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Inflammation;Muscle(S)Phase 4NCT06133751

Effect of 8-week Supplementation With Black Chokeberry on Recovery in Highly Trained Rowers

A Phase 4 study testing black chokeberry (Aronia melanocarpa) in people with Inflammation;Muscle(S) and Oxidative Stress Injury, run by Poznan University of Physical Education at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Purpose: To analyze the effects of 8-week supplementation with anthocyanin compounds contained in black chokeberry (Aronia melanocarpa) on indicators of inflammation and oxidative stress. Read more about this study

Who is it for?
Ages 18 to 24 years, men only
What is being tested?
black chokeberry (Aronia melanocarpa)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
1 sitePoland
Study dates
1 Apr 2023to 10 Jun 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 18 to 24 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Training experience a minimum of five years
  • Minimum training time per week 240 minute
  • Membership in the Youth National Rowing Team of Poland
  • Completion of the 2000m ergometer test on two test dates

Who cannot join

  • Taking other supplements containing anthocyanin compounds during the study period or a month earlier
  • Antibiotic therapy
  • Health problems

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • University of Physical Education in Poznan

    Poznan

Other trials in Poland

About this study

Official title: Effect of 8-week Supplementation With Anthocyanin Compounds Contained in Black Chokeberry on Inflammation and Oxidative Stress Induced by Very Intense Exercise in Highly Trained Rowers

Purpose: To analyze the effects of 8-week supplementation with anthocyanin compounds contained in black chokeberry (Aronia melanocarpa) on indicators of inflammation and oxidative stress.

Hypothesis: Supplementation with anti-inflammatory and antioxidant anthocyanin compounds improves recovery from intense exercise by reducing inflammation and oxidative stress in highly trained rowers

Read more

The study consisted of a nutritional intervention (supplementation) - with compounds of natural origin - chokeberry extract (capsules) - 18% standardized for anthocyanin content (dose 3 x 200 mg per day) - that is, 107 mg of pure anthocyanins per day, or a placebo product that was made from chokeberry fiber

Study plan I term of the study

  1. Conduct a body composition analysis, body height, food diary, self reported gastrointestinal scale
  2. Collection of blood samples before the exercise test for biochemical determinations.
  3. Exercise test of 2000m on a rowing ergometer.
  4. Collection of blood immediately after exercise and 1 hours after
  5. Collection of blood for biochemical determinations 24 hours after the end of the exercise test
  6. Supplementation for 8 weeks 2nd test date Repeat the measurements from the 1st test date.

Participants: Youth National Rowing Team of Poland Experimental procedure: Observation of the effect of black chokeberry consumption on parameters of inflammation, oxidative stress and intestinal parameters during the immediate start preparation period in highly skilled rowers.

Read the detailed description

Participants Twenty participants from the Youth National Rowing Team of Poland have been recruited for the study. In the end, fifteen rowers participated in the study (two did not show up for the first date, three more were absent for the second date). Before the first and second dates of the study, a body composition analysis was performed using the TANITA MC-780 with an accuracy of 0.05 kg, and hight was measured throughout sea 217 hightmeter. 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 (resolution no. 390/22). All players were informed of the exact course of the study and gave written consent to participate.

Youth National Rowing Team of Poland 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.

Experimental procedure The rowers were randomly divided into two groups-supplemented and control, it was a double-blind study. Athletes in the supplemented group (n=7) consumed capsules with highly concentrated 18% chokeberry extract. One capsule contained 200 mg. In addition to chokeberry extract, each capsule also contained chokeberry fiber, E460b magnesium salts of stearic acid (anti-caking agent), E551 silicon dioxide (anti-caking agent), hydroxypropyl methylcellulose (capsule shell) and E171 titanium dioxide (shell color). The control group (n=8) consumed capsules that were made from chokeberry fiber. All additional substances the same as in capsules with chokeberry extract. The supplement and placebo product was manufactured by MBL BIOTRADE, Poznań. The rowers (both supplemented and control group) took 3 capsules a day (at breakfast, lunch and dinner) for 8 weeks. The athletes sipped each capsule with a glass of water.

Exercise test On two testing dates (before and after supplementation), the athletes performed a 2,000-meter test on a rowing ergometer (Concept II, USA). Athletes had to complete the test in the shortest possible time overcoming the maximum load. The results of the test were taken into account in the selection for the championship team so the athletes performed the task with great motivation. Before the test, each competitor individually performed a 5-minute warm-up.

Material collection and examination Samples were taken at three time points: pre (before the exercise test) post (immediately after the exercise test and 1 hour after) and recovery (24 hours after the exercise test) both before and after the supplementation period. Blood samples were collected from the elbow vein into 9-ml tubes (to obtain serum) and centrifuged at 3,000 rpm and into 2.7-ml tubes (to determine morphology). Morphology was determined on the same day the samples were collected, while serum was frozen and stored at -80oC until assays were performed. In addition, before and immediately after the exercise test, capillary blood was drawn from the earlobe to determine lactate levels.

Measurements TAC (Total Antioxidant Capacity), TBARS (levels of lipid peroxidation products), IL-2, IL-6, IL-10, TNF-α and myoglobin levels were determined using ELISA kits (SunRed Biotechnology Company). Lactate levels were determined immediately after capillary blood sampling using a commercially available kit (Dr. Lange, Germany). The concentration of lactate was determined in mmol/l. intestinal parameters: LBP (lipopolysacharide-binding pro), Claudin3, I-FABP (intestinal fatty acid binding pro). After both tests, participants filled out self-reported gastrointestinal scale.

Any data obtained during the research will be used only for the purposes of this research project. The participant has the right to access and correct his/her data, to obtain information regarding the processing of his/her personal data, to request the deletion or restriction of the processing of his/her data, the right to portability of the data provided, the right to object to the processing, and the right to withdraw consent to the processing of personal data at any time. Withdrawal of consent does not affect the lawfulness of processing carried out on the basis of consent before its withdrawal.

The confidential nature of the research documentation will be respected throughout the study. Legal requirements for the protection of personal data will be observed. In the study documentation, participants will be identified by a nadem code at the beginning of the study. The results of this study will be published after pooled data analysis. Thus, the identity of the participants will remain confidential.

The place of data storage is the university's branch office in Gorzow Wielkopolski.

All parameters will be analyzed using Elisamtests and read on the ELISAMAR reader. In terms of statistical measures, the following will be performed: descriptive statistics, Shapiro-Wilk test to assess normality, and multivariate analysis of variance ANOVA test.

Being tested
black chokeberry (Aronia melanocarpa), Placebo
Medical subject headings
Myositis, Inclusion Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • black chokeberry (Aronia melanocarpa)Drug

    Black chokeberry capsules standardized for anthocyanin compounds

  • PlaceboDrug

    Chokeberry fiber placebo capsules

Study groups in NCT06133751
Study groupRoleWhat they receive
Supplemented groupExperimentalAthletes in the supplemented group (n=7) consumed capsules with highly concentrated 18% chokeberry extract. One capsule contained 200 mg. In addition to chokeberry extract, each capsule also contained chokeberry fiber, E460b magnesium salts of stearic acid (anti-caking agent), E551 silicon dioxide (anti-caking agent), hydroxypropyl methylcellulose (capsule shell) and E171 titanium dioxide (shell color). The rowers (both supplemented and control group) took 3 capsules a day (at breakfast, lunch and dinner) for 8 weeks. The athletes sipped each capsule with a glass of water.
Receives: Drug: black chokeberry (Aronia melanocarpa)
Placebo groupPlacebo comparatorThe control group (n=8) consumed capsules that were made from chokeberry fiber. The rowers (both supplemented and control group) took 3 capsules a day (at breakfast, lunch and dinner) for 8 weeks. The athletes sipped each capsule with a glass of water.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of total antioxidants (TAC)

    ELISA kits (SunRed Biotechnology Company) - Indicators of pro-oxidant-antioxidant balance

    Measured: 8 weeks

  2. interleukins: IL-2, IL-6, IL-10

    ELISA kits (SunRed Biotechnology Company) - Immunological indicators

    Measured: 8 weeks

  3. lactic acid

    Diaglobal, Berlin, Germany)

    Measured: 8 weeks

  4. LBP (lipopolysacharide-binding pro)

    ELISA kits (SunRed Biotechnology Company) - Gut parameter

    Measured: 8 weeks

  5. level of lipid peroxidation products (TBARS)

    ELISA kits (SunRed Biotechnology Company) - Indicators of pro-oxidant-antioxidant balance

    Measured: 8 weeks

  6. (NO) nitric oxide

    obtained by indirect method Griessa - Indicators of pro-oxidant-antioxidant balance

    Measured: 8 weeks

  7. comet assay (DNA damage)

    comet assay BioTechne

    Measured: 8 weeks

  8. tumor necrosis factor (TNF α)

    ELISA kits (SunRed Biotechnology Company) - Immunological indicators

    Measured: 8 weeks

  9. myoglobin

    ELISA kits (SunRed Biotechnology Company)

    Measured: 8 weeks

  10. I-FABP (intestinal fatty acid binding protein)

    ELISA kits (SunRed Biotechnology Company) - Gut parameter

    Measured: 8 weeks

  11. Claudin3

    ELISA kits (SunRed Biotechnology Company) - Gut parameter

    Measured: 8 weeks

Secondary outcomes (11)
  1. gastrointestinal symptom scale

    Self-reported 10-point scale, 10 is the most severe symptoms on the scale

    Measured: 8 weeks

  2. energy [kcal]

    dietitian program

    Measured: 8 weeks

  3. protein [g]

    dietitian program

    Measured: 8 weeks

  4. fat [g]

    dietitian program

    Measured: 8 weeks

  5. carbohydrate [g]

    dietitian program

    Measured: 8 weeks

  6. fiber [g]

    dietitian program

    Measured: 8 weeks

  7. body hight [m]

    secco 217 highmeter

    Measured: 8 weeks

  8. body mass [kg]

    body analyzer

    Measured: 8 weeks

  9. body fat [%,kg]

    body analyzer

    Measured: 8 weeks

  10. total body water [%,kg]

    body analyzer

    Measured: 8 weeks

  11. lean body mass [kg]

    body analyzer

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2023
  2. Study start1 Apr 2023
  3. Primary completion10 Jun 2023
  4. Study completion10 Jun 2023

Resources

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
Participants randomly divided into one of two groups. The supplemented group (n=7) receives chokeberry capsules, while the control group (n=8) receives a placebo product.
Masking
Single blind
Who is masked
Participant
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06133751
Sponsor's protocol ID
SKaczmarczyk_PhD
Status last verified
Oct 2023
First submitted
27 Oct 2023
Last updated
26 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kaczmarczyk S, Kasperska A, Dziewiecka H, Ostapiuk-Karolczuk J, Cichon-Wozniak J, Basta P, Skarpanska-Stejnborn A. A single 2000-meter exercise test to assess exercise adaptation in elite rowers during the preparatory phase. Front Physiol. 2025 Aug 12;16:1544637. doi: 10.3389/fphys.2025.1544637. eCollection 2025.

    PubMed 40873756

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing black chokeberry (Aronia melanocarpa) in people with Inflammation;Muscle(S) and Oxidative Stress Injury, 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 4 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 26 Apr 2024. 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?

Level of total antioxidants (TAC) (time frame: 8 weeks). The study lists 11 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 NCT06133751, 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 26 Apr 2024.

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