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

NCT06903195 | Completed Phase 4 DMC

• 1 other identifier: SWIMMER- SUPL
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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).

Conditions

Stress Oxidative; Intestinal Permeability

Outcome Measures

Primary Outcomes (9)

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

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

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

• Changes from baseline in 8-isoprostane level.

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

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

• Changes from baseline in Cortysol level.

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

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

• complete blood count

  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) \[%\] .

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

• 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.

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

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

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

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

• Changes from baseline in Claudin3 level.

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

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

• Changes from baseline in lipopolisacharide (LPS) level.

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

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

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

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

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

Secondary Outcomes (7)

• Antropometric characteristic - height

  Day 1 after overall fast

• Antropometric characteristic - weight

  Day 1 after overall fast

• Food record - energy

  Day before the Day 1, in the morning at Day 1

• Food record - protein

  Day before the Day 1, in the morning at Day 1

• Food record - carobhydrates

  Day before the Day 1, in the morning at Day 1

Study Arms (2)

supplemented

EXPERIMENTAL

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.

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

Placebo

PLACEBO COMPARATOR

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.

Drug: Chokeberry fiber in capsules

Interventions

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.

supplemented

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.

Placebo

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Poznan University of Physical Education: lead

Study Sites (1)

Poznań University of Physical Education

Poznan, 61-871, Poland

Location

MeSH Terms

Interventions

Capsules

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: female swimmers
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All competitors were randomly divided into two groups (double-blind): A. supplemented (n = 12), who received two capsules with highly concentrated 18% chokeberry extract (one capsule contained 200 mg) twice a day. B. control (n = 10) received placebo. The supplementation period was 8 weeks.

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: March 1, 2023
• Primary Completion: December 28, 2023
• Study Completion: December 28, 2023
• Last Updated: July 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)