Skip to main content
OpenTrials
Completed

NCT Number: NCT06403241

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endothelial Dysfunction Bacteremia Behavior Endotoxemia Infections Inflammation Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Toxemia

Age range

18 year–23 year

Sex eligibility

Male

Study type

Observational

Primary location

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

Gorzów Wielkopolski, Lubusz Voivodeship, 66-400, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2000 meter ergometer test

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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

Secondary outcomes

  1. energy

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

    energy [kcal ]of food intake measured by food diary

  2. protein

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

    protein [g ]of food intake measured by food diary

  3. fat

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

    fat [g ]of food intake measured by food diary

  4. carbohydrate

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

    carbohydrate [g ]of food intake measured by food diary

  5. glucose

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

    glucose [g ]of food intake measured by food diary

  6. lactose

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

    lactose [g ]of food intake measured by food diary

  7. saccharose

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

    saccharose [g ]of food intake measured by food diary

  8. fructose

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

    fructose [g ]of food intake measured by food diary

  9. fiber

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

    fiber [g ]of food intake measured by food diary

  10. 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).

  11. 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).

  12. 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).

  13. 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).

  14. height

    Time frame: in the morning before the test up to 1 hour after getting up

    [cm] measured by high meter

  15. self reported gastrointestinal scale

    Time frame: up to 1 hours after the test

    10 point scale

Sponsors and collaborators

Lead sponsor

Poznan University of Physical Education

Other

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 7, 2024
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.