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Completed

NCT Number: NCT06903195

Effect of Chokeberry Supplementation on Oxidative Stress and Gut Integrity in Swimmers.

This study included 8 weeks of supplementation of black chokeberry extract with 18% standardization of the anthocyanins content (dose 2×200 mg per day) or a placebo product made from chokeberry fiber. The first research data was collected among twenty-four homogeneous female swimmers who trained intensively and attended the Sports Championship School Complex. The second research data was collected among a group of twenty-two selective and homogeneous female swimmers who attended the Sports Championship School Complex extensively.

In this study, the athletes were subjected to intensive swimming tests in breaststroke crawl (800m + 200m + 50m) with 15 minutes of active rest between test sections in the water.

Blood samples were taken from the cubital vein at three time points: before stress test (pre-exercise), one minute after the end of the test (post-exercise), and after a 3-hour recovery period (3h recovery). Measurements of morphology, 4-Hydroxynonenal (4-HNE), 8-isoprostane, cortysol, Intestinal fatty acid binding protein (I-FABP), claudin3, lipopolysaccharide (LPS), lipopolysaccharide binding protein (LBP), and levels were determined using ELISA kits (SunRed Biotechnology Company).

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Key information

Age range

12 year–16 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Poznań University of Physical Education

Poznan, 61-871, Poland

About this study

This study included 8 weeks of supplementation of black chokeberry extract with 18% standardization of the anthocyanins content (dose 2×200 mg per day), or a placebo product made from chokeberry fiber. The first date of research completed the group of twenty-four homogeneous female swimmers, who train swimming intensively and attend the Sports Championship School Complex. The second date of research completed the group of twenty-two selective and homogeneous female swimmers, who train swimming intensively and attend the Sports Championship School Complex.

In this study, the athletes were subjected to intensive swimming tests in breaststroke crawl (800m + 200m + 50m) with 15 minutes of active rest between test sections in the water. Blood samples were taken from the cubital vein at three time points: before stress test (pre-exercise), one minute after the end of the test (post-exercise), and after a 1-hour recovery period (3h recovery).

Measurement: All determined parameters were measured with the available equipment in the ZWKF laboratory in Gorzów Wielkopolski and using commercial assay kits. Measurements were performed by the project contractors.

  • Polyethylene tubes (2.7ml) containing dipotassium ethylenediaminetetraacetic acid (EDTA) anticoagulant were used for the following tests: (a) complete blood count (7 parameters) determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland). Red blood cell indices: RBC (Red Blood Cells), HGB (Hemoglobin), HCT (Hematocrit), MCV (Mean Corpuscular Volume), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), RDW (Red Blood Cell Distribution Width); (b) a manual blood smear was made by placing a drop of blood on a slide and then spreading it with a uniform motion. After drying, it was colored by the May Grunwald-Giemsa method according to the procedure. After drying, the stained and fixed smear was viewed under a microscope for quantitative and qualitative assessment.
  • Polyethylene clotting activator tubes (9 ml) were centrifuged to separate the morphotic elements from the serum using a centrifuge (3000 rpm for 10 min). The serum was pipetted into several Eppendorf tubes, which were then frozen (temp. -80 °C). All biochemical parameters were determined from the extracted serum: (a) using the ELISA method by the test manufacturer's instructions. The designations include the following parameters:

4-Hydroxynonenal (4-HNE), 8-isoprostane, cortysol, Intestinal fatty acid binding protein (I-FABP), claudin3, lipopolysaccharide (LPS), lipopolysaccharide binding protein (LBP).

(3) The lactate (La) concentration was determined from the capillary blood immediately after collection using a commercially available kit (Dr. Lange, Germany).

A nutritionist thoroughly analyzed the athletes' diets before each exercise test. Using a commercially available program, the amount of energy, protein, carbohydrates, fats, and fiber was then analyzed.

The experiment was conducted in accordance with the Declaration of Helsinki. The Ethical Committee of the Medical University of Poznan approved the study protocol.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • valid medical examination,
  • consent of the legal guardian of the underage athlete to participate in the study,
  • Training experience of a minimum of three years
  • Student of a sports championship school team,
  • completion of the exercise test in the swimming pool - crawl style intensive test (800 m + 200 m + 50 m) on two test deadlines

Exclusion criteria

  • antibiotic therapy,
  • supplementation, use of any drugs, or oral hormonal contraceptives
  • health problems within the last month

Treatment and study plan

Black chokeberry extract in capsules with 18% standardization of the anthocyanins content

Drug

Supplement group: supplement of diet - black chokeberry extract (capsules) with 18% standardization of the anthocyanins content (one capsule contained 200 mg). Each capsule also contained: chokeberry fiber, E460b magnesium salts of stearic acid (anti-caking agent), E551 silicon dioxide (anti-caking agent), hydrocypropyl methylcellulose (capsule shell) and E171 titanium dioxide (shell colour).

The producer of all capsules is MLD Biotrade in Poznan.

Chokeberry fiber in capsules

Drug

Placebo group: placebo product - chokeberry fiber (placebo capsules, which were made from chokeberry fiber).

The producer of all capsules is MLD Biotrade in Poznan.

Primary outcomes

  1. Changes from baseline in 4-Hydroxynonenal (4-HNE) level.

    Time frame: At rest (before the test), directly after the test, and after a 3-hour recovery period.

    Concentration of 4-Hydroxynonenal (4-HNE) [pg/ml]. ELISA method by the test manufacturer's instructions

  2. Changes from baseline in 8-isoprostane level.

    Time frame: At rest (before the test), directly after the test, and after a 3-hour recovery period.

    Concentration of 8-isoprostane [ng/mL]. ELISA method by the test manufacturer's instructions

  3. Changes from baseline in Cortysol level.

    Time frame: At rest (before the test), directly after the test, and after a 3-hour recovery period.

    Concentration of cortysol [ng/mL]. ELISA method by the test manufacturer's instructions

  4. complete blood count

    Time frame: At rest (before the test), directly after the test, and after a 3-hour recovery period.

    Red blood cell indices: RBC (Red Blood Cells) [106 × µL-1], HGB (Hemoglobin) [g/dL] , HCT (Hematocrit) [%], MCV (Mean Corpuscular Volume)[fl], MCH (Mean Corpuscular Hemoglobin) [pg], MCHC (Mean Corpuscular Hemoglobin Concentration) [g x dL-1] , RDW (Red Blood cells Distribution Width) [%] .

  5. a manual blood smear

    Time frame: At rest (before the test), directly after the test, and after a 3-hour recovery period.

    was made by placing a drop of blood on a slide and then spreading it with a uniform motion. After drying, it was colored by the May Grunwald-Giemsa method according to the procedure. The stained and fixed smear after drying was viewed under a microscope for quantitative and qualitative assessment.

  6. Changes from baseline in Intestinal fatty acid binfing protein (I_FABP) level.

    Time frame: At rest (before the test), directly after the test, and after a 3-hour recovery period.

    Concentration of I-FABP [pg/ml]. ELISA method by the test manufacturer's instructions

  7. Changes from baseline in Claudin3 level.

    Time frame: At rest (before the test), directly after the test, and after a 3-hour recovery period.

    Concentration of Claudin3 [ng/ml]. ELISA method by the test manufacturer's instructions

  8. Changes from baseline in lipopolisacharide (LPS) level.

    Time frame: At rest (before the test), directly after the test, and after a 3-hour recovery period.

    Concentration of LPS [EU/l]. ELISA method by the test manufacturer's instructions

  9. Changes from baseline in lipopolisacharide binding protein (LBP) level.

    Time frame: At rest (before the test), directly after the test, and after a 3-hour recovery period.

    Concentration of LBP [ug/ml]. ELISA method by the test manufacturer's instructions

Secondary outcomes

  1. Antropometric characteristic - height

    Time frame: Day 1 after overall fast

    Prior to the exercise test, the investigators measured the anthropometric parameters, including height (Seca 213 Hamburg, Deutschland) [cm]

  2. Antropometric characteristic - weight

    Time frame: Day 1 after overall fast

    Prior to the exercise test, the investigators measured the anthropometric parameters, including weight (Tanita BC 418 MA, Tanita Corporation, Tokyo, Japan) [kg]

  3. Food record - energy

    Time frame: Day before the Day 1, in the morning at Day 1

    Participants prepared a food record. The results were calculated using the dietetykpro program: energy [kcal]

  4. Food record - protein

    Time frame: Day before the Day 1, in the morning at Day 1

    Participants prepared a food record. The results were calculated using the dietetykpro program: protein [g]

  5. Food record - carobhydrates

    Time frame: Day before the Day 1, in the morning at Day 1

    Participants prepared a food record. The results were calculated using the dietetykpro program: carobhydrates [g]

  6. Food record - fiber

    Time frame: Day before the Day 1, in the morning at Day 1

    Participants prepared a food record. The results were calculated using the dietetykpro program: fiber [g]

  7. Food record - fat

    Time frame: Day before the Day 1, in the morning at Day 1

    Participants prepared a food record. The results were calculated using the dietetykpro program:: fat [g]

Sponsors and collaborators

Lead sponsor

Poznan University of Physical Education

Other

Registry information

Official study title

Effect of Chokeberry Supplementation on Oxidative Stress and Gut Microbiota in Swimmers.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 30, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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