Effect of Supplementation With Anthocyanins on Iron Metabolism in Female Swimmers
NCT Number: NCT06486623
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Iron Deficiencies|Inflammation|Oxidative Stress|Female Athlete Triad
Interventions: DRUG: Black chokeberry extract in capsules with 18% standardization of the anthocyanins content|DRUG: Chokeberry fiber in capsules
Sponsor: Poznan University of Physical Education
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2023-03-01
Completion Date: 2023-12-28
Locations: University of Physical Education in Poznan, Poznań, Poland

Summary:
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.

Primary Outcome Measures: Physiological parameters of blood morphology I, erythrocytes: RBC \[10\^6/mL\], HGB \[g/dL\], HCT \[%\], MCV \[mm\^3\], MCH \[pg\], MCHC \[g/dL\], RDW \[%\],, 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 \[%\],, 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 \[%\], 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 \[µg/dl\], 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 \[ng/ml\], 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 \[mg/ml\], 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) \[µg/dl\], 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 \[ng/ml\], 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 \[ng/mL\], 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 \[mmol/l\], 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 \[ng/L\], 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 \[ng/L\], 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 \[ng/L\], 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 \[mg/dL\], 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 \[ng/ml\], At each exercise test (up to 15 minute before exercise)|Physiological parameter of hormonal indicator II, estradiol \[pg/ml\], At each exercise test (up to 15 minute before exercise)|Physiological parameter of hormonal indicator III, luteinizing hormone (LH) \[mIU/ml\], At each exercise test (up to 15 minute before exercise)|Physiological parameter of hormonal indicator IV, follicle-stimulating hormone (FSH) \[mIU/ml\], At each exercise test (up to 15 minute before exercise)|Other physiological parameter I, myoglobin \[ng/ml\], At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)|Other physiological parameter II, hypoxanthine \[mmol/l\], 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 \[mmol/l\], At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Secondary Outcome Measures: Physiological parameters of iron metabolism indicator VII, unsaturated iron-binding capacity (UIBC), Calculated with blood samples at each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)