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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06403241
Other study ID # Rowerscometetive2023
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date June 30, 2023

Study information

Verified date June 2023
Source Poznan University of Physical Education
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date June 30, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 23 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Poland Poznan University of Physical Education, Faculty of Sport Sciences in Gorzow Gorzów Wielkopolski Lubuskie

Sponsors (1)

Lead Sponsor Collaborator
Poznan University of Physical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 energy energy [kcal ]of food intake measured by food diary whole day (24hours) before test, in the morning before the test
Secondary protein protein [g ]of food intake measured by food diary whole day (24hours) before test, in the morning before the test
Secondary fat fat [g ]of food intake measured by food diary whole day (24hours) before test, in the morning before the test
Secondary carbohydrate carbohydrate [g ]of food intake measured by food diary whole day (24hours) before test, in the morning before the test
Secondary glucose glucose [g ]of food intake measured by food diary whole day (24hours) before test, in the morning before the test
Secondary lactose lactose [g ]of food intake measured by food diary whole day(24hours) before test, in the morning before the test
Secondary saccharose saccharose [g ]of food intake measured by food diary whole day (24hours) before test, in the morning before the test
Secondary fructose fructose [g ]of food intake measured by food diary whole day (24hours) before test, in the morning before the test
Secondary fiber fiber [g ]of food intake measured by food diary whole day (24hours) before test, in the morning before the test
Secondary Body mass 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
Secondary Body fat 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
Secondary Total body water 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
Secondary Lean body mass 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
Secondary height [cm] measured by high meter in the morning before the test up to 1 hour after getting up
Secondary self reported gastrointestinal scale 10 point scale up to 1 hours after the test
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