[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Beneo-Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":77},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100597425","the-effects-of-chicory-root-derived-prebiotic-on-mood-and-stress-responsiveness-in-healthy-adults-with-mild-to-moderate-levels-of-stress-and-anxiety-100597425",false,"NCT07058324","The Effects of Chicory Root-derived Prebiotic on Mood and Stress Responsiveness in Healthy Adults With Mild to Moderate Levels of Stress and Anxiety","The Effects of Chicory Root-derived Prebiotic on Mood and Stress Responsiveness in Healthy Adults With Mild to Moderate Levels of Stress and Anxiety: a Randomized, Placebo-controlled, Double-blind, Monocentric, Two-armed Parallel, Prospective Study - The PRIME Study","PRIME","Inclusion Criteria:\n\n1. Volunteer is healthy at the time of screening.\n2. TICS Screening Scale of Chronic Stress (SSCS) score ≥ 6.\n3. GAD total score ≥ 5 and ≤ 14 indicating mild to moderate anxiety.\n4. Male or female aged ≥18 and ≤ 70 years at the time of screening.\n5. Body-Mass-Index (BMI) ≥ 18.5 and ≤ 29.9 kg\u002Fm2.\n6. Volunteer is able and willing to comply with the study instructions.\n7. Volunteer is suitable for participation in the study according to the investigator\u002Fstudy personnel.\n8. Voluntary, written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. No command of local language.\n2. Previously or currently diagnosed neurological or psychiatric disorders.\n3. Previous history of renal, hepatic, cardiovascular disease or clinically significant diabetes.\n4. Gastrointestinal disorders including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or other conditions that might affect the gut environment.\n5. Contraindication or allergy to any substance in the verum or placebo product incl. lactose or fructose intolerance.\n6. Use of drugs (e.g., antibiotics, aspirin, proton pump inhibitors) influencing gastrointestinal function in the previous 8 weeks before the beginning of intervention.\n7. Use of laxatives and labelled pre-and probiotics in the previous 4 weeks before the beginning of intervention.\n8. Participation in another study with any investigational product within 30 days of screening or during the study.\n9. History of drug (recreational) or alcohol abuse.\n10. Use of anti-depressants medication including selective serotonin receptor inhibitors or amitriptyline for 3 months prior to screening.\n11. Bowel preparation for investigative procedures in the 4 weeks prior to screening.\n12. Surgical resection of any part of the bowel.\n13. Pregnant or lactating.\n14. Regular smoking.\n15. Previous Trier Social Stress Test (TSST) participation.",true,"ALL","18 Years","70 Years",{"count":22,"type":23},204,"ESTIMATED","INTERVENTIONAL",[26],"NA","Emerging evidence from preclinical research suggests that prebiotic fibres may play a beneficial role in supporting mental health through modulation of the gut-brain axis-a complex communication network linking the gastrointestinal tract and the central nervous system. Chicory root-derived prebiotic fibre, already well-established for its positive effects on glycaemic control and bowel regularity, has recently shown promise in this context. The present study aims to investigate the mental health benefits of chicory root fibre in a larger and more diverse population, thereby contributing to the growing body of evidence supporting nutritional strategies for mental well-being.",[29,30,31],"Stress","Healthy Subjects","Anxiety, Mild to Moderate",[33,34],"anxiety","prebiotics","RECRUITING","2025-08-04",{"date":38,"type":39},"2025-08-07","ACTUAL",{"date":41,"type":39},"2025-06-02",{"date":43,"type":23},"2026-08",{"name":45,"class":46},"Beneo-Institute","INDUSTRY",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":17,"sex":18,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":24,"phases":60,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":47},"100499429","prebiotic-effects-in-healthy-toddlers-100499429","NCT05783141","Prebiotic Effects in Healthy Toddlers","Double-blind, Randomized Placebo-controlled Trial Investigating Cumulative or Even Synergistic Effects of a Novel Prebiotic Combination in Healthy Toddlers","PrebiKidz","Inclusion Criteria:\n\n1. Child is healthy at the time of pre-examination\n2. Child is aged between 10-36 months and attends a day care center for the duration of the intervention\n3. Child attends a daycare center at the time of pre examination for at least 50%.\n4. Child presents a normal defecation characteristic (according to Brussels Infant and Toddler Stool scale)\n5. Weight for height z-score \\>-2 and \\\u003C2 SD based on Flemish growth charts\n6. Child and legal guardian are able and willing to follow the study instructions\n7. Child is suitable for participation in the study according to the investigator\u002F study personnel\n8. Informed written consent given by parent \u002F legal guardian\n\nExclusion Criteria:\n\n1. No legal guardian's command of any local language\n2. Child with any chronic disorder or disease, e.g., defecation disorders (incl. Hirschsprung and celiac disease) metabolic or renal abnormalities as well as mental or psychomotor retardation (incl. child´s mental delay and hypotonia)\n3. Child is suffering from congenital or acquired immunodeficiency\n4. Food allergies or intolerances\n5. Child is currently breast-fed more than once daily\n6. Use of drugs (e.g. antibiotics) influencing gastrointestinal function (6 weeks before intervention)\n7. Use of laxatives (4 weeks before intervention) as well as probiotic and prebiotic food supplements. Follow-on formula with L. Reuteri and\u002For GOS\u002FFOS\u002FHMO is allowed.\n8. Child is suffering from an infection at the time of pre examination or previous 7 days\n9. Child is currently involved or will be involved in another clinical or food study\n10. Child is not suitable for participation in the study according to the study personnel´s opinion","10 Months","36 Months",{"count":59,"type":23},342,[26],"The aim of this study is to demonstrate that a dietary supplementation with a novel prebiotic combination is safe, well tolerated and able to improve overall health of toddlers.",[63,64],"Child Development","Diet, Healthy",[66,67,68],"Microbiota","Prebiota","Child´s health","2024-09-05",{"date":71,"type":39},"2024-09-19",{"date":73,"type":39},"2023-10-01",{"date":75,"type":23},"2025-09",{"name":45,"class":46},""]