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

NCT ID: NCT06271434

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-23
• Study Completion Date: 2024-06-24

Brief Summary

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.

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).

Conditions

Endothelial Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: EXPERIMENTAL

THYROX (Atlantic krill oil

Intervention Type: DIETARY_SUPPLEMENT

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.

Control

receiving placebo Intervention: Drug: Placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Poznan University of Physical Education

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Skarpańska-S, professor

Role: STUDY_DIRECTOR

Poznan University of Physical Education

Central Contacts

Hanna Dziewiecka, Msc

Role: CONTACT

hannadziewiecka@gmail.com

606880282 ext. +48

Anna Skarpańska-Stejnborn, professor

Role: CONTACT

Other Identifiers

Olej z kryla/jelita

Identifier Type: -

Identifier Source: org_study_id