Iron DeficienciesPhase 1/2NCT06486623
Effect of Supplementation With Anthocyanins on Iron Metabolism in Female Swimmers
A Phase 1/2 study testing Black chokeberry extract in capsules with 18% standardization of the anthocyanins content and Chokeberry fiber in capsules in people with Iron Deficiencies and Inflammation, run by Poznan University of Physical Education at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 19 years, women only
- Conditions the study is for
- Iron Deficiencies, Inflammation, Oxidative Stress
- What is being tested?
- Black chokeberry extract in capsules with 18% standardization of the anthocyanins content and Chokeberry fiber in capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2023to 28 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Taking: oral contraceptive pills, supplements containing anthocyanin compounds during the study or a one month earlier
- Health problems
- Antibiotic therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Supplementation With Anthocyanins Contained in Black Chokeberry (Aronia Melanocarpa) on Selected Indicators of Iron Metabolism in Female Swimmers
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:
Read more
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:
- Supplementation of black chokeberry enhances the antioxidant status and has a positive effect on the prooxidant-antioxidant balance.
- 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:
- Menstrual cycle control survey.
- Conduct a body composition analysis.
- Collection of blood samples before the exercise test for biochemical determinations.
- Exercise test in the swimming pool - crawl style intensive test (800 m + 200 m + 50 m).
- Collection of blood immediately after exercise and 3 hours later.
- 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.
Read the detailed description
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:
- Supplementation of black chokeberry enhances the antioxidant status and has a positive effect on the prooxidant-antioxidant balance.
- Supplementation of black chokeberry reduce inflammation induced by intensive exercises, by reducing inflammatory markers.
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):
- 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.
- First term of the study:
- Menstrual cycle control by application Menstrual Tracker Period Calendar and surveys, before swimming test.
- Body composition analysis (TANITA MC-780 S MA).
- Biochemical determinations - blood samples will be taken before and after exercise test as well as after 3-hour restitution, in order to determine:
- morphological parameters,
- value of indicators:
- iron status problems (iron, hepcidin, erythroferrone, total iron-binding capacity, unsaturated iron-binding capacity, ferritin, transferrin,
- oxidative stress (total antioxidant capacity),
- immunological indicators (interleukins: IL-6, IL-2, IL-10, C-reactive protein),
- hormonal balance (progesterone, estradiol, luteinizing hormone, follicle-stimulating hormone),
- other: lactic acid, myoglobin, hypoxanthine. 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).
- Intensive exercise test in the swimming pool, before supplementation - crawl style (800 m + 200 m + 50 m) with 15-minute active rest between test sections.
- Supplementation of black chokeberry - nearly 56-days supplementation of black chokeberry extract with 18% standardization of the anthocyanins content (connection with menstrual cycle phase).The swimmers were randomly divided into two groups: supplementation and placebo. The placebo contained chokeberry fiber. Whole products were manufactured by MLB BIOTRADE, Poznan. The swimmers took 2 capsules per day (before breakfast and dinner) and they sipped each capsule with glass of water.
- Second term of the study:
- Menstrual cycle control by application Menstrual Tracker Period Calendar and surveys, before swimming test.
- Body composition analysis (TANITA MC-780 S MA).
- Biochemical determinations - blood samples will be taken before and after exercise test as well as after 3-hour restitution, in order to determine:
- morphological parameters (erythrocytes, leukocytes, thrombocytes),
- value of indicators responsible for:
- iron status problems (iron, hepcidin, erythroferrone, total iron-binding capacity, unsaturated iron-binding capacity, ferritin, transferrin),
- oxidative stress (total antioxidant capacity),
- immunological indicators (interleukins: IL-6, IL-2, IL-10, C-reactive protein (CRP)),
- hormonal balance (progesterone, estradiol, luteinizing hormone (LH), follicle-stimulating hormone (FSH)),
- other: lactic acid, myoglobin, hypoxanthine. 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).
- Intensive exercise test in the swimming pool, after supplementation - crawl style (800 m + 200 m + 50 m) with 15-minute active rest between test sections.
Data collection, analysis in laboratory, statistical analysis and preparation articles to publication.
- Being tested
- Black chokeberry extract in capsules with 18% standardization of the anthocyanins content, Chokeberry fiber in capsules
- Medical subject headings
- Iron Deficiencies, Inflammation, Female Athlete Triad Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black chokeberry extract in capsules with 18% standardization of the anthocyanins contentDrug
Also called Aronia melanocarpa
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.
Chokeberry fiber in capsulesDrug
Also called Placebo product
Placebo group: placebo product - chokeberry fiber (placebo capsules, which were made from chokeberry fiber).
The producer of all capsules is MLD Biotrade in Poznan.
| Study group | Role | What they receive |
|---|---|---|
| 1. Supplemented group | Experimental | 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. Receives: Drug: Black chokeberry extract in capsules with 18% standardization of the anthocyanins content |
| 2. Placebo group | Placebo comparator | 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. Receives: Drug: Chokeberry fiber in capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological parameters of blood morphology I
erythrocytes: RBC [10^6/mL], HGB [g/dL], HCT [%], MCV [mm^3], MCH [pg], MCHC [g/dL], RDW [%],
Measured: 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 [%],
Measured: 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 [%]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: At each exercise test (up to 15 minute before exercise)
Physiological parameter of hormonal indicator II
estradiol [pg/ml]
Measured: At each exercise test (up to 15 minute before exercise)
Physiological parameter of hormonal indicator III
luteinizing hormone (LH) [mIU/ml]
Measured: At each exercise test (up to 15 minute before exercise)
Physiological parameter of hormonal indicator IV
follicle-stimulating hormone (FSH) [mIU/ml]
Measured: At each exercise test (up to 15 minute before exercise)
Other physiological parameter I
myoglobin [ng/ml]
Measured: 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]
Measured: 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]
Measured: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Secondary outcomes (1)
Physiological parameters of iron metabolism indicator VII
unsaturated iron-binding capacity (UIBC)
Measured: Calculated with blood samples at each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Mar 2023
- Primary completion28 Dec 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficienciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Mydłowska, PhD student, Principal investigator, Poznań University of Physical Education, Faculty of sport sciences in Gorzów Wielkopolski
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486623
- Sponsor's protocol ID
- MMydłowska_PhD
- Status last verified
- Jan 2024
- First submitted
- 6 Feb 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supplementation With Anthocyanins Contained in Black Chokeberry (Aronia Melanocarpa) on Selected Indicators of Iron Metabolism in Female Swimmers
- ClinicalTrials.gov ID
- NCT06486623
- Acronym / sponsor ID
- MMydłowska_PhD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Supplementation of black chokeberry enhances the antioxidant status and has a positive effect on the prooxidant-antioxidant balance.
- 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:
- Menstrual cycle control survey.
- Conduct a body composition analysis.
- Collection of blood samples before the exercise test for biochemical determinations.
- Exercise test in the swimming pool - crawl style intensive test (800 m + 200 m + 50 m).
- Collection of blood immediately after exercise and 3 hours later.
- 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.
Detailed description
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:
- Supplementation of black chokeberry enhances the antioxidant status and has a positive effect on the prooxidant-antioxidant balance.
- Supplementation of black chokeberry reduce inflammation induced by intensive exercises, by reducing inflammatory markers.
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):
- 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.
- First term of the study:
- Menstrual cycle control by application Menstrual Tracker Period Calendar and surveys, before swimming test.
- Body composition analysis (TANITA MC-780 S MA).
- Biochemical determinations - blood samples will be taken before and after exercise test as well as after 3-hour restitution, in order to determine:
- morphological parameters,
- value of indicators:
- iron status problems (iron, hepcidin, erythroferrone, total iron-binding capacity, unsaturated iron-binding capacity, ferritin, transferrin,
- oxidative stress (total antioxidant capacity),
- immunological indicators (interleukins: IL-6, IL-2, IL-10, C-reactive protein),
- hormonal balance (progesterone, estradiol, luteinizing hormone, follicle-stimulating hormone),
- other: lactic acid, myoglobin, hypoxanthine. 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).
- Intensive exercise test in the swimming pool, before supplementation - crawl style (800 m + 200 m + 50 m) with 15-minute active rest between test sections.
- Supplementation of black chokeberry - nearly 56-days supplementation of black chokeberry extract with 18% standardization of the anthocyanins content (connection with menstrual cycle phase).The swimmers were randomly divided into two groups: supplementation and placebo. The placebo contained chokeberry fiber. Whole products were manufactured by MLB BIOTRADE, Poznan. The swimmers took 2 capsules per day (before breakfast and dinner) and they sipped each capsule with glass of water.
- Second term of the study:
- Menstrual cycle control by application Menstrual Tracker Period Calendar and surveys, before swimming test.
- Body composition analysis (TANITA MC-780 S MA).
- Biochemical determinations - blood samples will be taken before and after exercise test as well as after 3-hour restitution, in order to determine:
- morphological parameters (erythrocytes, leukocytes, thrombocytes),
- value of indicators responsible for:
- iron status problems (iron, hepcidin, erythroferrone, total iron-binding capacity, unsaturated iron-binding capacity, ferritin, transferrin),
- oxidative stress (total antioxidant capacity),
- immunological indicators (interleukins: IL-6, IL-2, IL-10, C-reactive protein (CRP)),
- hormonal balance (progesterone, estradiol, luteinizing hormone (LH), follicle-stimulating hormone (FSH)),
- other: lactic acid, myoglobin, hypoxanthine. 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).
- Intensive exercise test in the swimming pool, after supplementation - crawl style (800 m + 200 m + 50 m) with 15-minute active rest between test sections.
Data collection, analysis in laboratory, statistical analysis and preparation articles to publication.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Supplemented group | Experimental | Drug: Black chokeberry extract in capsules with 18% standardization of the anthocyanins contentThe 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. |
| 2. Placebo group | Placebo comparator | Drug: Chokeberry fiber in capsulesThe 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. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Taking: oral contraceptive pills, supplements containing anthocyanin compounds during the study or a one month earlier
- Health problems
- Antibiotic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Black chokeberry extract in capsules with 18% standardization of the anthocyanins contentAlso: Aronia melanocarpaSupplement 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. | Drug | 1. Supplemented group |
| Chokeberry fiber in capsulesAlso: Placebo productPlacebo group: placebo product - chokeberry fiber (placebo capsules, which were made from chokeberry fiber). The producer of all capsules is MLD Biotrade in Poznan. | Drug | 2. Placebo group |
Primary outcome
Physiological parameters of blood morphology I
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
erythrocytes: RBC [10^6/mL], HGB [g/dL], HCT [%], MCV [mm^3], MCH [pg], MCHC [g/dL], RDW [%],
Physiological parameters of blood morphology II
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
leukocytes: WBC [10^3/mL], LYM [10^3/mL], MON [10^3/mL], GRA [10^3/mL], LYM [%], MON [%], GRA [%],
Physiological parameters of blood morphology III
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
thrombocytes: PLT [10^3/mL], MPV [mm^3], PCT [%], PDW [%]
Physiological parameters of iron metabolism indicator I
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
iron [µg/dl]
Physiological parameters of iron metabolism indicator II
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
hepcidin [ng/ml]
Physiological parameters of iron metabolism indicator III
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
transferrin [mg/ml]
Physiological parameters of iron metabolism indicator IV
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
total iron-binding capacity (TIBC) [µg/dl]
Physiological parameters of iron metabolism indicator V
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
ferritin [ng/ml]
Physiological parameters of iron metabolism indicator VI
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
erythroferrone [ng/mL]
Physiological parameters of antioxidant-prooxidant indicator
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
total antioxidant capacity [mmol/l]
Physiological parameters of immunological indicator I
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
interleukin 6 [ng/L]
Physiological parameters of immunological indicator II
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
interleukin 2 [ng/L]
Physiological parameters of immunological indicator III
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
interleukin 10 [ng/L]
Physiological parameters of immunological indicator IV
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
C-reactive protein [mg/dL]
Physiological parameter of hormonal indicator I
Time frame: At each exercise test (up to 15 minute before exercise)
progesterone [ng/ml]
Physiological parameter of hormonal indicator II
Time frame: At each exercise test (up to 15 minute before exercise)
estradiol [pg/ml]
Physiological parameter of hormonal indicator III
Time frame: At each exercise test (up to 15 minute before exercise)
luteinizing hormone (LH) [mIU/ml]
Physiological parameter of hormonal indicator IV
Time frame: At each exercise test (up to 15 minute before exercise)
follicle-stimulating hormone (FSH) [mIU/ml]
Other physiological parameter I
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
myoglobin [ng/ml]
Other physiological parameter II
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
hypoxanthine [mmol/l]
Other physiological parameter (with capillary blood - earlobe)
Time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)
lactic acid [mmol/l]
1 secondary outcome
Physiological parameters of iron metabolism indicator VII
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Mydłowska, PhD student principal investigator
Poznań University of Physical Education, Faculty of sport sciences in Gorzów Wielkopolski
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Black chokeberry extract in capsules with 18% standardization of the anthocyanins content and Chokeberry fiber in capsules in people with Iron Deficiencies and Inflammation, run by Poznan University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological parameters of blood morphology I (time frame: At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.