Ignite Creation Date:
2024-07-17 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486623
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-02-06
Brief Title:
Effect of Supplementation With Anthocyanins on Iron Metabolism in Female Swimmers
Sponsor:
Poznan University of Physical Education
Organization:
Poznan University of Physical Education
Study Overview
Official Title:
Effect of Supplementation With Anthocyanins Contained in Black Chokeberry Aronia Melanocarpa on Selected Indicators of Iron Metabolism in Female Swimmers
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study included 8-weeks supplementation of black chokeberry extract with 18 standardization of the anthocyanins content dose 2200 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
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
Detailed Description:
This study included 8-weeks supplementation of black chokeberry extract with 18 standardization of the anthocyanins content dose 2200 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
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
The research is going to be carried out as a medicinal experiment with tissue interference approval of Research Ethics Committee 53822 of 06232022 with changes 22123 of 03092023 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
1 Menstrual cycle control by application Menstrual Tracker Period Calendar and surveys before swimming test
2 Body composition analysis TANITA MC-780 S MA
3 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
1 iron status problems iron hepcidin erythroferrone total iron-binding capacity unsaturated iron-binding capacity ferritin transferrin
2 oxidative stress total antioxidant capacity
3 immunological indicators interleukins IL-6 IL-2 IL-10 C-reactive protein
4 hormonal balance progesterone estradiol luteinizing hormone follicle-stimulating hormone
5 other lactic acid myoglobin hypoxanthine
Blood samples were collected from the elbow vein into two 4-ml tubes to obtain serum and centrifuged at 3000 rpn and into 27-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 mmoll Other measurements were determined using ELISA kits DRG Medtek
4 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
5 Supplementation of black chokeberry - nearly 56-days supplementation of black chokeberry extract with 18 standardization of the anthocyanins content connection with menstrual cycle phaseThe 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
C Second term of the study
1 Menstrual cycle control by application Menstrual Tracker Period Calendar and surveys before swimming test
2 Body composition analysis TANITA MC-780 S MA
3 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
1 iron status problems iron hepcidin erythroferrone total iron-binding capacity unsaturated iron-binding capacity ferritin transferrin
2 oxidative stress total antioxidant capacity
3 immunological indicators interleukins IL-6 IL-2 IL-10 C-reactive protein CRP
4 hormonal balance progesterone estradiol luteinizing hormone LH follicle-stimulating hormone FSH
5 other lactic acid myoglobin hypoxanthine
Blood samples were collected from the elbow vein into two 4-ml tubes to obtain serum and centrifuged at 3000 rpn and into 27-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 mmoll Other measurements were determined using ELISA kits DRG Medtek
4 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
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
The research is going to be carried out as a medicinal experiment with tissue interference approval of Research Ethics Committee 53822 of 06232022 with changes 22123 of 03092023 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
1 Menstrual cycle control by application Menstrual Tracker Period Calendar and surveys before swimming test
2 Body composition analysis TANITA MC-780 S MA
3 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
1 iron status problems iron hepcidin erythroferrone total iron-binding capacity unsaturated iron-binding capacity ferritin transferrin
2 oxidative stress total antioxidant capacity
3 immunological indicators interleukins IL-6 IL-2 IL-10 C-reactive protein
4 hormonal balance progesterone estradiol luteinizing hormone follicle-stimulating hormone
5 other lactic acid myoglobin hypoxanthine
Blood samples were collected from the elbow vein into two 4-ml tubes to obtain serum and centrifuged at 3000 rpn and into 27-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 mmoll Other measurements were determined using ELISA kits DRG Medtek
4 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
5 Supplementation of black chokeberry - nearly 56-days supplementation of black chokeberry extract with 18 standardization of the anthocyanins content connection with menstrual cycle phaseThe 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
C Second term of the study
1 Menstrual cycle control by application Menstrual Tracker Period Calendar and surveys before swimming test
2 Body composition analysis TANITA MC-780 S MA
3 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
1 iron status problems iron hepcidin erythroferrone total iron-binding capacity unsaturated iron-binding capacity ferritin transferrin
2 oxidative stress total antioxidant capacity
3 immunological indicators interleukins IL-6 IL-2 IL-10 C-reactive protein CRP
4 hormonal balance progesterone estradiol luteinizing hormone LH follicle-stimulating hormone FSH
5 other lactic acid myoglobin hypoxanthine
Blood samples were collected from the elbow vein into two 4-ml tubes to obtain serum and centrifuged at 3000 rpn and into 27-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 mmoll Other measurements were determined using ELISA kits DRG Medtek
4 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None