Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06151548
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2023-11-21
Brief Title:
Effect of Krill Oil Supplementation on Red Blood Cell Physiology Against Changes in Markers of Iron Metabolism
Sponsor:
Poznan University of Physical Education
Organization:
Poznan University of Physical Education
Study Overview
Official Title:
Effect of Krill Oil Supplementation on Red Blood Cell Physiology Against Changes in Markers of Iron Metabolism
Status:
RECRUITING
Status Verified Date:
2023-11
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:
Research group the research will be conducted in a homogeneous group of professional rowers N30 all competitors qualified for the Polish Youth Rowing Team
aged 18 - 24 because the age group must be homogeneous
the size of the group is about thirty people which in the case of a homogeneous group will enable statistical analyzes to be conducted
Rowing performance test at the beginning and at the end of the training camp participants will perform a test on a rowing ergometer Concept II USA each subject will have to cover a distance of 2000 m in the shortest possible time which is the distance starting in rowing competitions The results of both tests will be considered in the selection for the championship team therefore athletes will be well motivated to perform both tests with maximum effort
The investigators set a research hypothesis that supplementation with krill oil may have a beneficial effect on athletes by limiting lipid peroxidation and inhibiting ferroptosis which in consequence may lead to red blood cell membrane protection
aged 18 - 24 because the age group must be homogeneous
the size of the group is about thirty people which in the case of a homogeneous group will enable statistical analyzes to be conducted
Rowing performance test at the beginning and at the end of the training camp participants will perform a test on a rowing ergometer Concept II USA each subject will have to cover a distance of 2000 m in the shortest possible time which is the distance starting in rowing competitions The results of both tests will be considered in the selection for the championship team therefore athletes will be well motivated to perform both tests with maximum effort
The investigators set a research hypothesis that supplementation with krill oil may have a beneficial effect on athletes by limiting lipid peroxidation and inhibiting ferroptosis which in consequence may lead to red blood cell membrane protection
Detailed Description:
All competitors will be randomly divided into two groups double-blind
A supplemented n 15 who will receive four times a day one capsule of a supplement called THYROX Atlantic krill oil The daily content of krill oil is 2000 mg including omega-3 fatty acids 350 mg EPA - 240 mg DHA - 110 mg phospholipids - 800 mg astaxanthin 200 mgThe supplementation period will be six weeks
B control n 15 receiving placebo MLB Biotrade Sp z o o Poznan Poland will produce all oil krill supplements and placebo
Measurement All determined parameters will be measured with the available equipment in the ZWKF laboratory in Gorzów Wielkopolski and using commercial assay kits Measurements will be performed by the project contractors
1 Polyethylene tubes 27ml containing dipotassium ethylenediaminetetraacetic acid EDTAK2 anticoagulant will be used for the following tests
1 complete blood count 18 parameters determined on the MYTHIC 18 hematology analyzer Orphee Medical Geneva Switzerland White blood cell indices WBC white blood cells LYM lymphocytes as a percentage LYM lymphocytes MON monocytes as a percentage MON monocytes GRA granulocytes as a percentage GRA granulocytes Red blood cell indices RBC Red Blood Cells HGB Hemoglobin HCT Hematocrit MCV Mean Corpuscular Volume MCH Mean Corpuscular Hemoglobin MCHC Mean Corpuscular Hemoglobin Concentration RDW Red Blood cells Distribution Width Platelet indices PLT Platelet MPV Mean Platelet Volume PDW Platelet Distribution Width PCT Thrombocrit
2 a manual blood smear will be made by placing a drop of blood on a slide and then spreading it with a uniform motion After drying it will be colored by the May Grunwald-Giemsa method according to the procedure The stained and fixed smear after drying will be viewed under a microscope for quantitative and qualitative assessment
3 reticulocyte count will be performed by incubating the collected blood with reticulocyte dye in the proportion specified by the manufacturer Next a smear will be made and after drying the number of cells will be counted
2 Polyethylene clotting activator tubes 9 ml will be centrifuged to separate the morphotic elements from the serum using a centrifuge 3000 rpm for 10 min The serum will be pipetted into several Eppendorf tubes which will then be frozen temp -80 C All the following biochemical parameters will be determined from the extracted serum
1 using the ELISA method by the test manufacturers instructions The designations include the flowing parameters
markers of oxidative stress 4-Hydroxynonenal 4-HNE Total Antioxidant Capacity TAC Heme oxygenase 1 HO-1 and 8-Isoprostane
iron status parameters hepcidin soluble transferrin receptor ferritin erythroferrone lactoferrin
indicators of muscle damage myoglobin
2 the iron and Total Iron Binding Capacity TIBC levels Unsaturated Iron Binding Capacity UIBC will be calculated from the formula UIBC TIBC-iron in serum will be determined using the colorimetric method on the SPECTROstar Nano reader
3 The lactate La concentration will be determined from the capillary blood immediately after collection using a commercially available kit Dr Lange Germany
A supplemented n 15 who will receive four times a day one capsule of a supplement called THYROX Atlantic krill oil The daily content of krill oil is 2000 mg including omega-3 fatty acids 350 mg EPA - 240 mg DHA - 110 mg phospholipids - 800 mg astaxanthin 200 mgThe supplementation period will be six weeks
B control n 15 receiving placebo MLB Biotrade Sp z o o Poznan Poland will produce all oil krill supplements and placebo
Measurement All determined parameters will be measured with the available equipment in the ZWKF laboratory in Gorzów Wielkopolski and using commercial assay kits Measurements will be performed by the project contractors
1 Polyethylene tubes 27ml containing dipotassium ethylenediaminetetraacetic acid EDTAK2 anticoagulant will be used for the following tests
1 complete blood count 18 parameters determined on the MYTHIC 18 hematology analyzer Orphee Medical Geneva Switzerland White blood cell indices WBC white blood cells LYM lymphocytes as a percentage LYM lymphocytes MON monocytes as a percentage MON monocytes GRA granulocytes as a percentage GRA granulocytes Red blood cell indices RBC Red Blood Cells HGB Hemoglobin HCT Hematocrit MCV Mean Corpuscular Volume MCH Mean Corpuscular Hemoglobin MCHC Mean Corpuscular Hemoglobin Concentration RDW Red Blood cells Distribution Width Platelet indices PLT Platelet MPV Mean Platelet Volume PDW Platelet Distribution Width PCT Thrombocrit
2 a manual blood smear will be made by placing a drop of blood on a slide and then spreading it with a uniform motion After drying it will be colored by the May Grunwald-Giemsa method according to the procedure The stained and fixed smear after drying will be viewed under a microscope for quantitative and qualitative assessment
3 reticulocyte count will be performed by incubating the collected blood with reticulocyte dye in the proportion specified by the manufacturer Next a smear will be made and after drying the number of cells will be counted
2 Polyethylene clotting activator tubes 9 ml will be centrifuged to separate the morphotic elements from the serum using a centrifuge 3000 rpm for 10 min The serum will be pipetted into several Eppendorf tubes which will then be frozen temp -80 C All the following biochemical parameters will be determined from the extracted serum
1 using the ELISA method by the test manufacturers instructions The designations include the flowing parameters
markers of oxidative stress 4-Hydroxynonenal 4-HNE Total Antioxidant Capacity TAC Heme oxygenase 1 HO-1 and 8-Isoprostane
iron status parameters hepcidin soluble transferrin receptor ferritin erythroferrone lactoferrin
indicators of muscle damage myoglobin
2 the iron and Total Iron Binding Capacity TIBC levels Unsaturated Iron Binding Capacity UIBC will be calculated from the formula UIBC TIBC-iron in serum will be determined using the colorimetric method on the SPECTROstar Nano reader
3 The lactate La concentration will be determined from the capillary blood immediately after collection using a commercially available kit Dr Lange Germany
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