Red Blood Cell DisorderPhase 4NCT06151548
Effect of Krill Oil Supplementation on Red Blood Cell Physiology Against Changes in Markers of Iron Metabolism.
A Phase 4 study testing THYROX (Atlantic krill oil). in people with Red Blood Cell Disorder and Oxidative Stress, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
Research group: the research will be conducted in a homogeneous group of professional rowers (N=30), 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… Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Red Blood Cell Disorder, Oxidative Stress, Iron Metabolism Disorders
- What is being tested?
- THYROX (Atlantic krill oil).
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 23 Mar 2024to 24 Jun 2024
- Phase
- Phase 4
- 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 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- training experience a minimum of five years
- minimum training time per week 240 minutes
- all competitors qualified for the Polish Youth Rowing Team
Who cannot join
- health problems,
- antibiotic therapy,
- taking other supplements during the study period or a month earlier
Trial locations and contacts
1 site in 1 country.
Anna Skarpańska-Stejnborn, Professor contact
Poland1 site, 1 recruiting
- Recruiting
Poznań University of Physical Education
Poznan, 61-871
Justyna Cichoń-Woźniak, msc, 693188023 ext. +48, cichonjustyna95@gmail.com
Anna Skarpańska-Stejnborn, professor
About this study
Research group: the research will be conducted in a homogeneous group of professional rowers (N=30), 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.
Read more
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.
Read the detailed description
All competitors will be randomly divided into two groups (double-blind):
- 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 mg.The supplementation period will be six weeks.
- 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.
- Polyethylene tubes (2.7ml) containing dipotassium ethylenediaminetetraacetic acid (EDTAK2) anticoagulant will be used for the following tests:
- 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).
- 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.
- 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.
- 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:
- using the ELISA method by the test manufacturer's 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.
- 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.
- The lactate (La) concentration will be determined from the capillary blood immediately after collection using a commercially available kit (Dr. Lange, Germany).
- Being tested
- THYROX (Atlantic krill oil)., Placebo
- Medical subject headings
- Iron Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THYROX (Atlantic krill oil).Drug
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 mg.
PlaceboDrug
The control capsules will be made of olive oil of equal size and color.
| Study group | Role | What they receive |
|---|---|---|
| supplemented | Experimental | (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 mg.
The supplementation period will be six weeks. Receives: Drug: THYROX (Atlantic krill oil). |
| control | Experimental | receiving placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
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.
Measured: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
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.
Measured: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
markers of oxidative stress
4-Hydroxynonenal (4-HNE), Total Antioxidant Capacity (TAC), Heme oxygenase 1 (HO-1)and 8-Isoprostane. ELISA method by the test manufacturer's instructions
Measured: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
iron status parameters
hepcidin, soluble transferrin receptor, ferritin erythroferrone and lactoferrin. ELISA method by the test manufacturer's instructions
Measured: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
indicators of muscle damage
mioglobin. ELISA method by the test manufacturer's instructions
Measured: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
The iron and TIBC
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.
Measured: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start23 Mar 2024 (estimated)
- Primary completion24 Jun 2024 (estimated)
- Study completion24 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Red Blood Cell DisorderStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All competitors will be randomly divided into two groups (double-blind): A. supplemented (n = 15), who will receive three times a day one capsule of a supplement called THYROX (Atlantic krill oil). B. control (n = 15) receiving placebo. The supplementation period will be six weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151548
- Sponsor's protocol ID
- jcichonwozniakZWKF
- Status last verified
- Nov 2023
- First submitted
- 21 Nov 2023
- Last updated
- 19 Mar 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 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Krill Oil Supplementation on Red Blood Cell Physiology Against Changes in Markers of Iron Metabolism.
- ClinicalTrials.gov ID
- NCT06151548
- Acronym / sponsor ID
- jcichonwozniakZWKF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 23 Mar 2024 (estimated)
- Primary completion
- 24 Jun 2024 (estimated)
- Study completion
- 24 Jun 2024 (estimated)
- First posted
- 30 Nov 2023 (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.
Research group: the research will be conducted in a homogeneous group of professional rowers (N=30), 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.
Detailed description
All competitors will be randomly divided into two groups (double-blind):
- 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 mg.The supplementation period will be six weeks.
- 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.
- Polyethylene tubes (2.7ml) containing dipotassium ethylenediaminetetraacetic acid (EDTAK2) anticoagulant will be used for the following tests:
- 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).
- 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.
- 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.
- 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:
- using the ELISA method by the test manufacturer's 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.
- 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.
- The lactate (La) concentration will be determined from the capillary blood immediately after collection using a commercially available kit (Dr. Lange, Germany).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- All competitors will be randomly divided into two groups (double-blind): A. supplemented (n = 15), who will receive three times a day one capsule of a supplement called THYROX (Atlantic krill oil). B. control (n = 15) receiving placebo. The supplementation period will be six weeks.
| Arm | Type | Receives |
|---|---|---|
| supplemented | Experimental | Drug: THYROX (Atlantic krill oil).(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 mg. The supplementation period will be six weeks. |
| control | Experimental | Drug: Placeboreceiving placebo |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- training experience a minimum of five years
- minimum training time per week 240 minutes
- all competitors qualified for the Polish Youth Rowing Team
Key exclusion criteria (3 listed)
- health problems,
- antibiotic therapy,
- taking other supplements during the study period or a month earlier
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 |
|---|---|---|
| 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 mg. | Drug | supplemented |
| PlaceboThe control capsules will be made of olive oil of equal size and color. | Drug | control |
Primary outcome
complete blood count
Time frame: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
(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).
a manual blood smear
Time frame: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
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.
reticulocyte count
Time frame: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
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.
markers of oxidative stress
Time frame: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
4-Hydroxynonenal (4-HNE), Total Antioxidant Capacity (TAC), Heme oxygenase 1 (HO-1)and 8-Isoprostane. ELISA method by the test manufacturer's instructions
iron status parameters
Time frame: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
hepcidin, soluble transferrin receptor, ferritin erythroferrone and lactoferrin. ELISA method by the test manufacturer's instructions
indicators of muscle damage
Time frame: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
mioglobin. ELISA method by the test manufacturer's instructions
The iron and TIBC
Time frame: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 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.
Anna Skarpańska-Stejnborn, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing THYROX (Atlantic krill oil). in people with Red Blood Cell Disorder and Oxidative Stress, 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 3 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: status not confirmed, as of the sponsor's last update on 19 Mar 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justyna Cichoń-Woźniak, msc (+48 693188023, cichonjustyna95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete blood count (time frame: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.). The study lists 7 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 19 Mar 2024.