[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"muscle-size\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:muscle-size":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"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":21,"type":22},54,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30],"Exercise","Anthocyanins","Muscle Size",[29,28,32,33,34],"Functional food","Muscle strength","Microbiota","NOT_YET_RECRUITING","2025-06-27",{"date":38,"type":39},"2025-07-08","ACTUAL",{"date":41,"type":22},"2025-11-01",{"date":43,"type":22},"2027-10-01",{"name":45,"class":46},"Burdur Mehmet Akif Ersoy University","OTHER"]