NCT06271434

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 23, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2024

Completed
Last Updated

March 18, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

February 14, 2024

Last Update Submit

March 15, 2024

Conditions

Keywords

endotoxingastrointestinal symtomsgut permeability

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

  • Food intake

    day before the test, morning before the test

Study Arms (2)

Supplemented

EXPERIMENTAL

(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

Control

EXPERIMENTAL

receiving placebo Intervention: Drug: Placebo

Dietary Supplement: Placebo

Interventions

THYROX (Atlantic krill oilDIETARY_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.

Supplemented
PlaceboDIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Thyroxine

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Anna Skarpańska-S, professor

    Poznan University of Physical Education

    STUDY DIRECTOR

Central Study Contacts

Hanna Dziewiecka, Msc

CONTACT

Anna Skarpańska-Stejnborn, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Triple
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: All competitors will be randomly divided into two groups (double-blind): A. supplemented (n = 15), who will receive one capsule of a supplement called THYROX (Atlantic krill oil) four times a day. B. control (n = 15) receiving placebo. The supplementation period will be six weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2024

First Posted

February 21, 2024

Study Start

March 23, 2024

Primary Completion

June 24, 2024

Study Completion

June 24, 2024

Last Updated

March 18, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share