NCT Number: NCT07829523
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.
Trial opening soon.
Get Notified16 year–35 year
Male
Interventional
Not applicable
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 three capsules per day for 8 weeks. Each capsule contains 150 mg of dry Aronia melanocarpa extract standardized to 18% anthocyanins. Participants assigned to the placebo group will receive visually identical capsules containing Aronia fiber and technological excipients. Participants will be instructed to take one capsule with each main meal.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive three capsules daily for 8 weeks, with one capsule taken with each main meal. Each capsule contains 150 mg of dry Aronia melanocarpa extract standardized to 18% anthocyanins, Aronia fiber, magnesium salts of stearic acid (E460b), silicon dioxide (E551), and an HPMC capsule. The total daily dose of Aronia melanocarpa extract will be 450 mg.
Participants will receive three visually identical placebo capsules daily for 8 weeks, with one capsule taken with each main meal. The placebo capsules contain Aronia fiber and technological excipients but do not contain Aronia melanocarpa extract.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Baseline and Week 8.
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: The day before each exercise test, at baseline and after the 8-week intervention.
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: Baseline and Week 8.
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.
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.
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.
Height will be assessed before the exercise test at baseline and at Week 8. Height will be reported in percentage (cm).
Contact information is provided by the study sponsor or research team.
Hanna Dziewiecka
Other
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
Acronym: ARONIA-TLR
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