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临床试验/NCT06151548
NCT06151548招募中4 期

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

Poznan University of Physical Education1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
complete blood count

研究概览

简要总结

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.

详细描述

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 mg.The 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 (2.7ml) containing dipotassium ethylenediaminetetraacetic acid (EDTAK2) anticoagulant will be used for the following tests:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

the Polish Youth Rowing Team

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: THYROX (Atlantic krill oil). (Drug)

control

Experimental

receiving placebo

干预措施: Placebo (Drug)

结局指标

主要结局

complete blood count

时间窗: 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

时间窗: 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.

markers of oxidative stress

时间窗: 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

indicators of muscle damage

时间窗: 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

时间窗: 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.

reticulocyte count

时间窗: 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.

iron status parameters

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Poznan University of Physical Education
申办方类型
Other
责任方
Sponsor

研究点 (1)

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