Effect of Aronia Supplementation on the LPS-CD14-TLR2/4 Axis in Football Players
ConditionExercise Training
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age16-35
SponsorHanna Dziewiecka
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Use of antibiotics, metformin, probiotics, prebiotics, or synbiotics within the 3 months preceding enrollment.
Vegan diet.
Regular gut-training practices.
Gastrointestinal infection.
Trial design
Design model
Parallel
Treatments tested in this trial
Aronia melanocarpa Extract
Dietary supplementParticipants 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: Placebo
Dietary supplementParticipants will receive one visually identical placebo capsule daily for 8 weeks.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Aronia melanocarpaExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).2
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).3
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).4
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).Secondary outcomes
1
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 8.2
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.3
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 8.4
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.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hanna Dziewiecka
Lead sponsor
Poznan University of Physical Education
Sponsor institution
Poznan University of Medical Sciences
Collaborator
Source ClinicalTrials.gov
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