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

NCT07054671 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-07-08

No results posted yet for this 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.

Conditions

  • Exercise
  • Anthocyanins
  • Muscle Size

Interventions

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.

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.

Sponsors & Collaborators

  • Burdur Mehmet Akif Ersoy University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2027-03-01
Completion
2027-10-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07054671 on ClinicalTrials.gov