Primary Objective: To determine effects of less exercise,30 min 70% Wmax, on intestinal function and immune response in blood, urine and saliva.Secondary Objective: Interlaboratory evaluation of the ergometertest performed in Groningen and Utrecht…
ID
Source
Brief title
Condition
- Gastrointestinal disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The relative changes in blood of iFABP (intestinal function), lymphocytes,
leukocytes, monocytes (immune response).
Secondary outcome
The relative changes in blood, urine and saliva of several markers of
intestinal function, immune responsiveness and general physiology: e.g.
cytokines, RNA-profiling of bloodcells, cortisol, aminoacids, sugars.
Background summary
General health seems strongly related to intestinal health and food intake.
Food companies are interested in standardized models to test health-promoting
effects of nutrition and related products (naturally occurring health-promoting
products) to support health claims according the regulations of the European
Food and Safety Authority (EFSA). For this human data are crucial if not
obligatory. However, ergometer tests used to test effects of exercise have not
yet been properly validated for nutritional studies, for instance with regard
to lab transferability. In addition, a validated set of relevant e.g.
function-related, biomarkers is not available, nor is clear how the extent of
exercise intensity influences these biomarkers. Currently, a high intense
exercise protocol of 70% Wmax is used, but this protocol is too intense for
less fit individuals, e.g. elderly, obesity patients. A standardized bicycle
ergometer test can be used to perform nutrition intervention studies with
less-fit individuals.
Study objective
Primary Objective:
To determine effects of less exercise,30 min 70% Wmax, on intestinal function
and immune response in blood, urine and saliva.
Secondary Objective:
Interlaboratory evaluation of the ergometertest performed in Groningen and
Utrecht on parameters of intestinal function and immune response .
Study design
The study has a randomized cross-over design.
Each subject will complete 4 different experimental protocols, 1 at rest
without exercise and 3 with exercise protocols:
1. 60 min at 70% of Wmax
2. 30 min at 70% of Wmax
3. 60 min at 50% of Wmax
4. 60 min rest (control)
Beforehand Wmax of the subjects will be determined by the VO2 max test.
Intervention
-Ingestion of a multisugar and glutamin/alanin solution
-Exercise with different load
Study burden and risks
The risks for the subjects related to this study are minor. Prior to the
maximal capacity test, an ECG in rest will be taken to make sure that there are
neither abnormalities or aberrant QT intervals. The exercise that has to be
performed is moderate to intense and will be well tolerated within this group
of participants, i.e. recreationally trained cyclists. There is a small risk of
bruising due to the blood sampling procedures. The ingestion of the test
products is not associated with an additional risk and is well tolerated.
There is no direct health benefit for the subjects (recreationally trained
cyclists) but the values of Wmax and VO2max can be of interest for their
trainingsscheme.
Heidelberglaan 7
Utrecht 3584 CS
NL
Heidelberglaan 7
Utrecht 3584 CS
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58313.081.16 |