flavoured jelly containing the sodium alginate each day)",[47,53],{"type":58,"name":63,"description":64,"armGroupLabels":65,"otherNames":32},"Placebo (maltodextrin)","2g\u002Fd maltodextrin within a jelly matrix ( A placebo flavour and kcal matched jelly given each day containing no sodium alginate)",[47,53],[67],{"name":68,"role":69,"phone":70,"phoneExt":32,"email":71},"Anisha Wijeyesekera","CONTACT","+44 (0) 118 378 6648","a.wijeyesekera@reading.ac.uk",[73],{"facility":5,"status":32,"city":74,"state":32,"zip":32,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Reading","United Kingdom","UK",{"type":78,"coordinates":79},"Point",[80,81],-0.97113,51.45625,{"lat":81,"lon":80},[84,85,89,91],{"name":68,"role":69,"phone":70,"phoneExt":32,"email":71},{"name":86,"role":69,"phone":87,"phoneExt":32,"email":88},"Holly Sedgwick","07535535260","H.sedgwick@pgr.reading.ac.uk",{"name":86,"role":90,"phone":32,"phoneExt":32,"email":32},"SUB_INVESTIGATOR",{"name":68,"role":92,"phone":32,"phoneExt":32,"email":32},"PRINCIPAL_INVESTIGATOR",{"type":92,"investigatorFullName":68,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Associate Professor","100659858","functional-foods-for-health-100659858",false,"NCT07871682","Functional Foods for Health","Assessing the Effects of a Novel Seaweed-containing Functional Food Product on Stress-Associated Immune and Gut Health Outcomes","Inclusion Criteria:\n\nAdults aged 18-50 years. PSS-10 score of 14-27, indicating elevated\u002Fmoderate perceived stress according to the study eligibility criteria.\n\nBMI of 18.5-29.9 kg\u002Fm². Able and willing to provide informed consent. Willing and able to comply with all study procedures and requirements.\n\nExclusion Criteria:\n\nHave a diagnosed vitamin deficiency. Have diabetes. Have heart disease, including a previous stroke or heart attack. Have kidney disease. Have bowel, gastrointestinal, or other gut disease. Have liver disease. Have cancer. Have a diagnosed hormonal abnormality. Have a diagnosed mood disorder, such as depression. Have a diagnosed anxiety disorder, such as generalised anxiety disorder (GAD) or post-traumatic stress disorder (PTSD).\n\nHave taken antibiotics within the previous 3 months. Are pregnant, lactating\u002Fbreastfeeding, or planning to become pregnant within the next 6 months.\n\nHave a food allergy or intolerance that would prevent them from consuming the study products.\n\nAre taking medications for anaemia, high blood pressure, high blood fats, inflammatory conditions, or depression.\n\nAre actively attempting to lose weight. Are currently using weight-loss injections, such as Wegovy (semaglutide) or Mounjaro (tirzepatide).\n\nHave participated in another intervention study within the previous month. Are currently regularly consuming prebiotic or probiotic supplements, or have regularly consumed these supplements within the previous 3 months.\n\nDo not meet the study requirements or are unable\u002Funwilling to comply with study procedures.",true,"ALL","18 Years","50 Years",{"count":107,"type":108},40,"ESTIMATED","INTERVENTIONAL",[111],"NA","The gut plays an important role in supporting the immune system, and certain dietary components such as probiotics (beneficial bacteria) and prebiotics (fibres that feed beneficial bacteria) can help to maintain gut and immune health. Alginate is a natural fibre extracted from brown seaweed that is widely used in foods which may help support beneficial gut bacteria and regulate inflammation. Ongoing psychological stress is known to affect immune function and increase inflammation in the body. This study will investigate whether a daily jelly containing alginate support gut health and improve immune responses compared to a placebo in adults experiencing higher levels of chronic stress.\n\nWe are recruiting participants with elevated chronic stress to assess whether a functional jelly containing alginate, can help to reduce markers of inflammation, by mediating a change in gut microbiota composition.",[114],"Stress, Psychological",[116,117,118,119,120],"Perceived stress","alginate","chronic stress","inflammation","microbiome","NOT_YET_RECRUITING","2026-10-07",{"date":124,"type":125},"2026-10-13","ACTUAL",{"date":127,"type":108},"2026-10-19",{"date":129,"type":108},"2027-04-01",{"name":5,"class":6},1]