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ExerciseNCT07054671

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

A study testing Elderberry-Based Functional Beverage in people with Exercise and Anthocyanins, run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Exercise, Anthocyanins, Muscle Size
What is being tested?
Elderberry-Based Functional Beverage
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2025to 1 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gul Akduman, Dr. contact

+905380458382

gakduman@gmail.com

Turkey (Türkiye)1 site
  • MAKU Department of Nutrition and Dietetics

    Burdur

    Gul Akduman, Dr., +905380458382, gakduman@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: Investigating the Effects of Elderberry-Based Functional Beverage on Exercise Performance, Muscle Structure, and Gut-Muscle Axis: A Randomized Controlled Intervention Trial

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.

Read more

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.

Read the detailed description

In modern times, the increasing prevalence of sedentary lifestyles, age-related decline in muscle function, and gut dysbiosis have been shown to negatively affect both metabolic health and muscular performance. These problems are not only observed in the elderly population but also in physically active young individuals, manifesting as exercise-induced fatigue, reduced performance, and impaired immune function. Sustaining muscle performance is closely related not only to physical fitness but also to maintaining gut microbiota balance and controlling inflammation.

The health effects of functional foods have become a focal point in multidisciplinary research in recent years. In this context, developing functional beverages rich in bioactive compounds such as polyphenols, flavonoids, and anthocyanins offers new research opportunities, particularly in the fields of exercise physiology and immune response. This study aims to evaluate the effects of an anthocyanin-enriched functional beverage derived from Sambucus nigra L. (elderberry) on muscle performance, fatigue, and the gut-muscle axis in healthy individuals participating in a combined exercise protocol.

Elderberry is a bioactive source noted for its high anthocyanin content, showing antioxidant and anti-inflammatory effects, and its potential to positively modulate gut microbiota. Since anthocyanins are only minimally absorbed in the small intestine, a large proportion reaches the colon, where they are fermented by the gut microbiota into various phenolic acids. This fermentation process may support the proliferation of beneficial species such as Bifidobacterium and Lactobacillus, while reducing pathogenic species such as Clostridium perfringens. Furthermore, elderberry polyphenols may promote the growth of anti-inflammatory species like Akkermansia muciniphila and Faecalibacterium prausnitzii. These microbial changes-especially the increase in short-chain fatty acids (SCFAs), particularly butyrate-have been associated with improved immune response, gut barrier integrity, and muscle metabolism. In vivo studies have shown that anthocyanin supplementation enhances microbial diversity and stimulates SCFA production, thereby helping to suppress inflammation. Within the so-called "gut-muscle axis," SCFAs-especially butyrate-play roles in muscle protein synthesis, mitochondrial function, and inflammation regulation. Some animal studies have also shown that modulation of microbiota composition via probiotics and polyphenol supplementation positively affects muscle mass and endurance.

Therefore, the researchers hypothesize that the elderberry-based beverage may reduce exercise-induced muscle fatigue and enhance performance not only through systemic antioxidant mechanisms but also by regulating gut microbiota. Consequently, this study will also assess how the microbiota changes induced by the beverage affect muscle metabolism.

A combined exercise protocol (2 days of resistance + 1 day of endurance) has been chosen, as it is an effective model for stimulating both cardiorespiratory capacity and muscle function. The literature highlights that endurance training improves mitochondrial biogenesis, oxidative capacity, and lactate clearance, whereas resistance training increases muscular strength and hypertrophy. It has been demonstrated that combined protocols are more effective for improving metabolic health and functional capacity.

To evaluate not only general muscle hypertrophy but also fiber-type-specific physiological adaptations, three muscle groups will be assessed: quadriceps, soleus (Type I fiber dominant), and gastrocnemius (Type II fiber dominant). These muscles were selected based on their well-defined morphological and metabolic profiles in the literature, allowing for indirect assessment of anthocyanins and polyphenols on mitochondrial function and oxidative stress. This makes the study one of the few human-based interventions that systematically investigates the effects of functional foods on exercise physiology with a muscle fiber-type-specific approach.

This study is among the few examples in the literature that evaluate functional beverages not only at the bioactive compound level but also in the context of exercise physiology and microbiota interaction. Most current research focuses on the short-term effects of polyphenol supplementation or isolated microbiota outcomes. However, this project aims to evaluate the holistic effects of a polyphenol/anthocyanin-rich functional beverage on both performance physiology and gut microbiota. Furthermore, the mediating role of the gut-muscle axis will be explored through quantitative measurements. This approach introduces a new methodological framework for both bioactive food development and microbiota-based exercise science. To date, there has been no human-based randomized controlled trial combining exercise, microbiota, and functional beverage interventions in the same design.

Being tested
Elderberry-Based Functional Beverage, Placebo Beverage
Keywords
Anthocyanins, Exercise, Functional food, Muscle strength, Microbiota
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Elderberry-Based Functional BeverageDietary supplement

    Also called 1

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

  • Placebo BeverageDietary 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.

Study groups in NCT07054671
Study groupRoleWhat they receive
Elderberry Beverage GroupExperimentalParticipants 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.
Receives: Dietary Supplement: Elderberry-Based Functional Beverage
Placebo Beverage GroupPlacebo comparatorParticipants 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.
Receives: Dietary Supplement: Placebo Beverage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Week 12

  2. 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.

    Measured: Baseline and Week 12

Secondary outcomes (3)
  1. Change in Gut Microbiota Composition

    Fecal samples will be collected to evaluate taxonomic and functional changes in gut microbiota using 16S rRNA sequencing. Relative abundance of key microbial taxa (e.g., Akkermansia muciniphila, Faecalibacterium prausnitzii) and alpha diversity indexes will be reported.

    Unit of Measure: Alpha diversity index units (e.g., Shannon index); relative abundance (%) Interpretation: Increased diversity or beneficial taxa indicate improvement

    Measured: Baseline and Week 12

  2. Change in Muscle Architecture Parameters

    Muscle architecture will be assessed via ultrasound by measuring muscle thickness (mm) and pennation angle (degrees) separately for each muscle. Each parameter will be reported individually.

    Unit of Measure: millimeters (mm) and degrees (°) Interpretation: Increases in muscle thickness and pennation angle reflect hypertrophic adaptations.

    Measured: Baseline and Week 12

  3. Change in Exercise Performance (VO₂peak)

    Maximal oxygen consumption (VO₂peak) will be measured using a graded treadmill test following standard protocols. Improved values will reflect enhanced aerobic capacity.

    Unit of Measure: mL/kg/min Interpretation: Higher VO₂peak indicates improved aerobic performance.

    Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2025
  2. Study start1 Nov 2025 (estimated)
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07054671
Sponsor's protocol ID
MAKU-AKDUMAN-3501-2025
Status last verified
Jun 2025
First submitted
18 Jun 2025
Last updated
8 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The decision to share individual participant data (IPD) will depend on the ethical committee's final approval and data protection considerations. If permitted, de-identified data may be shared with qualified researchers upon reasonable request following publication. Until ethical clearance for data sharing is obtained, no commitment can be made.

Questions about this trial

What is this clinical trial studying?

A study testing Elderberry-Based Functional Beverage in people with Exercise and Anthocyanins, run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gul Akduman, Dr. (+905380458382, gakduman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Perceived Muscle Fatigue (VAS Score) After 12 Weeks (time frame: Baseline and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

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