An interventional study of Aronia melanocarpa Extract and Dietary Supplement: Placebo in Exercise Training, sponsored by Hanna Dziewiecka. Not yet recruiting. Open to male participants aged 16 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Hanna Dziewiecka · Not applicable, Interventional, and Basic science
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.
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.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 8,388 interventional studies indexed under Motor Activity.
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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.
Dietary Supplement: Aronia melanocarpa Extract
Participants will receive one visually identical placebo capsule daily for 8 weeks.
Dietary Supplement: Dietary Supplement: Placebo
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.
Participants will receive one visually identical placebo capsule daily for 8 weeks.
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.
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).
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.
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).
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.
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).
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.
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).
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.
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).
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.
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).
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.
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).
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.
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).
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.
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).
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.
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).
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.
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).
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.
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).
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).
Time frame: 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.
Time frame: 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 (%).
Time frame: 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).
Time frame: 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 (%).
Time frame: 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).
Time frame: Baseline and Week 8.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Nov 2026, 1 month 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 1 month is below 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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