A Phase 1/2 interventional study of Black chokeberry extract in capsules with 18% standardization of the anthocyanins content and Chokeberry fiber in capsules in Iron Deficiencies, Inflammation and Oxidative Stress, sponsored by Poznan University of Physical Education. Completed at 1 site in Poland. Open to female participants aged 12 Years to 19 Years. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Poznan University of Physical Education · Phase 1/2, Interventional, and Basic science
The study included 8-weeks supplementation of black chokeberry extract with 18% standardization of the anthocyanins content (dose 2×200 mg per day), or a placebo product that was made from chokeberry fiber.
Purpose:
The aim of the study is effectiveness check of black chokeberry intake as a potential factor which, due to its ability to reduce inflammation and chelate iron ions, will have an impact on minimizing undesirable changes in the red blood cell system.
Hypothesis:
Main hypothesis: Supplementation of black chokeberry (Aronia melanocarpa) has a positive effect on iron economy of female swimmers.
Auxiliary hypotheses:
Study plan:
Before first term of the study:
Control of Menstrual Cycle Phases since March 2023 (installing the application on the phone - Menstrual Period Tracker calendar).
First term of the study:
Second term of the study:
Repeat the measurements from the 1st date of test.
Participants: The group of selective and homogeneous female swimmers, who train swimming intensively and attend the Sports Championship School Complex.
This study included 8-weeks supplementation of black chokeberry extract with 18% standardization of the anthocyanins content (dose 2×200 mg per day), or a placebo product that was made from chokeberry fiber. The first date of research completed the group of twenty-four and 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.
Purpose:
The aim of the study is effectiveness check of black chokeberry intake as a potential factor which, due to its ability to reduce inflammation and chelate iron ions, will have an impact on minimizing undesirable changes in the red blood cell system.
Hypothesis:
Main hypothesis: Supplementation of black chokeberry (Aronia melanocarpa) has a positive effect on iron economy of female swimmers.
Auxiliary hypotheses:
The research is going to be carried out as a medicinal experiment with tissue interference (approval of Research Ethics Committee: 538/22 of 06/23/2022, with changes: 221/23 of 03/09/2023). All swimmers qualified to study based on inclusion and exclusion criteria and were informed of the extract course of the study and gave written consent to participate.
EXPERIMENTAL PROCEDURE, WHICH WAS APPLIED (STUDY PLAN):
A. Before first term of the study:
Control of Menstrual Cycle Phases since March 2023 (installing the application on the phone - Menstrual Period Tracker calendar) and three surveys in three terms.
B. First term of the study:
Biochemical determinations - blood samples will be taken before and after exercise test as well as after 3-hour restitution, in order to determine:
value of indicators:
Blood samples were collected from the elbow vein into two 4-ml tubes (to obtain serum) and centrifuged at 3,000 rpn 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 -80 Celsius degrees until assays were performed. In addition, before and immediately after the exercise test, capillary blood was drawn from the earlobe to determine lactate levels.
Lactate level were determined immediately after capillary blood sampling using a commercial available kit (Dr Lange, Germany). The concentration of lactate was determined in mmol/l. Other measurements were determined using ELISA kits (DRG Medtek).
C. Second term of the study:
Biochemical determinations - blood samples will be taken before and after exercise test as well as after 3-hour restitution, in order to determine:
value of indicators responsible for:
Blood samples were collected from the elbow vein into two 4-ml tubes (to obtain serum) and centrifuged at 3,000 rpn and into 2,7-ml tubes to determine morphology. Morphology wa determined on the same day the samples were collected, while serum was frozen and stored at -80 Celsius degrees until assays were performed. In addition, before and immediately after the exercise test, capillary blood was drawn from the earlobe to determine lactate levels.
Lactate level were determined immediately after capillary blood sampling using a commercial available kit (Dr Lange, Germany). The concentration of lactate was determined in mmol/l. Other measurements were determined using ELISA kits (DRG Medtek).
Data collection, analysis in laboratory, statistical analysis and preparation articles to publication.
Exclusion Criteria:
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
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
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.
Also known as: Aronia melanocarpa
Placebo group: placebo product - chokeberry fiber (placebo capsules, which were made from chokeberry fiber). The producer of all capsules is MLD Biotrade in Poznan.
Also known as: Placebo product
Physiological parameters of blood morphology I
erythrocytes: RBC \[10\^6/mL\], HGB \[g/dL\], HCT \[%\], MCV \[mm\^3\], MCH \[pg\], MCHC \[g/dL\], RDW \[%\],
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Physiological parameters of blood morphology II
leukocytes: WBC \[10\^3/mL\], LYM \[10\^3/mL\], MON \[10\^3/mL\], GRA \[10\^3/mL\], LYM \[%\], MON \[%\], GRA \[%\],
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Physiological parameters of blood morphology III
thrombocytes: PLT \[10\^3/mL\], MPV \[mm\^3\], PCT \[%\], PDW \[%\]
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Physiological parameters of iron metabolism indicator I
iron \[µg/dl\]
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Physiological parameters of iron metabolism indicator II
hepcidin \[ng/ml\]
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Physiological parameters of iron metabolism indicator III
transferrin \[mg/ml\]
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Physiological parameters of iron metabolism indicator IV
total iron-binding capacity (TIBC) \[µg/dl\]
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Physiological parameters of iron metabolism indicator V
ferritin \[ng/ml\]
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Physiological parameters of iron metabolism indicator VI
erythroferrone \[ng/mL\]
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Physiological parameters of antioxidant-prooxidant indicator
total antioxidant capacity \[mmol/l\]
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Physiological parameters of immunological indicator I
interleukin 6 \[ng/L\]
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Physiological parameters of immunological indicator II
interleukin 2 \[ng/L\]
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Physiological parameters of immunological indicator III
interleukin 10 \[ng/L\]
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Physiological parameters of immunological indicator IV
C-reactive protein \[mg/dL\]
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Physiological parameter of hormonal indicator I
progesterone \[ng/ml\]
Time frame: At each exercise test (up to 15 minute before exercise)
Physiological parameter of hormonal indicator II
estradiol \[pg/ml\]
Time frame: At each exercise test (up to 15 minute before exercise)
Physiological parameter of hormonal indicator III
luteinizing hormone (LH) \[mIU/ml\]
Time frame: At each exercise test (up to 15 minute before exercise)
Physiological parameter of hormonal indicator IV
follicle-stimulating hormone (FSH) \[mIU/ml\]
Time frame: At each exercise test (up to 15 minute before exercise)
Other physiological parameter I
myoglobin \[ng/ml\]
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Other physiological parameter II
hypoxanthine \[mmol/l\]
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Other physiological parameter (with capillary blood - earlobe)
lactic acid \[mmol/l\]
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Physiological parameters of iron metabolism indicator VII
unsaturated iron-binding capacity (UIBC)
Time frame: Calculated with blood samples at each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Plan to share: No
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Poznan University of Physical Education