[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597144":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":52,"collaborators":32,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":32,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":32,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":82,"whyStopped":32,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Burdur Mehmet Akif Ersoy University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Elderberry Beverage Group","EXPERIMENTAL","Participants will consume an anthocyanin-rich elderberry-based functional beverage daily for 12 weeks while following a combined exercise protocol (2 days resistance + 1 day endurance training per week).\n\nIntervention;\n\n* Dietary Supplement (Elderberry-Based Functional Beverage)\n* A polyphenol and anthocyanin-rich beverage formulated from Sambucus nigra L., consumed once daily.",[13],"Dietary Supplement: Elderberry-Based Functional Beverage",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Beverage Group","PLACEBO_COMPARATOR","Participants will consume a placebo beverage that is matched in color and taste but does not contain polyphenols or anthocyanins, while following the same combined exercise protocol.\n\nIntervention:\n\n* Type: Placebo (Placebo Beverage)\n* A non-bioactive beverage matched for flavor and appearance, consumed once daily.",[19],"Dietary Supplement: Placebo Beverage",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Elderberry-Based Functional Beverage","A polyphenol- and anthocyanin-rich beverage derived from Sambucus nigra L., administered once daily for 12 weeks as a dietary supplement.",[9],[27],"1",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo Beverage","A placebo beverage that mimics the elderberry drink in color and flavor but contains no polyphenols or bioactive compounds. Consumed once daily for 12 weeks.",[15],null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Gul Akduman, Dr.","CONTACT","+905380458382","gakduman@gmail.com",[40],{"facility":41,"status":32,"city":42,"state":32,"zip":32,"country":43,"countryCode":32,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"MAKU Department of Nutrition and Dietetics","Burdur","Turkey (Türkiye)",{"type":45,"coordinates":46},"Point",[47,48],30.29083,37.72028,{"lat":48,"lon":47},[51],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Gul Akduman","Research Assistant, Department of Nutrition and Dietetics","100597144","effects-of-an-elderberry-based-functional-beverage-on-exercise-performance-muscle-structure-and-the-gut-muscle-axis-100597144",false,"NCT07054671","Effects of an Elderberry-Based Functional Beverage on Exercise Performance, Muscle Structure, and the Gut-Muscle Axis","Investigating the Effects of Elderberry-Based Functional Beverage on Exercise Performance, Muscle Structure, and Gut-Muscle Axis: A Randomized Controlled Intervention Trial","Inclusion Criteria:\n\n* Engaging in regular physical activity at least 2 days per week\n* Body Mass Index (BMI) between 18.5 and 29.9 kg\u002Fm²\n* No use of antibiotics, probiotics, or prebiotics within the past 3 months\n* No history of chronic illness or autoimmune disorders\n* Physically able and eligible to participate in exercise training\n* Willingness to participate and provide written informed consent\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Known food allergies\n* Regular use of medications such as corticosteroids, NSAIDs, or immunosuppressants\n* Professional-level athletes\n* All participants will be instructed to avoid consuming any products containing berries (fresh, frozen, dried, jam, juice, or supplements) during the intervention period. A \"berry-free diet\" will be implemented as part of the study protocol. At baseline, a short Food Frequency Questionnaire (FFQ) will be administered to assess participants' berry consumption habits over the past month. The FFQ will include 10 commonly consumed berries in Türkiye: strawberry, raspberry, blackberry, blueberry, elderberry, mulberry, redcurrant, blackcurrant, aronia, and goji berry. Each item will be scored on a scale from 0 (never) to 4 (daily), and the total score will represent the individual's berry consumption score. Participants with a total baseline score of ≥10 will be excluded to minimize confounding from prior polyphenol exposure. The FFQ will only be used to assess baseline habits and ensure compliance with the berry-free protocol; it will not be used in primary outcome analyses.",true,"ALL","18 Years","45 Years",{"count":68,"type":69},54,"ESTIMATED","INTERVENTIONAL",[72],"NA","Introduction: Increasing sedentary lifestyle, microbiota imbalance and exercise-induced muscle fatigue are among the main causes of metabolic stress and performance decline, even in young individuals. The potential effects of functional foods-particularly polyphenol and anthocyanin-rich beverages-on both gut microbiota and muscle performance have attracted attention in recent years. In this context, intervention studies focused on the gut-muscle axis represent a promising and valuable area of research.\n\nObjective: This study aims to investigate the effects of a functional beverage enriched with anthocyanins and polyphenols -extracted from Sambucus nigra L. (black elderberry)- combined with a regular exercise program on muscle performance, muscle morphology, fatigue level, and gut microbiota composition in healthy individuals.\n\nMethod: This 12-week double-blind, randomized, placebo-controlled trial will include participants adhering to a berry-free diet. Participants will be randomly assigned to two groups: the intervention group will consume a functional elderberry beverage formulated with high-purity anthocyanins obtained via supercritical CO₂ extraction; the control group will receive a placebo beverage with matched taste and energy content but without active compounds. Both groups will engage in a structured combined exercise program (3 days\u002Fweek). Pre- and post-intervention assessments will include gut microbiota profiling (16S rRNA sequencing), short-chain fatty acid analysis, systemic biomarkers, muscle morphology (via ultrasound), exercise performance, and body composition. Mediator analyses will be used to explore the role of the gut-muscle axis in the observed effects.\n\nUnique value: This project represents one of the few human-based intervention studies systematically evaluating the interaction between functional beverages, exercise, and microbiota through the lens of muscle fiber-type-specific adaptations. Furthermore, by integrating mediator analyses and multi-level outcome measures, the study aims to elucidate the physiological relevance of the gut-muscle axis in a holistic manner. The development, standardization, and sensory evaluation of the elderberry-based beverage also contribute valuable insights to functional product innovation.",[75,76,77],"Exercise","Anthocyanins","Muscle Size",[76,75,79,80,81],"Functional food","Muscle strength","Microbiota","NOT_YET_RECRUITING","2025-06-27",{"date":85,"type":86},"2025-07-08","ACTUAL",{"date":88,"type":69},"2025-11-01",{"date":90,"type":69},"2027-10-01",{"name":5,"class":6},1]