Effect of Krill Oil Supplementation on Red Blood Cell Physiology Against Changes in Markers of Iron Metabolism.

NCT06151548 | Unknown Phase 4 DMC

• 1 other identifier: jcichonwozniakZWKF
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Red Blood Cell Disorder; Oxidative Stress; Iron Metabolism Disorders

Outcome Measures

Primary Outcomes (7)

• 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).

  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.

  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.

  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

  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

  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

  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.

  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.

Study Arms (2)

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.

Drug: THYROX (Atlantic krill oil).

control

EXPERIMENTAL

receiving placebo

Drug: Placebo

Interventions

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.

supplemented

Placebo DRUG

The control capsules will be made of olive oil of equal size and color.

control

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• training experience a minimum of five years
• minimum training time per week 240 minutes
• all competitors qualified for the Polish Youth Rowing Team

You may not qualify if:

• health problems,
• antibiotic therapy,
• taking other supplements during the study period or a month earlier

Sponsors & Collaborators

• Poznan University of Physical Education: lead

Study Sites (1)

Poznań University of Physical Education

Poznan, 61-871, Poland

RECRUITING

MeSH Terms

Conditions

Iron Metabolism Disorders

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Justyna Cichoń-Woźniak, msc

CONTACT

+48 693188023; cichonjustyna95@gmail.com

Anna Skarpańska-Stejnborn, Professor

CONTACT

a.skarpanska@awf-gorzow.edu.pl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: the Polish Youth Rowing Team
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 30, 2023
• Study Start: March 23, 2024
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: March 19, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)