Effects of Krill Oil on Intestinal Integrity Markers in Elite Rowers.

Krill Oil Supplementation and Its Effect on Intestinal Permeability Markers in Elite Rowers.

The study aims to check the influence of krill oil on markers of intestinal injury and intoxication.

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. The sample size was confiremed in statistical analyses.

Rowing performance test will be conducted 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.

Hypotesis:

The krill oil will infleunce the gut barier integrity.

Study Overview

• Status: Not yet recruiting
• Conditions: Endothelial Dysfunction
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: THYROX (Atlantic krill oil

Detailed Description

All competitors will be randomly divided into two groups (double-blind):

A. supplemented (n = 15), who will receive one capsule of THYROX (Atlantic krill oil) four times a day.

B. control (n = 15) receiving placebo. The supplementation period will be six weeks.

Characteristic of the supplement:

THYROX (Atlantic krill oil). The daily recommended intake of krill oil is 2000 mg, which includes 350 mg of omega-3 fatty acids, 240 mg of EPA, 110 mg of DHA, 800 mg of phospholipids, and 200 mg of astaxanthin.

Placebo will be produced by MLB Bitrade Sp. z o.o., Poznan.

Measurement: The project contractors will measure all parameters using the available equipment in the ZWKF laboratory in Gorzów Wielkopolski and commercial assay kits.

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, then 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:

a food diary will be filled day before the study and in the morning before the test, markers of gut injury: I-FABP (intestinal fatty acid binding protein), CLDN-3 (claudin 3) intoxication: LBP (lipopolysaccharide binding protein) stress hormones: ACTH and cortisol will be determined using the colourimetric 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 (Diaglobal, Germany).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Skarpańska-Stejnborn, Professor
• Study Contact Backup: Name: Hanna Dziewiecka, Msc; Phone Number: +48 606880282; Email: hannadziewiecka@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• training experience of a minimum of five years,
• minimum training time per week 240 minutes,
• all competitors qualified for the Polish Youth Rowing Team,
• completing a food diary,
• finishing 2000m ergometer test.

Exclusion Criteria:

• Probiotics, prebiotics and antibiotic therapy within the last three months,
• dietary regime,
• gastrointestinal diseases,
• lactose intolerance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control; receiving placebo Intervention: Drug: Placebo	Dietary supplement: Placebo; The control capsules will be made of olive oil of equal size and color.
Experimental: Supplemented; (n = 15), who will receive one capsule of a supplement called THYROX (Atlantic krill oil) four times a day. 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. Intervention: Drug: THYROX (Atlantic krill oil).	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
I-FABP (intestinal fatty acid binding protein)	gut injury (enterocyte)	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.
CLDN-3	gut injury (tight junction)	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.
LBP (lipopolysaccharide binding protein)	endotoxin	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.
Catechyloamines, cortisol	stress hormones	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.
CD14	endotoxin	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food intake	macro and micronutrients, fluids	day before the test, morning before the test

Collaborators and Investigators

• Sponsor: Poznan University of Physical Education
• Investigators: Study Director: Anna Skarpańska-S, professor, Poznań University of Physical Education

Study record dates

Study Major Dates

• Study Start (Estimated): March 23, 2024
• Primary Completion (Estimated): June 24, 2024
• Study Completion (Estimated): June 24, 2024

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: gut permeability; endotoxin; gastrointestinal symtoms
• Other Study ID Numbers: Olej z kryla/jelita

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No