[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622774":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":61,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":26,"overallStatus":85,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Lindenwood University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Postbiotic","EXPERIMENTAL","Participants assigned to the postbiotic group will consume a multi-strain postbiotic supplement daily for 28 consecutive days prior to completing a standardized treadmill exercise bout. The supplement will be provided in capsule form and consumed once daily with approximately eight ounces of water.",[13],"Dietary Supplement: Multi-Strain Postbiotic",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants assigned to the placebo group will consume a placebo consisting of microcrystalline cellulose in capsule form daily for 28 consecutive days prior to completing a standardized treadmill exercise bout. The placebo capsules will be identical in size, color, and appearance to the postbiotic capsules and will be consumed once daily with approximately eight ounces of water.",[19],"Dietary Supplement: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Multi-Strain Postbiotic","Participants will ingest a multi-strain postbiotic supplement once daily for 28 days. Each dose will be consumed with approximately eight ounces of water at the same time each day. If a dose is missed, participants will be instructed to take the missed dose the following day by splitting the dose into one capsule in the morning and one capsule in the evening.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Participants will ingest a placebo consisting of microcrystalline cellulose in capsule form once daily for 28 days. The placebo capsules will be identical in size, color, and appearance to the active supplement and will be consumed with approximately eight ounces of water at the same time each day. If a dose is missed, participants will be instructed to take the missed dose the following day by splitting the dose into one capsule in the morning and one capsule in the evening.",[15],[31],{"name":32,"affiliation":5,"role":33},"Chad M Kerksick, PhD","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Anthony M Hagele, MS","CONTACT","6369494785","ahagele@lindenwood.edu",{"name":41,"role":37,"phone":38,"phoneExt":26,"email":42},"Joesi M Krieger, MS","jmorey@lindenwood.edu",[44],{"facility":45,"status":26,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Exercise and Performance Nutrition Laboratory","Saint Charles","Missouri","63301","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-90.48123,38.78394,{"lat":55,"lon":54},[58,59,60],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":41,"role":37,"phone":38,"phoneExt":26,"email":42},{"name":32,"role":33,"phone":26,"phoneExt":26,"email":26},{"type":62,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100622774","evaluating-the-ability-of-a-multi-strain-postbiotic-to-impact-inflammation-immune-components-gastrointestinal-symptoms-recovery-anxiety-and-intestinal-permeability-100622774",false,"NCT07387991","Evaluating the Ability of a Multi-Strain Postbiotic to Impact Inflammation, Immune Components, Gastrointestinal Symptoms, Recovery, Anxiety, and Intestinal Permeability","Clinical Trial to Evaluate the Ability of Multi-Strain Postbiotic to Impact Inflammation, Immune Components, Gastrointestinal Symptoms, Recovery, Anxiety, and Intestinal Permeability","BIO","Inclusion Criteria:\n\nHealthy males and females aged 18 to 55 years of age. Individual indicates they are physically active defined as: 30 minutes of moderate intensity activity 4 days per week in the past 3 months.\n\nSubject has the ability to exercise on a treadmill without issue or concern. Body Mass Index (BMI) 18.0-32.0 kg\u002Fm2 (normal weight to obesity weight). The average BMI of the entire cohort will be \\\u003C30.0 kg\u002Fm2.\n\nSubject is in good health and appropriate for exercise as determined by physical examination and medical history.\n\nSubject can exercise on a treadmill without issue or concern. Subject is a non-smoker. Subject agrees to not use any new vitamin, mineral, or dietary supplements 24 hours prior to the exercise test visits.\n\nSubject is willing and able to comply with the protocol including: attending the study scheduled appointments, of which two of the study visits may take up to four hours of completion.\n\nSubject agrees to refrain from exercise for the 24 hours prior to any test visits.\n\nSubject agrees to refrain from alcohol use for at least 24 hours before every study visit.\n\nSubject is able to understand and sign the informed consent to participate in the study.\n\nExclusion Criteria:\n\nIndividuals who are determined to have liver, renal, cardiovascular, or other metabolic disease.\n\nUse of any dietary supplements, prescription mediation (particularly antibiotics and\u002For anti-inflammatories), or probiotics within the past 2 months which may confound the study or its endpoints.\n\nAlcohol consumption (\\>2 standard alcoholic drinks\u002Fday or \\>10 drinks\u002Fweek) or drug abuse\u002Fdependence.\n\nSmokers (defined as greater than 2 cigarettes per day for past 90 days). Clinically significant abnormal laboratory results at screening. Allergy or sensitivity to study supplement ingredients. Individuals who are cognitively impaired and\u002For who are unable to give informed consent.\n\nIndividuals with diabetes, asthma, rheumatoid arthritis, colitis, IBS\u002FIBD, gout, or fibromyalgia.\n\nAny other condition which in the PI's opinion may adversely affect the subject's ability to complete the study, its measurement or poses significant risk to the subject.",true,"ALL","18 Years","55 Years",{"count":76,"type":77},50,"ESTIMATED","INTERVENTIONAL",[80],"NA","This study will evaluate the effects of a multi-strain postbiotic supplement on markers of inflammation, immune function, gastrointestinal symptoms, psychological well-being, and intestinal permeability in healthy adults. The primary objective is to determine whether four weeks of postbiotic supplementation alters physiological and perceptual responses to a standardized bout of moderate-to-high intensity exercise compared with placebo.\n\nApproximately 50 healthy men and women aged 18 to 55 years will be enrolled in a randomized, double-blind, placebo-controlled, parallel-group clinical trial. Participants will be randomly assigned to receive either a multi-strain postbiotic supplement or a matched placebo for 28 days.\n\nAt the end of the supplementation period, participants will complete a 45-minute treadmill exercise bout at 75% of their individually determined maximum heart rate. Blood samples will be collected to assess biomarkers of inflammation, immune activity, and recovery. Gastrointestinal symptoms, intestinal permeability, anxiety, and perceived recovery will be evaluated using validated questionnaires.\n\nThis study is designed to determine whether postbiotic supplementation modulates physiological stress responses and subjective well-being following prolonged exercise in healthy adults.",[83,84],"Inflammation","Gastrointestinal Symptoms","NOT_YET_RECRUITING","2026-01-28",{"date":88,"type":89},"2026-02-04","ACTUAL",{"date":91,"type":77},"2026-06-01",{"date":93,"type":77},"2027-06-01",{"name":5,"class":6},1]