Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06133751 |
| Other study ID # |
SKaczmarczyk_PhD |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2023 |
| Est. completion date |
June 10, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Poznan University of Physical Education |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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
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.
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.
