Exercise TrainingARONIA-TLRNCT07829523
Effect of Aronia Supplementation on the LPS-CD14-TLR2/4 Axis in Football Players
A study testing Aronia melanocarpa Extract in people with Exercise Training, run by Hanna Dziewiecka.
Trial summary
This randomized, double-blind, placebo-controlled trial will investigate the effects of 8-week Aronia melanocarpa supplementation on exercise-induced activation of the LPS-LBP-CD14-TLR2/TLR4 axis in trained male football players. Read more about this study
- Who is it for?
- Ages 16 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Training
- What is being tested?
- Aronia melanocarpa Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2026to 30 Nov 2026
- 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 16 to 35 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male participants aged 16-35 years.
- Regularly training football players.
- Healthy and medically eligible to participate in the exercise testing.
- Willingness to comply with the study procedures and pre-test instructions.
Who cannot join
- Use of antibiotics, metformin, probiotics, prebiotics, or synbiotics within the 3 months preceding enrollment.
- Vegan diet.
- Regular gut-training practices.
- Gastrointestinal infection.
- Other significant diseases that, in the opinion of the study physician, may affect eligibility for participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Marta Paek contact
About this study
Official title: Effect of 8-Week Aronia Melanocarpa Supplementation on the Exercise-Induced LPS-LBP-CD14-TLR2/TLR4 Axis in Football Players: A Randomized, Double-Blind, Placebo-Controlled Trial
This randomized, double-blind, placebo-controlled trial will investigate the effects of 8-week Aronia melanocarpa supplementation on exercise-induced activation of the LPS-LBP-CD14-TLR2/TLR4 axis in trained male football players. Participants will be randomly assigned to receive either Aronia melanocarpa supplementation or placebo. Exercise testing will be performed before and after the 8-week intervention, with blood samples collected before, immediately after, and 1 hour after exercise. The study will assess circulating markers of endotoxemia and innate immune activation (LPS, LBP, sCD14, sTLR2, and sTLR4), TLR2 and TLR4 expression on monocyte subsets using flow cytometry, and TLR2 and TLR4 gene expression in peripheral blood mononuclear cells. The study aims to determine whether Aronia melanocarpa supplementation modulates the immune response to high-intensity intermittent exercise in football players.
Read the detailed description
High-intensity intermittent exercise, such as that performed during football, may induce gastrointestinal disturbances and transient alterations in intestinal barrier integrity. Exercise-related redistribution of blood flow away from the gastrointestinal tract, together with metabolic and thermal stress, may facilitate the translocation of bacterial products, including lipopolysaccharide (LPS), into the systemic circulation. LPS interacts with lipopolysaccharide-binding protein (LBP) and CD14 and may subsequently activate Toll-like receptors, particularly TLR4 and TLR2, contributing to the activation of innate immune responses.
Aronia melanocarpa is a rich source of polyphenolic compounds, particularly anthocyanins and proanthocyanidins, with antioxidant and anti-inflammatory properties. The present study will investigate whether 8 weeks of Aronia melanocarpa supplementation can modulate exercise-induced responses within the LPS-LBP-CD14-TLR2/TLR4 axis in trained male football players.
The study is designed as a randomized, double-blind, placebo-controlled trial. Thirty trained male football players aged 18-35 years will be recruited, allowing for an anticipated dropout rate, with a target sample size of 27 participants completing the study. Participants will be randomly assigned to an Aronia supplementation group or a placebo group. Randomization and coding of the capsules will be performed independently, and both participants and investigators will remain blinded to group allocation until completion of data collection and analysis.
Participants assigned to the intervention group will receive one capsule per day for 8 weeks. Each capsule contains 500 mg of dry Aronia melanocarpa extract standardized to 15% anthocyanins. Participants assigned to the placebo group will receive visually identical capsule.
Exercise testing will be conducted before the start of supplementation and after the 8-week intervention. Exercise capacity will be assessed using a maximal multistage 20-m shuttle run (Beep Test). Before each exercise session, participants will follow standardized pre-test procedures, including avoidance of alcohol and intense physical exercise for 48 hours, avoidance of caffeine for 24 hours, and adherence to a standardized low-FODMAP diet during the 24 hours preceding testing.
Venous blood samples will be collected before exercise, immediately after exercise, and 1 hour after exercise during both study sessions. The biological assessment will include circulating LPS, LBP, soluble CD14 (sCD14), soluble TLR2 (sTLR2), and soluble TLR4 (sTLR4). Flow cytometry will be used to characterize monocyte populations based on CD14 and CD16 expression and to assess TLR2 and TLR4 expression on these cells. In addition, TLR2 and TLR4 gene expression will be assessed in peripheral blood mononuclear cells using quantitative PCR.
By combining circulating biomarkers with cellular and gene-expression measurements, the study will provide a multilevel assessment of the LPS-LBP-CD14-TLR2/TLR4 pathway. The primary objective is to determine whether 8-week Aronia melanocarpa supplementation modifies the exercise-induced activation of this pathway in trained football players.
- Conditions
- Exercise Training
- Being tested
- Aronia melanocarpa Extract, Dietary Supplement: Placebo
- Keywords
- Aronia melanocarpa, Anthocyanins, Exercise, Football, Lipopolysaccharide (LPS), Toll-Like Receptors, Monocytes, Innate Immunity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aronia melanocarpa ExtractDietary supplement
Participants will receive one capsule daily for 8 weeks, in the morning. Each capsule contains 500 mg of dry Aronia melanocarpa extract standardized to 15% anthocyanins.
Dietary Supplement: PlaceboDietary supplement
Participants will receive one visually identical placebo capsule daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Aronia melanocarpa | Experimental | Participants will receive one capsules daily for 8 weeks. Each capsule contains 500 mg of dry Aronia melanocarpa extract standardized to 15% anthocyanins. One capsule will be taken in the morning. Receives: Dietary Supplement: Aronia melanocarpa Extract |
| Placebo | Placebo comparator | Participants will receive one visually identical placebo capsule daily for 8 weeks. Receives: Dietary Supplement: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise-Induced Change in Circulating Lipopolysaccharide (LPS) Concentration
Circulating lipopolysaccharide (LPS) concentration will be measured using an ELISA assay in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in circulating LPS and whether these responses differ between the Aronia and placebo groups.
Measured: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
Exercise-Induced Change in Circulating Lipopolysaccharide binding protein (LBP) Concentration
Circulating lipopolysaccharide binding protein (LBP) concentration will be measured using an ELISA assay in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in circulating LBP and whether these responses differ between the Aronia and placebo groups.
Measured: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
Exercise-Induced Change in Circulating Soluble CD14 (sCD14) Concentration
Circulating Soluble CD14 (sCD14) concentration will be measured using an ELISA assay in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in circulating sCD14 and whether these responses differ between the Aronia and placebo groups.
Measured: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
Exercise-Induced Change in Circulating Soluble Toll-Like Receptor 4 (sTLR4) Concentration
Circulating Soluble Toll-Like Receptor 4 (sTLR4) concentration will be measured using an ELISA assay in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in circulating sTLR4 and whether these responses differ between the Aronia and placebo groups.
Measured: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
Exercise-Induced Change in Circulating Soluble Toll-Like Receptor 2 (sTLR2) Concentration
Circulating Soluble Toll-Like Receptor 2 (sTLR2) concentration will be measured using an ELISA assay in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in circulating TLR2 and whether these responses differ between the Aronia and placebo groups.
Measured: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
Exercise-Induced Change in CD14+ Monocyte Population
The proportion of CD14+ monocytes will be assessed by flow cytometry in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in the CD14+ monocyte population and whether these responses differ between the Aronia and placebo groups.
Measured: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
Exercise-Induced Change in CD16+ Monocyte Population
The proportion of CD16+ monocytes will be assessed by flow cytometry in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in the CD16+ monocyte population and whether these responses differ between the Aronia and placebo groups.
Measured: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
Exercise-Induced Change in TLR2 Monocyte Population
The proportion of TLR2 monocytes will be assessed by flow cytometry in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in the CD14+ monocyte population and whether these responses differ between the Aronia and placebo groups.
Measured: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
Exercise-Induced Change in TLR4 Monocyte Population
The proportion of TLR4 monocytes will be assessed by flow cytometry in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in the CD14+ monocyte population and whether these responses differ between the Aronia and placebo groups.
Measured: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
Exercise-Induced Change in TLR2 Gene Expression in Peripheral Blood Mononuclear Cells
TLR2 gene expression will be assessed in peripheral blood mononuclear cells (PBMCs) isolated from blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. TLR2 gene expression will be quantified using real-time quantitative PCR and analyzed relative to the reference gene GUSB. The outcome will be used to assess exercise-induced changes in TLR2 gene expression and whether these responses differ between the Aronia and placebo groups.
Measured: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
Exercise-Induced Change in TLR4 Gene Expression in Peripheral Blood Mononuclear Cells
TLR4 gene expression will be assessed in peripheral blood mononuclear cells (PBMCs) isolated from blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. TLR4 gene expression will be quantified using real-time quantitative PCR and analyzed relative to the reference gene GUSB. The outcome will be used to assess exercise-induced changes in TLR4 gene expression and whether these responses differ between the Aronia and placebo groups.
Measured: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
Exercise-Induced Changes in Complete Blood Count Parameters
Complete blood count parameters, including hemoglobin, hematocrit, erythrocyte count, leukocyte count, granulocyte count, lymphocyte count, monocyte count, platelet count, MCV, MCH, MCHC, and RDW, will be assessed in venous blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo.
Measured: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
Secondary outcomes (6)
Change in Body Mass
Body mass will be measured before the exercise test at baseline and at Week 8. Body mass will be reported in kilograms (kg).
Measured: Baseline and Week 8.
Dietary Intake Assessed Using a Food Diary
Dietary intake will be assessed using a food diary completed on the day preceding each exercise test. Total energy intake and macronutrient intake, including protein, carbohydrate, and fat, will be calculated from the dietary records.
Measured: The day before each exercise test, at baseline and after the 8-week intervention.
Change in Body Fat Percentage
Body fat percentage will be assessed before the exercise test at baseline and at Week 8. Body fat will be reported as a percentage of total body mass (%).
Measured: Baseline and Week 8.
Change in Fat-Free Mass
Fat-free mass will be assessed before the exercise test at baseline and at Week 8. Fat-free mass will be reported in kilograms (kg).
Measured: Baseline and Week 8.
Change in Total body water
total body water will be assessed before the exercise test at baseline and at Week 8. Total body water will be reported in percentage (%).
Measured: Baseline and Week 8.
Change in height
Height will be assessed before the exercise test at baseline and at Week 8. Height will be reported in percentage (cm).
Measured: Baseline and Week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start10 Oct 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in parallel to one of two groups: an Aronia melanocarpa supplementation group or a placebo group. Participants will remain in their assigned group throughout the 8-week intervention. Exercise testing will be performed before and after the intervention.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanna Dziewiecka
- Sponsor type
- University, hospital or other
- Collaborators
- Poznan University of Medical Sciences
- Responsible party
- Sponsor-investigator, Hanna Dziewiecka, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829523
- Sponsor's protocol ID
- ARONIA-TLR-2026-01
- Acronym
- ARONIA-TLR
- Status last verified
- Oct 2026
- First submitted
- 7 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 8-Week Aronia Melanocarpa Supplementation on the Exercise-Induced LPS-LBP-CD14-TLR2/TLR4 Axis in Football Players: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07829523
- Acronym / sponsor ID
- ARONIA-TLR / ARONIA-TLR-2026-01
- Conditions
- Exercise Training
- Keywords
- Aronia melanocarpa, Anthocyanins, Exercise, Football, Lipopolysaccharide (LPS), Toll-Like Receptors, Monocytes, Innate Immunity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hanna DziewieckaUniversity, hospital or other
- Collaborators
- Poznan University of Medical Sciences
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, placebo-controlled trial will investigate the effects of 8-week Aronia melanocarpa supplementation on exercise-induced activation of the LPS-LBP-CD14-TLR2/TLR4 axis in trained male football players. Participants will be randomly assigned to receive either Aronia melanocarpa supplementation or placebo. Exercise testing will be performed before and after the 8-week intervention, with blood samples collected before, immediately after, and 1 hour after exercise. The study will assess circulating markers of endotoxemia and innate immune activation (LPS, LBP, sCD14, sTLR2, and sTLR4), TLR2 and TLR4 expression on monocyte subsets using flow cytometry, and TLR2 and TLR4 gene expression in peripheral blood mononuclear cells. The study aims to determine whether Aronia melanocarpa supplementation modulates the immune response to high-intensity intermittent exercise in football players.
Detailed description
High-intensity intermittent exercise, such as that performed during football, may induce gastrointestinal disturbances and transient alterations in intestinal barrier integrity. Exercise-related redistribution of blood flow away from the gastrointestinal tract, together with metabolic and thermal stress, may facilitate the translocation of bacterial products, including lipopolysaccharide (LPS), into the systemic circulation. LPS interacts with lipopolysaccharide-binding protein (LBP) and CD14 and may subsequently activate Toll-like receptors, particularly TLR4 and TLR2, contributing to the activation of innate immune responses.
Aronia melanocarpa is a rich source of polyphenolic compounds, particularly anthocyanins and proanthocyanidins, with antioxidant and anti-inflammatory properties. The present study will investigate whether 8 weeks of Aronia melanocarpa supplementation can modulate exercise-induced responses within the LPS-LBP-CD14-TLR2/TLR4 axis in trained male football players.
The study is designed as a randomized, double-blind, placebo-controlled trial. Thirty trained male football players aged 18-35 years will be recruited, allowing for an anticipated dropout rate, with a target sample size of 27 participants completing the study. Participants will be randomly assigned to an Aronia supplementation group or a placebo group. Randomization and coding of the capsules will be performed independently, and both participants and investigators will remain blinded to group allocation until completion of data collection and analysis.
Participants assigned to the intervention group will receive one capsule per day for 8 weeks. Each capsule contains 500 mg of dry Aronia melanocarpa extract standardized to 15% anthocyanins. Participants assigned to the placebo group will receive visually identical capsule.
Exercise testing will be conducted before the start of supplementation and after the 8-week intervention. Exercise capacity will be assessed using a maximal multistage 20-m shuttle run (Beep Test). Before each exercise session, participants will follow standardized pre-test procedures, including avoidance of alcohol and intense physical exercise for 48 hours, avoidance of caffeine for 24 hours, and adherence to a standardized low-FODMAP diet during the 24 hours preceding testing.
Venous blood samples will be collected before exercise, immediately after exercise, and 1 hour after exercise during both study sessions. The biological assessment will include circulating LPS, LBP, soluble CD14 (sCD14), soluble TLR2 (sTLR2), and soluble TLR4 (sTLR4). Flow cytometry will be used to characterize monocyte populations based on CD14 and CD16 expression and to assess TLR2 and TLR4 expression on these cells. In addition, TLR2 and TLR4 gene expression will be assessed in peripheral blood mononuclear cells using quantitative PCR.
By combining circulating biomarkers with cellular and gene-expression measurements, the study will provide a multilevel assessment of the LPS-LBP-CD14-TLR2/TLR4 pathway. The primary objective is to determine whether 8-week Aronia melanocarpa supplementation modifies the exercise-induced activation of this pathway in trained football players.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in parallel to one of two groups: an Aronia melanocarpa supplementation group or a placebo group. Participants will remain in their assigned group throughout the 8-week intervention. Exercise testing will be performed before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Aronia melanocarpa | Experimental | Dietary Supplement: Aronia melanocarpa ExtractParticipants will receive one capsules daily for 8 weeks. Each capsule contains 500 mg of dry Aronia melanocarpa extract standardized to 15% anthocyanins. One capsule will be taken in the morning. |
| Placebo | Placebo comparator | Dietary Supplement: Dietary Supplement: PlaceboParticipants will receive one visually identical placebo capsule daily for 8 weeks. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male participants aged 16-35 years.
- Regularly training football players.
- Healthy and medically eligible to participate in the exercise testing.
- Willingness to comply with the study procedures and pre-test instructions.
Key exclusion criteria (5 listed)
- Use of antibiotics, metformin, probiotics, prebiotics, or synbiotics within the 3 months preceding enrollment.
- Vegan diet.
- Regular gut-training practices.
- Gastrointestinal infection.
- Other significant diseases that, in the opinion of the study physician, may affect eligibility for participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aronia melanocarpa ExtractParticipants will receive one capsule daily for 8 weeks, in the morning. Each capsule contains 500 mg of dry Aronia melanocarpa extract standardized to 15% anthocyanins. | Dietary supplement | Aronia melanocarpa |
| Dietary Supplement: PlaceboParticipants will receive one visually identical placebo capsule daily for 8 weeks. | Dietary supplement | Placebo |
Primary outcome
Exercise-Induced Change in Circulating Lipopolysaccharide (LPS) Concentration
Time frame: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
Circulating lipopolysaccharide (LPS) concentration will be measured using an ELISA assay in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in circulating LPS and whether these responses differ between the Aronia and placebo groups.
Exercise-Induced Change in Circulating Lipopolysaccharide binding protein (LBP) Concentration
Time frame: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
Circulating lipopolysaccharide binding protein (LBP) concentration will be measured using an ELISA assay in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in circulating LBP and whether these responses differ between the Aronia and placebo groups.
Exercise-Induced Change in Circulating Soluble CD14 (sCD14) Concentration
Time frame: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
Circulating Soluble CD14 (sCD14) concentration will be measured using an ELISA assay in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in circulating sCD14 and whether these responses differ between the Aronia and placebo groups.
Exercise-Induced Change in Circulating Soluble Toll-Like Receptor 4 (sTLR4) Concentration
Time frame: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
Circulating Soluble Toll-Like Receptor 4 (sTLR4) concentration will be measured using an ELISA assay in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in circulating sTLR4 and whether these responses differ between the Aronia and placebo groups.
Exercise-Induced Change in Circulating Soluble Toll-Like Receptor 2 (sTLR2) Concentration
Time frame: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
Circulating Soluble Toll-Like Receptor 2 (sTLR2) concentration will be measured using an ELISA assay in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in circulating TLR2 and whether these responses differ between the Aronia and placebo groups.
Exercise-Induced Change in CD14+ Monocyte Population
Time frame: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
The proportion of CD14+ monocytes will be assessed by flow cytometry in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in the CD14+ monocyte population and whether these responses differ between the Aronia and placebo groups.
Exercise-Induced Change in CD16+ Monocyte Population
Time frame: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
The proportion of CD16+ monocytes will be assessed by flow cytometry in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in the CD16+ monocyte population and whether these responses differ between the Aronia and placebo groups.
Exercise-Induced Change in TLR2 Monocyte Population
Time frame: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
The proportion of TLR2 monocytes will be assessed by flow cytometry in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in the CD14+ monocyte population and whether these responses differ between the Aronia and placebo groups.
Exercise-Induced Change in TLR4 Monocyte Population
Time frame: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
The proportion of TLR4 monocytes will be assessed by flow cytometry in blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. The outcome will be used to assess exercise-induced changes in the CD14+ monocyte population and whether these responses differ between the Aronia and placebo groups.
Exercise-Induced Change in TLR2 Gene Expression in Peripheral Blood Mononuclear Cells
Time frame: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
TLR2 gene expression will be assessed in peripheral blood mononuclear cells (PBMCs) isolated from blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. TLR2 gene expression will be quantified using real-time quantitative PCR and analyzed relative to the reference gene GUSB. The outcome will be used to assess exercise-induced changes in TLR2 gene expression and whether these responses differ between the Aronia and placebo groups.
Exercise-Induced Change in TLR4 Gene Expression in Peripheral Blood Mononuclear Cells
Time frame: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
TLR4 gene expression will be assessed in peripheral blood mononuclear cells (PBMCs) isolated from blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo. TLR4 gene expression will be quantified using real-time quantitative PCR and analyzed relative to the reference gene GUSB. The outcome will be used to assess exercise-induced changes in TLR4 gene expression and whether these responses differ between the Aronia and placebo groups.
Exercise-Induced Changes in Complete Blood Count Parameters
Time frame: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).
Complete blood count parameters, including hemoglobin, hematocrit, erythrocyte count, leukocyte count, granulocyte count, lymphocyte count, monocyte count, platelet count, MCV, MCH, MCHC, and RDW, will be assessed in venous blood samples collected before exercise, immediately after exercise, and 1 hour after exercise. Measurements will be performed during two study sessions: before the intervention and after 8 weeks of Aronia melanocarpa supplementation or placebo.
6 secondary outcomes
Change in Body Mass
Time frame: Baseline and Week 8.
Dietary Intake Assessed Using a Food Diary
Time frame: The day before each exercise test, at baseline and after the 8-week intervention.
Change in Body Fat Percentage
Time frame: Baseline and Week 8.
Change in Fat-Free Mass
Time frame: Baseline and Week 8.
Change in Total body water
Time frame: Baseline and Week 8.
Change in height
Time frame: Baseline and Week 8.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marta Paek contact
Questions about this trial
What is this clinical trial studying?
A study testing Aronia melanocarpa Extract in people with Exercise Training, run by Hanna Dziewiecka.
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 4 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Hanna Dziewiecka, PhD (606880282 ext. +48, hannadziewiecka@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise-Induced Change in Circulating Lipopolysaccharide (LPS) Concentration (time frame: Baseline (before exercise, immediately after exercise, and 1 hour after exercise) and Week 8 (before exercise, immediately after exercise, and 1 hour after exercise).). The study lists 12 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 6 Oct 2026.