The Association Between Food Timing and Composition on Gastrointestinal Injury, Stress Hormone and Gastrointestinal Complains.

May 6, 2024 updated by: Poznan University of Physical Education

The Association Between Food Timing and Composition on Gastrointestinal Injury, Stress Hormone and Gastrointestinal Complains in Elite Rowers After 2000m Ergometer Test - an Observational Study.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The research protocol includes detailed food intake analysis, including timing and composition, markers related to the neuroendocrine pathway cortisol, and observations of individually experienced symptoms. Moreover, the study also explores intestinal injury and endotoxemia parameters, such as I-FABP, CLDN-3, and LBP. As a first goal, this study investigates the timing and composition of food intake concerning changes in gut integrity, cortisol levels, and gastrointestinal symptoms. Investigators explored whether an athlete's nutritional intake influences any GI disturbance induced by high-intensity exercise. As a second goal, Investigators tried to connect symptoms and markers from both pathways with gastrointestinal complaints. Investigators hypothesised that cortisol levels would be more profound than other studied parameters in gastrointestinal symptoms.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Lubuskie
      • Gorzów Wielkopolski, Lubuskie, Poland, 66-400
        • Poznan University of Physical Education, Faculty of Sport Sciences in Gorzow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Male rowers age 18 - 22 years.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
I-FABP (intestinal fatty acid binding protein)to measure epithelial wall injury
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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 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
Time Frame: 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
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
Time Frame: 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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
energy
Time Frame: whole day (24hours) before test, in the morning before the test
energy [kcal ]of food intake measured by food diary
whole day (24hours) before test, in the morning before the test
protein
Time Frame: whole day (24hours) before test, in the morning before the test
protein [g ]of food intake measured by food diary
whole day (24hours) before test, in the morning before the test
fat
Time Frame: whole day (24hours) before test, in the morning before the test
fat [g ]of food intake measured by food diary
whole day (24hours) before test, in the morning before the test
carbohydrate
Time Frame: whole day (24hours) before test, in the morning before the test
carbohydrate [g ]of food intake measured by food diary
whole day (24hours) before test, in the morning before the test
glucose
Time Frame: whole day (24hours) before test, in the morning before the test
glucose [g ]of food intake measured by food diary
whole day (24hours) before test, in the morning before the test
lactose
Time Frame: whole day(24hours) before test, in the morning before the test
lactose [g ]of food intake measured by food diary
whole day(24hours) before test, in the morning before the test
saccharose
Time Frame: whole day (24hours) before test, in the morning before the test
saccharose [g ]of food intake measured by food diary
whole day (24hours) before test, in the morning before the test
fructose
Time Frame: whole day (24hours) before test, in the morning before the test
fructose [g ]of food intake measured by food diary
whole day (24hours) before test, in the morning before the test
fiber
Time Frame: whole day (24hours) before test, in the morning before the test
fiber [g ]of food intake measured by food diary
whole day (24hours) before test, in the morning before the test
Body mass
Time Frame: in the morning before the test up to 1 hour after getting up
Body mass [kg] measured by electronic scale to the nearest 0,05 kg (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan).
in the morning before the test up to 1 hour after getting up
Body fat
Time Frame: in the morning before the test up to 1 hour after getting up
Body fat [%] measured by electronic scale (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan).
in the morning before the test up to 1 hour after getting up
Total body water
Time Frame: in the morning before the test up to 1 hour after getting up
Body fat [%] measured by electronic scale (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan).
in the morning before the test up to 1 hour after getting up
Lean body mass
Time Frame: in the morning before the test up to 1 hour after getting up
Lean body mass [kg] measured by electronic scale (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan).
in the morning before the test up to 1 hour after getting up
height
Time Frame: in the morning before the test up to 1 hour after getting up
[cm] measured by high meter
in the morning before the test up to 1 hour after getting up
self reported gastrointestinal scale
Time Frame: up to 1 hours after the test
10 point scale
up to 1 hours after the test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poznan University of Physical Education

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Anna Skarpańska-Stejnborn, professor, Poznan University of Physical Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Rowerscometetive2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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