- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06403241
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
Completed
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
-
-
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
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
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
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.
Investigators
- 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)
May 1, 2023
Primary Completion (Actual)
June 1, 2023
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
April 26, 2024
First Submitted That Met QC Criteria
May 6, 2024
First Posted (Actual)
May 7, 2024
Study Record Updates
Last Update Posted (Actual)
May 7, 2024
Last Update Submitted That Met QC Criteria
May 6, 2024
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID 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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