Clinical trial NCT06903195: Effect of Chokeberry Supplementation on Oxidative Stress and Gut Integrity in Swimmers
Official title: Effect of Chokeberry Supplementation on Oxidative Stress and Gut Microbiota in Swimmers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stress Oxidative
Intestinal Permeability
Lead sponsor: Poznan University of Physical Education
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 22
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All competitors was randomly divided into two groups (double-blind): A. supplemented (n = 12), who received two times a day one capsules with highly concentrated 18% chokeberry extract (one capsule contained 200 mg).

B. control (n = 10) received placebo. The supplementation period was 8 weeks.
Primary purpose: BASIC_SCIENCE

Brief summary: This study included 8-weeks supplementation of black chokeberry extract with 18% standardization of the anthocyanins content (dose 2×200 mg per day), or a placebo product that was made from chokeberry fiber. The first date of research completed the group of twenty-four and 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 took 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 morphology, 4-Hydroxynonenal (4-HNE), 8-isoprostane, cortysol, Intestinal fatty acid binding protein (I-FABP), claudin3, lipopolisacharide (LPS), lipopolisacharide binding protein (LBP), levels were determined using ELISA kits (SunRed Biotechnology Company).

Detailed description: This study included 8-weeks supplementation of black chokeberry extract with 18% standardization of the anthocyanins content (dose 2×200 mg per day), or a placebo product that was made from chokeberry fiber. The first date of research completed the group of twenty-four and 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 took 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.

1. Polyethylene tubes (2.7ml) containing dipotassium ethylenediaminetetraacetic acid (EDTAK2) 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 cells 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. The stained and fixed smear after drying was viewed under a microscope for quantitative and qualitative assessment.
2. Polyethylene clotting activator tubes (9 ml) was centrifuged to separate the morphotic elements from the serum using a centrifuge (3000 rpm for 10 min). The serum was be pipetted into several Eppendorf tubes, which then were frozen (temp. -80 °C). All the following biochemical parameters was determined from the extracted serum: (a) using the ELISA method by the test manufacturer's instructions. The designations include the flowing parameters:

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

The athletes' diets were completely analyzed before each exercise test by a nutritionist. Participants, with the help of a dietician who was available during meals on test days, filled out food diaries. The amount of energy, protein, carbohydrates, fats and fiber were then analyzed using a commercially available program.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Changes from baseline in 4-Hydroxynonenal (4-HNE) level.
timeFrame: At rest (before the test), directly after the test, and after a 3-hour recovery period.
measure: Changes from baseline in 8-isoprostane level.
timeFrame: At rest (before the test), directly after the test, and after a 3-hour recovery period.
measure: Changes from baseline in Cortysol level.
timeFrame: At rest (before the test), directly after the test, and after a 3-hour recovery period.
measure: complete blood count
timeFrame: At rest (before the test), directly after the test, and after a 3-hour recovery period.
measure: a manual blood smear
timeFrame: At rest (before the test), directly after the test, and after a 3-hour recovery period.
measure: Changes from baseline in Intestinal fatty acid binfing protein (I_FABP) level.
timeFrame: At rest (before the test), directly after the test, and after a 3-hour recovery period.
measure: Changes from baseline in Claudin3 level.
timeFrame: At rest (before the test), directly after the test, and after a 3-hour recovery period.
measure: Changes from baseline in lipopolisacharide (LPS) level.
timeFrame: At rest (before the test), directly after the test, and after a 3-hour recovery period.
measure: Changes from baseline in lipopolisacharide binding protein (LBP) level.
timeFrame: At rest (before the test), directly after the test, and after a 3-hour recovery period.
Secondary outcomes:
measure: Antropometric characteristic - height
timeFrame: Day 1 after overall fast
measure: Antropometric characteristic - weight
timeFrame: Day 1 after overall fast
measure: Food record - energy
timeFrame: Day before the Day 1, in the morning at Day 1
measure: Food record - protein
timeFrame: Day before the Day 1, in the morning at Day 1
measure: Food record - carobhydrates
timeFrame: Day before the Day 1, in the morning at Day 1
measure: Food record - fiber
timeFrame: Day before the Day 1, in the morning at Day 1
measure: Food record - fat
timeFrame: Day before the Day 1, in the morning at Day 1
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznań University of Physical Education
Study officials:
References: