Effect of Aronia Supplementation on the LPS-CD14-TLR2/4 Axis in Football Players

NCT07829523 | Not Yet Recruiting

• 1 other identifier: ARONIA-TLR-2026-01
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Exercise Training

Keywords

Aronia melanocarpa; Anthocyanins; Exercise; Football; Lipopolysaccharide (LPS); Toll-Like Receptors; Monocytes; Innate Immunity

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  Baseline and Week 8.

• Dietary Intake Assessed Using a Food Diary

  The day before each exercise test, at baseline and after the 8-week intervention.

• Change in Body Fat Percentage

  Baseline and Week 8.

• Change in Fat-Free Mass

  Baseline and Week 8.

• Change in Total body water

  Baseline and Week 8.

Study Arms (2)

Aronia melanocarpa

EXPERIMENTAL

Participants will receive three capsules daily for 8 weeks. Each capsule contains 150 mg of dry Aronia melanocarpa extract standardized to 18% anthocyanins. One capsule will be taken with each main meal.

Dietary Supplement: Aronia melanocarpa Extract

Placebo

PLACEBO COMPARATOR

Participants will receive three visually identical placebo capsules daily for 8 weeks. The placebo capsules contain Aronia fiber and technological excipients. One capsule will be taken with each main meal.

Dietary Supplement: Dietary Supplement: Placebo

Interventions

Aronia melanocarpa Extract DIETARY_SUPPLEMENT

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.

Aronia melanocarpa

Dietary Supplement: Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanna Dziewiecka: lead
• Poznan University of Medical Sciences: collaborator

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Hanna Dziewiecka, PhD

CONTACT

606880282; hannadziewiecka@gmail.com

Marta Paek

CONTACT

dietetyka@awf-gorzow.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators will be blinded to group allocation. Participants will receive either Aronia melanocarpa supplementation or visually identical placebo capsules. Randomization and coding of the study products will be performed independently by the manufacturer. Group allocation will remain concealed until completion of data collection and analysis.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 21, 2026
• Study Start (Estimated): October 5, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share