NCT06403241

Brief Summary

The study aimed to check the influence of timing and composition of diet on markers of gut injury, endotoxemia and stress.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 7, 2024

Completed
Last Updated

May 7, 2024

Status Verified

June 1, 2023

Enrollment Period

1 month

First QC Date

April 26, 2024

Last Update Submit

May 6, 2024

Conditions

Keywords

athlete's dietendotoxemiacortisolgut injurygut permeabilityexercise

Outcome Measures

Primary Outcomes (5)

  • I-FABP (intestinal fatty acid binding protein)to measure epithelial wall injury

    I-FABP concentration measured in blood \[ng/ml\] using commercially available enzyme-linked immunosorbent assays

    Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 1-hour recovery period

  • Claudin to measure tight junction leakage

    Zonulin concentration measured in blood \[ng/ml\] using commercially available enzyme-linked immunosorbent assays

    Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 1-hour recovery period

  • LBP (lipopolysaccharide binding protein) to measure endotoxin

    LBP concentration measured in blood \[ug/ml\] using commercially available enzyme-linked immunosorbent assays

    Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 1-hour recovery period

  • Lactic acid to measure fatigue after the race

    Lactate concentration measured in capillary blood from earlobe \[mmol/L\] using a commercially available kit (Diaglobal, Berlin, Germany)

    Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test

  • Corisol

    Stress hormoneconcentration measured in blood \[ng/ml\] using commercially available enzyme-linked immunosorbent assays

    Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 1-hour recovery period

Secondary Outcomes (15)

  • energy

    whole day (24hours) before test, in the morning before the test

  • protein

    whole day (24hours) before test, in the morning before the test

  • fat

    whole day (24hours) before test, in the morning before the test

  • carbohydrate

    whole day (24hours) before test, in the morning before the test

  • glucose

    whole day (24hours) before test, in the morning before the test

  • +10 more secondary outcomes

Interventions

Rowers performed 2000m ergometer test.A 2,000-m time trial is a standard test used to assess performance in rowers.

Eligibility Criteria

Age18 Years - 23 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male rowers age 18 - 22 years.

You may qualify if:

  • Membership in Polish Rowing Team,
  • minimum five years of training,
  • total training time minimum of 240 minutes,
  • filling out a food diary,
  • finishing 2000-meter ergometer test.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Physical Education, Faculty of Sport Sciences in Gorzow

Gorzów Wielkopolski, Lubusz Voivodeship, 66-400, Poland

Location

MeSH Terms

Conditions

EndotoxemiaMotor Activity

Condition Hierarchy (Ancestors)

BacteremiaSepsisInfectionsToxemiaSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Anna Skarpańska-Stejnborn, professor

    Poznan University of Physical Education

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2024

First Posted

May 7, 2024

Study Start

May 1, 2023

Primary Completion

June 1, 2023

Study Completion

June 30, 2023

Last Updated

May 7, 2024

Record last verified: 2023-06

Locations