- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06133751
Effect of 8-week Supplementation With Black Chokeberry on Recovery in Highly Trained Rowers
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
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
- Conduct a body composition analysis, body height, food diary, self reported gastrointestinal scale
- Collection of blood samples before the exercise test for biochemical determinations.
- Exercise test of 2000m on a rowing ergometer.
- Collection of blood immediately after exercise and 1 hours after
- Collection of blood for biochemical determinations 24 hours after the end of the exercise test
- 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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Poznań, Poland
- University of Physical Education in Poznan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Taking other supplements containing anthocyanin compounds during the study period or a month earlier
- Antibiotic therapy
- Health problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supplemented group
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 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. |
Black chokeberry capsules standardized for anthocyanin compounds
|
|
Placebo Comparator: Placebo group
The 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. |
Chokeberry fiber placebo capsules
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of total antioxidants (TAC)
Time Frame: 8 weeks
|
ELISA kits (SunRed Biotechnology Company) - Indicators of pro-oxidant-antioxidant balance
|
8 weeks
|
|
interleukins: IL-2, IL-6, IL-10
Time Frame: 8 weeks
|
ELISA kits (SunRed Biotechnology Company) - Immunological indicators
|
8 weeks
|
|
lactic acid
Time Frame: 8 weeks
|
Diaglobal, Berlin, Germany)
|
8 weeks
|
|
LBP (lipopolysacharide-binding pro)
Time Frame: 8 weeks
|
ELISA kits (SunRed Biotechnology Company) - Gut parameter
|
8 weeks
|
|
level of lipid peroxidation products (TBARS)
Time Frame: 8 weeks
|
ELISA kits (SunRed Biotechnology Company) - Indicators of pro-oxidant-antioxidant balance
|
8 weeks
|
|
(NO) nitric oxide
Time Frame: 8 weeks
|
obtained by indirect method Griessa - Indicators of pro-oxidant-antioxidant balance
|
8 weeks
|
|
comet assay (DNA damage)
Time Frame: 8 weeks
|
comet assay BioTechne
|
8 weeks
|
|
tumor necrosis factor (TNF α)
Time Frame: 8 weeks
|
ELISA kits (SunRed Biotechnology Company) - Immunological indicators
|
8 weeks
|
|
myoglobin
Time Frame: 8 weeks
|
ELISA kits (SunRed Biotechnology Company)
|
8 weeks
|
|
I-FABP (intestinal fatty acid binding protein)
Time Frame: 8 weeks
|
ELISA kits (SunRed Biotechnology Company) - Gut parameter
|
8 weeks
|
|
Claudin3
Time Frame: 8 weeks
|
ELISA kits (SunRed Biotechnology Company) - Gut parameter
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
gastrointestinal symptom scale
Time Frame: 8 weeks
|
Self-reported 10-point scale, 10 is the most severe symptoms on the scale
|
8 weeks
|
|
energy [kcal]
Time Frame: 8 weeks
|
dietitian program
|
8 weeks
|
|
protein [g]
Time Frame: 8 weeks
|
dietitian program
|
8 weeks
|
|
fat [g]
Time Frame: 8 weeks
|
dietitian program
|
8 weeks
|
|
carbohydrate [g]
Time Frame: 8 weeks
|
dietitian program
|
8 weeks
|
|
fiber [g]
Time Frame: 8 weeks
|
dietitian program
|
8 weeks
|
|
body hight [m]
Time Frame: 8 weeks
|
secco 217 highmeter
|
8 weeks
|
|
body mass [kg]
Time Frame: 8 weeks
|
body analyzer
|
8 weeks
|
|
body fat [%,kg]
Time Frame: 8 weeks
|
body analyzer
|
8 weeks
|
|
total body water [%,kg]
Time Frame: 8 weeks
|
body analyzer
|
8 weeks
|
|
lean body mass [kg]
Time Frame: 8 weeks
|
body analyzer
|
8 weeks
|
Collaborators and Investigators
Investigators
- Study Director: Anna Skarpańska-Stejnborn, professor, Poznan University of Physical Education
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SKaczmarczyk_PhD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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