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

Hanna Dziewiecka0 个研究点目标入组 40 人开始时间: 2026年10月5日最近更新: 2026年9月21日

适应症

干预措施

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 40
主要终点: Exercise-Induced Change in Circulating Lipopolysaccharide (LPS) Concentration

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: Double (Participant, Investigator)

盲法说明

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.

入排标准

年龄范围: 16 Years 至 35 Years（Child, Adult）
性别: Male
接受健康志愿者: 是

入选标准

•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.

排除标准

•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.

研究组 & 干预措施

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.

干预措施: Aronia melanocarpa Extract (Dietary Supplement)

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.

干预措施: Dietary Supplement: Placebo (Dietary Supplement)