Clinical trial
Effect of Supplementation With Anthocyanins Contained in Black Chokeberry (Aronia Melanocarpa) on Selected Indicators of Iron Metabolism in Female Swimmers
Name
MMydłowska_PhD
Description
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:
1. Supplementation of black chokeberry enhances the antioxidant status and has a positive effect on the prooxidant-antioxidant balance.
2. Supplementation of black chokeberry reduce inflammation induced by intensive exercises, by reducing inflammatory markers.
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:
1. Menstrual cycle control survey.
2. Conduct a body composition analysis.
3. Collection of blood samples before the exercise test for biochemical determinations.
4. Exercise test in the swimming pool - crawl style intensive test (800 m + 200 m + 50 m).
5. Collection of blood immediately after exercise and 3 hours later.
6. Supplementation for nearly 56 days, depending on the length of the menstrual cycle.
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.
Trial arms
Trial start
2023-03-01
Estimated PCD
2023-12-28
Trial end
2023-12-28
Status
Completed
Phase
Early phase I
Treatment
Black chokeberry extract in capsules with 18% standardization of the anthocyanins content
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.
Arms:
1. Supplemented group
Other names:
Aronia melanocarpa
Chokeberry fiber in capsules
Placebo group: placebo product - chokeberry fiber (placebo capsules, which were made from chokeberry fiber).
The producer of all capsules is MLD Biotrade in Poznan.
Arms:
2. Placebo group
Other names:
Placebo product
Size
22
Primary endpoint
Physiological parameters of blood morphology I
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
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
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
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
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
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
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
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
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
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
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
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
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
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
At each exercise test (up to 15 minute before exercise)
Physiological parameter of hormonal indicator II
At each exercise test (up to 15 minute before exercise)
Physiological parameter of hormonal indicator III
At each exercise test (up to 15 minute before exercise)
Physiological parameter of hormonal indicator IV
At each exercise test (up to 15 minute before exercise)
Other physiological parameter I
At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Other physiological parameter II
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)
At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Eligibility criteria
Inclusion Criteria:
* Current medical examinations issued by a sports medicine doctor
* Training experience a minimum of three years
* Student of a sports championship school team
* Consent of the athlete/legal guardian to participate in the research
* Completion of the exercise test in the swimming pool - crawl style intensive test (800 m + 200 m + 50 m) on two test deadline
Exclusion Criteria:
* Taking: oral contraceptive pills, supplements containing anthocyanin compounds during the study or a one month earlier
* Health problems
* Antibiotic therapy
Protocol
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Updated at
2024-07-03
1 organization
2 products
4 indications
Organization
Poznan University of Physical EducationProduct
Black chokeberry extractIndication
Iron DeficiencyIndication
InflammationIndication
Oxidative StressIndication
Female Athlete TriadProduct
Chokeberry fiber