[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656774":3},{"organization":4,"outcomesModule":7,"designInfo":68,"detailedDescription":79,"studyPopulation":67,"armGroups":80,"interventions":93,"overallOfficials":67,"centralContacts":102,"locations":67,"responsibleParty":112,"collaborators":116,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":127,"sex":128,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":67,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":148,"whyStopped":67,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":67},{"fullName":5,"class":6},"Poznan University of Physical Education","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":46,"otherOutcomes":67},[9,13,16,19,22,25,28,31,34,37,40,43],{"measure":10,"description":11,"timeFrame":12},"Exercise-Induced Change in Circulating Lipopolysaccharide (LPS) Concentration","Circulating lipopolysaccharide (LPS) concentration will be measured using an ELISA assay in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in circulating LPS and whether these responses differ between the Aronia and placebo groups.","Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).",{"measure":14,"description":15,"timeFrame":12},"Exercise-Induced Change in Circulating Lipopolysaccharide binding protein (LBP) Concentration","Circulating lipopolysaccharide binding protein (LBP) concentration will be measured using an ELISA assay in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in circulating LBP and whether these responses differ between the Aronia and placebo groups.",{"measure":17,"description":18,"timeFrame":12},"Exercise-Induced Change in Circulating Soluble CD14 (sCD14) Concentration","Circulating Soluble CD14 (sCD14) concentration will be measured using an ELISA assay in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in circulating sCD14 and whether these responses differ between the Aronia and placebo groups.",{"measure":20,"description":21,"timeFrame":12},"Exercise-Induced Change in Circulating Soluble Toll-Like Receptor 4 (sTLR4) Concentration","Circulating Soluble Toll-Like Receptor 4 (sTLR4) concentration will be measured using an ELISA assay in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in circulating sTLR4 and whether these responses differ between the Aronia and placebo groups.",{"measure":23,"description":24,"timeFrame":12},"Exercise-Induced Change in Circulating Soluble Toll-Like Receptor 2 (sTLR2) Concentration","Circulating Soluble Toll-Like Receptor 2 (sTLR2) concentration will be measured using an ELISA assay in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in circulating TLR2 and whether these responses differ between the Aronia and placebo groups.",{"measure":26,"description":27,"timeFrame":12},"Exercise-Induced Change in CD14+ Monocyte Population","The proportion of CD14+ monocytes will be assessed by flow cytometry in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in the CD14+ monocyte population and whether these responses differ between the Aronia and placebo groups.",{"measure":29,"description":30,"timeFrame":12},"Exercise-Induced Change in CD16+ Monocyte Population","The proportion of CD16+ monocytes will be assessed by flow cytometry in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in the CD16+ monocyte population and whether these responses differ between the Aronia and placebo groups.",{"measure":32,"description":33,"timeFrame":12},"Exercise-Induced Change in TLR2 Monocyte Population","The proportion of TLR2 monocytes will be assessed by flow cytometry in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in the CD14+ monocyte population and whether these responses differ between the Aronia and placebo groups.",{"measure":35,"description":36,"timeFrame":12},"Exercise-Induced Change in TLR4 Monocyte Population","The proportion of TLR4 monocytes will be assessed by flow cytometry in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in the CD14+ monocyte population and whether these responses differ between the Aronia and placebo groups.",{"measure":38,"description":39,"timeFrame":12},"Exercise-Induced Change in TLR2 Gene Expression in Peripheral Blood Mononuclear Cells","TLR2 gene expression will be assessed in peripheral blood mononuclear cells (PBMCs) isolated from blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. TLR2 gene expression will be quantified using real-time quantitative PCR and analyzed relative to the reference gene GUSB. The outcome will be used to assess exercise-induced changes in TLR2 gene expression and whether these responses differ between the Aronia and placebo groups.",{"measure":41,"description":42,"timeFrame":12},"Exercise-Induced Change in TLR4 Gene Expression in Peripheral Blood Mononuclear Cells","TLR4 gene expression will be assessed in peripheral blood mononuclear cells (PBMCs) isolated from blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. TLR4 gene expression will be quantified using real-time quantitative PCR and analyzed relative to the reference gene GUSB. The outcome will be used to assess exercise-induced changes in TLR4 gene expression and whether these responses differ between the Aronia and placebo groups.",{"measure":44,"description":45,"timeFrame":12},"Exercise-Induced Changes in Complete Blood Count Parameters","Complete blood count parameters, including hemoglobin, hematocrit, erythrocyte count, leukocyte count, granulocyte count, lymphocyte count, monocyte count, platelet count, MCV, MCH, MCHC, and RDW, will be assessed in venous blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo.",[47,51,55,58,61,64],{"measure":48,"description":49,"timeFrame":50},"Change in Body Mass","Body mass will be measured before the exercise test at baseline and at Week 8. Body mass will be reported in kilograms (kg).","Baseline and Week 8.",{"measure":52,"description":53,"timeFrame":54},"Dietary Intake Assessed Using a Food Diary","Dietary intake will be assessed using a food diary completed on the day preceding each exercise test. Total energy intake and macronutrient intake, including protein, carbohydrate, and fat, will be calculated from the dietary records.","The day before each exercise test, at baseline and after the 8-week intervention.",{"measure":56,"description":57,"timeFrame":50},"Change in Body Fat Percentage","Body fat percentage will be assessed before the exercise test at baseline and at Week 8. Body fat will be reported as a percentage of total body mass (%).",{"measure":59,"description":60,"timeFrame":50},"Change in Fat-Free Mass","Fat-free mass will be assessed before the exercise test at baseline and at Week 8. Fat-free mass will be reported in kilograms (kg).",{"measure":62,"description":63,"timeFrame":50},"Change in Total body water","total body water will be assessed before the exercise test at baseline and at Week 8. Total body water will be reported in percentage (%).",{"measure":65,"description":66,"timeFrame":50},"Change in height","Height will be assessed before the exercise test at baseline and at Week 8. Height will be reported in percentage (cm).",null,{"allocation":69,"interventionModel":70,"interventionModelDescription":71,"primaryPurpose":72,"observationalModel":67,"timePerspective":67,"maskingInfo":73},"RANDOMIZED","PARALLEL","Participants will be randomly assigned in parallel to one of two groups: an Aronia melanocarpa supplementation group or a placebo group. Participants will remain in their assigned group throughout the 8-week intervention. Exercise testing will be performed before and after the intervention.","BASIC_SCIENCE",{"masking":74,"maskingDescription":75,"whoMasked":76},"DOUBLE","Participants and investigators will be blinded to group allocation. Participants will receive either Aronia melanocarpa supplementation or visually identical placebo capsules. Randomization and coding of the study products will be performed independently by the manufacturer. Group allocation will remain concealed until completion of data collection and analysis.",[77,78],"PARTICIPANT","INVESTIGATOR","High-intensity intermittent exercise, such as that performed during football, may induce gastrointestinal disturbances and transient alterations in intestinal barrier integrity. Exercise-related redistribution of blood flow away from the gastrointestinal tract, together with metabolic and thermal stress, may facilitate the translocation of bacterial products, including lipopolysaccharide (LPS), into the systemic circulation. LPS interacts with lipopolysaccharide-binding protein (LBP) and CD14 and may subsequently activate Toll-like receptors, particularly TLR4 and TLR2, contributing to the activation of innate immune responses.\n\nAronia melanocarpa is a rich source of polyphenolic compounds, particularly anthocyanins and proanthocyanidins, with antioxidant and anti-inflammatory properties. The present study will investigate whether 8 weeks of Aronia melanocarpa supplementation can modulate exercise-induced responses within the LPS-LBP-CD14-TLR2\u002FTLR4 axis in trained male football players.\n\nThe study is designed as a randomized, double-blind, placebo-controlled trial. Thirty trained male football players aged 18-35 years will be recruited, allowing for an anticipated dropout rate, with a target sample size of 27 participants completing the study. Participants will be randomly assigned to an Aronia supplementation group or a placebo group. Randomization and coding of the capsules will be performed independently, and both participants and investigators will remain blinded to group allocation until completion of data collection and analysis.\n\nParticipants assigned to the intervention group will receive one capsule per day for 8 weeks. Each capsule contains 500 mg of dry Aronia melanocarpa extract standardized to 15% anthocyanins. Participants assigned to the placebo group will receive visually identical capsule.\n\nExercise testing will be conducted before the start of supplementation and after the 8-week intervention. Exercise capacity will be assessed using a maximal multistage 20-m shuttle run (Beep Test). Before each exercise session, participants will follow standardized pre-test procedures, including avoidance of alcohol and intense physical exercise for 48 hours, avoidance of caffeine for 24 hours, and adherence to a standardized low-FODMAP diet during the 24 hours preceding testing.\n\nVenous blood samples will be collected before exercise, immediately after exercise, and 1 hour after exercise during both study sessions. The biological assessment will include circulating LPS, LBP, soluble CD14 (sCD14), soluble TLR2 (sTLR2), and soluble TLR4 (sTLR4). Flow cytometry will be used to characterize monocyte populations based on CD14 and CD16 expression and to assess TLR2 and TLR4 expression on these cells. In addition, TLR2 and TLR4 gene expression will be assessed in peripheral blood mononuclear cells using quantitative PCR.\n\nBy combining circulating biomarkers with cellular and gene-expression measurements, the study will provide a multilevel assessment of the LPS-LBP-CD14-TLR2\u002FTLR4 pathway. The primary objective is to determine whether 8-week Aronia melanocarpa supplementation modifies the exercise-induced activation of this pathway in trained football players.",[81,87],{"label":82,"type":83,"description":84,"interventionNames":85},"Aronia melanocarpa","EXPERIMENTAL","Participants will receive one capsules daily for 8 weeks. Each capsule contains 500 mg of dry Aronia melanocarpa extract standardized to 15% anthocyanins. One capsule will be taken in the morning.",[86],"Dietary Supplement: Aronia melanocarpa Extract",{"label":88,"type":89,"description":90,"interventionNames":91},"Placebo","PLACEBO_COMPARATOR","Participants will receive one visually identical placebo capsule daily for 8 weeks.",[92],"Dietary Supplement: Dietary Supplement: Placebo",[94,99],{"type":95,"name":96,"description":97,"armGroupLabels":98,"otherNames":67},"DIETARY_SUPPLEMENT","Aronia melanocarpa Extract","Participants will receive one capsule daily for 8 weeks, in the morning. Each capsule contains 500 mg of dry Aronia melanocarpa extract standardized to 15% anthocyanins.",[82],{"type":95,"name":100,"description":90,"armGroupLabels":101,"otherNames":67},"Dietary Supplement: Placebo",[88],[103,109],{"name":104,"role":105,"phone":106,"phoneExt":107,"email":108},"Hanna Dziewiecka, PhD","CONTACT","606880282","+48","hannadziewiecka@gmail.com",{"name":110,"role":105,"phone":67,"phoneExt":67,"email":111},"Marta Paek","dietetyka@awf-gorzow.edu.pl",{"type":113,"investigatorFullName":114,"investigatorTitle":115,"investigatorAffiliation":5,"oldNameTitle":67,"oldOrganization":67},"SPONSOR_INVESTIGATOR","Hanna Dziewiecka","Assistant Lecturer",[117],{"name":118,"class":6},"Poznan University of Medical Sciences","100656774","effect-of-aronia-supplementation-on-the-lps-cd14-tlr24-axis-in-football-players-100656774",false,"NCT07829523","Effect of Aronia Supplementation on the LPS-CD14-TLR2\u002F4 Axis in Football Players","Effect of 8-Week Aronia Melanocarpa Supplementation on the Exercise-Induced LPS-LBP-CD14-TLR2\u002FTLR4 Axis in Football Players: A Randomized, Double-Blind, Placebo-Controlled Trial","ARONIA-TLR","Inclusion Criteria:\n\n* Male participants aged 16-35 years.\n* Regularly training football players.\n* Healthy and medically eligible to participate in the exercise testing.\n* Willingness to comply with the study procedures and pre-test instructions.\n\nExclusion Criteria:\n\n* Use of antibiotics, metformin, probiotics, prebiotics, or synbiotics within the 3 months preceding enrollment.\n* Vegan diet.\n* Regular gut-training practices.\n* Gastrointestinal infection.\n* Other significant diseases that, in the opinion of the study physician, may affect eligibility for participation.",true,"MALE","16 Years","35 Years",{"count":132,"type":133},40,"ESTIMATED","INTERVENTIONAL",[136],"NA","This randomized, double-blind, placebo-controlled trial will investigate the effects of 8-week Aronia melanocarpa supplementation on exercise-induced activation of the LPS-LBP-CD14-TLR2\u002FTLR4 axis in trained male football players. Participants will be randomly assigned to receive either Aronia melanocarpa supplementation or placebo. Exercise testing will be performed before and after the 8-week intervention, with blood samples collected before, immediately after, and 1 hour after exercise. The study will assess circulating markers of endotoxemia and innate immune activation (LPS, LBP, sCD14, sTLR2, and sTLR4), TLR2 and TLR4 expression on monocyte subsets using flow cytometry, and TLR2 and TLR4 gene expression in peripheral blood mononuclear cells. The study aims to determine whether Aronia melanocarpa supplementation modulates the immune response to high-intensity intermittent exercise in football players.",[139],"Exercise Training",[82,141,142,143,144,145,146,147],"Anthocyanins","Exercise","Football","Lipopolysaccharide (LPS)","Toll-Like Receptors","Monocytes","Innate Immunity","NOT_YET_RECRUITING","2026-10-01",{"date":151,"type":152},"2026-10-06","ACTUAL",{"date":154,"type":133},"2026-10-10",{"date":156,"type":133},"2026-11-30",{"name":114,"class":6}]