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Starting soon Not applicable

Effects of an Elderberry-Based Functional Beverage on Exercise Performance, Muscle Structure, and the Gut-Muscle Axis

NCT07054671 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-11-01
Last updated
2025-07-08

Condition(s) studied

ExerciseAnthocyaninsMuscle Size

Investigational drug(s) / intervention(s)

Elderberry-Based Functional BeveragePlacebo Beverage

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.

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.

Study summary

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.

Objective: 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.

Method: 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/week). 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.

Unique 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Engaging in regular physical activity at least 2 days per week * Body Mass Index (BMI) between 18.5 and 29.9 kg/m² * No use of antibiotics, probiotics, or prebiotics within the past 3 months * No history of chronic illness or autoimmune disorders * Physically able and eligible to participate in exercise training * Willingness to participate and provide written informed consent Exclusion Criteria: * Pregnancy or breastfeeding * Known food allergies * Regular use of medications such as corticosteroids, NSAIDs, or immunosuppressants * Professional-level athletes * 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.

Primary outcome measure(s)

  • Change in Perceived Muscle Fatigue (VAS Score) After 12 Weeks — Baseline and Week 12
    Muscle fatigue perception will be assessed using a 10-point visual analog scale (VAS), where 0 indicates no fatigue and 10 indicates extreme fatigue. Unit of Measure: Units on a 10-point scale Interpretation: A lower score indicates improvement.
  • Change in Time-to-Exhaustion Performance After 12 Weeks — Baseline and Week 12
    Muscle endurance will be assessed by measuring the time (in seconds) a participant can continue a standardized exercise until exhaustion. Unit of Measure: Seconds Interpretation: A higher time indicates improvement.

Trial sites (1)

FacilityCityRegionStatus
MAKU Department of Nutrition and Dietetics Burdur Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07054671 on ClinicalTrials.gov ↗ ← All trials in Turkey