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

NCT ID: NCT06903195

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-12-28

Brief Summary

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).

Detailed Description

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.

1. 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.

2. 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.

Conditions

Stress Oxidative; Intestinal Permeability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

supplemented

The supplemented group (n=12) consumed capsules with highly concentrated 18% chokeberry extract (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.

The swimmers took 2 capsules a day (before breakfast and dinner) for nearly 56 days (depending on length menstrual cycle phase). The swimmers sipped each capsule with glass of water.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Placebo

The control group (n=10) consumed capsules that were made from chokeberry fiber. The producer of all capsules is MLD Biotrade in Poznan.

The swimmers took 2 capsules a day (before breakfast and dinner) for nearly 56 days (depending on length menstrual cycle phase). The swimmers sipped each capsule with glass of water.

Group Type: PLACEBO_COMPARATOR

Chokeberry fiber in capsules

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DRUG

Chokeberry fiber in capsules

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

The producer of all capsules is MLD Biotrade in Poznan.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Poznan University of Physical Education

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Poznań University of Physical Education

Poznan, , Poland

Countries

Poland

Other Identifiers

SWIMMER- SUPL

Identifier Type: -

Identifier Source: org_study_id