InTerlaboratory Evaluation of a GastroIntestinal Activity ErgoMeterTest in Non-intense Trained PersOns

Completed

Conditions: gastrointestinal activity
gastrointestinal function
10017947

Registration Number: NL-OMON45536

Lead Sponsor: Hogeschool Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

-Male
-Generally healthy
-Recreational athlete with at least two years of cycling experience of at least twice a week
-18-35 years old
-Meeting criteria of valid max-test
-Body mass index (BMI) 18.5-25 kg/m2
-Veins suitable for blood sampling at inspection

Exclusion Criteria

-Diagnosed with an immune disease such as diabetes, coeliac disease, rheumatoid arthritis
-Diagnosed with an gastro-intestinal disease such as Crohn*s disease, colitis ulcerosa,
irritable bowel syndrome
-abnormal ECG, e.g. an aberrant QT time
-Allergies
-Smoking
-Use of hard drugs
-Use of pre- and probiotics
-(Chronic) use of specific medicines:
*chronic use of NSAIDs: aspirin, ibuprofen, corticosteroids
*chronic use of antidepressiva, antacids (Rennie), benzodiazepines (Valium)
* drugs against abdominal pain and cramping (e.g.buscopan, imodium),
-Participation in other scientific studies within 1 month before the preliminary testing
-Blood donation six weeks prior to the start of the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The relative changes in blood of iFABP (intestinal function), lymphocytes,<br /><br>leukocytes, monocytes (immune response). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The relative changes in blood, urine and saliva of several markers of<br /><br>intestinal function, immune responsiveness and general physiology: e.g.<br /><br>cytokines, RNA-profiling of bloodcells, cortisol, aminoacids, sugars. </p><br>