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Not yet recruitingNCT07054671Updated Jul 8, 2025

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

An interventional study of Elderberry-Based Functional Beverage and Placebo Beverage in Exercise, Anthocyanins and Muscle Size, sponsored by Burdur Mehmet Akif Ersoy University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-08.

Sponsored by Burdur Mehmet Akif Ersoy University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 995 studies in Motor Activity with a site in Turkey — 196 open to participants now, 225 under way, none of them phase 3. Motor Activity · Turkey.

Planned enrollment
250th of 768
54 · median 42
Started
2025
with 147 others
No phase
768 of 995
160 open now
Primary completion
2027-03
later than 197 of 224 live
Registered
747th of 995
by date

Among the 995 studies in Motor Activity with a site in Turkey, this one is the 250th largest by planned enrollment of the 768 interventional ones, is one of 148 that started in 2025, is one of 768 with no phase, reaches primary completion later than 197 of the 224 other live ones, and was the 747th registered.

By phase

995 studies; the count open now beside each. This study's row is marked.

No phasethis study768 · 160 open
Observational227 · 36 open

By the year they started

First in 2002; this study’s year is marked. 148 started in 2025.

Size and results

Median enrollment 42 across the 768 interventional studies, 70 across the 227 observational. Of the 697 that completed or were terminated, 5 (1%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 995 studies in Motor Activity with a site in Turkey, or all of them as a file.
02

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.

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.

03

Conditions studied

  • Exercise
  • Anthocyanins
  • Muscle Size

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Keywords

  • Anthocyanins
  • Exercise
  • Functional food
  • Muscle strength
  • Microbiota
04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Engaging in regular physical activity at least 2 days per week
  • (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 disorders
  • Physically able and eligible to participate in exercise training
  • Willingness to participate and provide written

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Known food allergies
  • Regular use of medications such as , NSAIDs, or
  • 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (estimated)

Study arms

  • Experimental
    Elderberry Beverage Group

    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 comparator
    Placebo Beverage Group

    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

  • Dietary supplementElderberry-Based Functional Beverage

    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

  • Dietary supplementPlacebo 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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: Baseline and Week 12

Secondary outcomes

  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

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline and Week 12

07

Study locations

1 site
  • MAKU Department of Nutrition and Dietetics
    Burdur, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2025; primary completion for Mar 2027, 16 months later.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 16 months is close to that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 18, 2025
First posted
Jul 8, 2025
StartEst.
Nov 1, 2025
Primary completionEst.
Mar 1, 2027
CompletionEst.
Oct 1, 2027
Last update
Jul 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07054671
Lead sponsor
Burdur Mehmet Akif Ersoy University
Responsible party
Gul Akduman (Research Assistant, Department of Nutrition and Dietetics, Burdur Mehmet Akif Ersoy University) — Principal investigator
First posted
Jul 8, 2025
Start date
Nov 1, 2025 (estimated)
Primary completion
Mar 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Jul 8, 2025

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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