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

NCT07054671 | Not Yet Recruiting

• 1 other identifier: MAKU-AKDUMAN-3501-2025
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Anthocyanins; Exercise; Functional food; Muscle strength; Microbiota

Outcome Measures

Primary Outcomes (2)

• Change in Perceived Muscle Fatigue (VAS Score) After 12 Weeks

  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.

  Baseline and Week 12

• Change in Time-to-Exhaustion Performance After 12 Weeks

  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.

  Baseline and Week 12

Secondary Outcomes (3)

• Change in Gut Microbiota Composition

  Baseline and Week 12

• Change in Muscle Architecture Parameters

  Baseline and Week 12

• Change in Exercise Performance (VO₂peak)

  Baseline and Week 12

Study Arms (2)

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). Intervention; * Dietary Supplement (Elderberry-Based Functional Beverage) * A polyphenol and anthocyanin-rich beverage formulated from Sambucus nigra L., consumed once daily.

Dietary Supplement: Elderberry-Based Functional Beverage

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. Intervention: * Type: Placebo (Placebo Beverage) * A non-bioactive beverage matched for flavor and appearance, consumed once daily.

Dietary Supplement: Placebo Beverage

Interventions

Elderberry-Based Functional Beverage DIETARY_SUPPLEMENT

A polyphenol- and anthocyanin-rich beverage derived from Sambucus nigra L., administered once daily for 12 weeks as a dietary supplement.

Also known as: 1

Elderberry Beverage Group

Placebo Beverage DIETARY_SUPPLEMENT

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.

Placebo Beverage Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Burdur Mehmet Akif Ersoy University: lead

Study Sites (1)

MAKU Department of Nutrition and Dietetics

Burdur, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Gul Akduman, Dr.

CONTACT

+905380458382; gakduman@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Department of Nutrition and Dietetics

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 8, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-06

Locations

TU (1)