Stress OxidativePhase 4NCT06903195
Effect of Chokeberry Supplementation on Oxidative Stress and Gut Integrity in Swimmers.
A Phase 4 study testing Black chokeberry extract in capsules with 18% standardization of the anthocyanins content and Chokeberry fiber in capsules in people with Stress Oxidative and Intestinal Permeability, run by Poznan University of Physical Education at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 16 years, women only
- Conditions the study is for
- Stress Oxidative, Intestinal Permeability
- What is being tested?
- Black chokeberry extract in capsules with 18% standardization of the anthocyanins content and Chokeberry fiber in capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2023to 28 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- antibiotic therapy,
- supplementation, use of any drugs, or oral hormonal contraceptives
- health problems within the last month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Chokeberry Supplementation on Oxidative Stress and Gut Microbiota 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).
Read the 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.
- 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.
- Conditions
- Stress Oxidative, Intestinal Permeability
- Being tested
- Black chokeberry extract in capsules with 18% standardization of the anthocyanins content, Chokeberry fiber in capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black chokeberry extract in capsules with 18% standardization of the anthocyanins contentDrug
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 capsulesDrug
Placebo group: placebo product - chokeberry fiber (placebo capsules, which were made from chokeberry fiber).
The producer of all capsules is MLD Biotrade in Poznan.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Chokeberry fiber in capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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) [%] .
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At rest (before the test), directly after the test, and after a 3-hour recovery period.
Secondary outcomes (7)
Antropometric characteristic - height
Prior to the exercise test, the investigators measured the anthropometric parameters, including height (Seca 213 Hamburg, Deutschland) [cm]
Measured: Day 1 after overall fast
Antropometric characteristic - weight
Prior to the exercise test, the investigators measured the anthropometric parameters, including weight (Tanita BC 418 MA, Tanita Corporation, Tokyo, Japan) [kg]
Measured: Day 1 after overall fast
Food record - energy
Participants prepared a food record. The results were calculated using the dietetykpro program: energy [kcal]
Measured: Day before the Day 1, in the morning at Day 1
Food record - protein
Participants prepared a food record. The results were calculated using the dietetykpro program: protein [g]
Measured: Day before the Day 1, in the morning at Day 1
Food record - carobhydrates
Participants prepared a food record. The results were calculated using the dietetykpro program: carobhydrates [g]
Measured: Day before the Day 1, in the morning at Day 1
Food record - fiber
Participants prepared a food record. The results were calculated using the dietetykpro program: fiber [g]
Measured: Day before the Day 1, in the morning at Day 1
Food record - fat
Participants prepared a food record. The results were calculated using the dietetykpro program:: fat [g]
Measured: Day before the Day 1, in the morning at Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Mar 2023
- Primary completion28 Dec 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress OxidativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903195
- Sponsor's protocol ID
- SWIMMER- SUPL
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cichon-Wozniak J, Dziewiecka H, Ostapiuk-Karolczuk J, Mydlowska M, Szymanczuk M, Skarpanska-Stejnborn A. Exercise-induced oxidative and hematological responses in adolescent female swimmers during the luteal phase. Front Physiol. 2026 Apr 22;17:1705876. doi: 10.3389/fphys.2026.1705876. eCollection 2026.
PubMed 42099915
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chokeberry Supplementation on Oxidative Stress and Gut Microbiota in Swimmers.
- ClinicalTrials.gov ID
- NCT06903195
- Acronym / sponsor ID
- SWIMMER- SUPL
- Conditions
- Stress Oxidative, Intestinal Permeability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| supplemented | Experimental | Drug: Black chokeberry extract in capsules with 18% standardization of the anthocyanins contentThe 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. |
| Placebo | Placebo comparator | Drug: Chokeberry fiber in capsulesThe 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. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- antibiotic therapy,
- supplementation, use of any drugs, or oral hormonal contraceptives
- health problems within the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Black chokeberry extract in capsules with 18% standardization of the anthocyanins contentSupplement 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. | Drug | supplemented |
| Chokeberry fiber in capsulesPlacebo group: placebo product - chokeberry fiber (placebo capsules, which were made from chokeberry fiber). The producer of all capsules is MLD Biotrade in Poznan. | Drug | Placebo |
Primary outcome
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
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
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
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) [%] .
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.
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
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
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
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
7 secondary outcomes
Antropometric characteristic - height
Time frame: Day 1 after overall fast
Antropometric characteristic - weight
Time frame: Day 1 after overall fast
Food record - energy
Time frame: Day before the Day 1, in the morning at Day 1
Food record - protein
Time frame: Day before the Day 1, in the morning at Day 1
Food record - carobhydrates
Time frame: Day before the Day 1, in the morning at Day 1
Food record - fiber
Time frame: Day before the Day 1, in the morning at Day 1
Food record - fat
Time frame: Day before the Day 1, in the morning at Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Derived from this study: PubMed 42099915Cichon-Wozniak J, Dziewiecka H, Ostapiuk-Karolczuk J, Mydlowska M, Szymanczuk M, Skarpanska-Stejnborn A. Exercise-induced oxidative and hematological responses in adolescent female swimmers during the luteal phase. Front Physiol. 2026 Apr 22;17:1705876. doi: 10.3389/fphys.2026.1705876. eCollection 2026.
- Individual participant dataSharing planned: No
Related trials for Stress Oxidative
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
RecruitingObservational study
Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease
Gaucher Disease Type I, Oxidative Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Black chokeberry extract in capsules with 18% standardization of the anthocyanins content and Chokeberry fiber in capsules in people with Stress Oxidative and Intestinal Permeability, run by Poznan University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06903195, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.