To study the adaptive capacity in relevant metabolic processes after a high fat challenge and oral glucose challenge in humans. It is expected that a test method that is generally applicable in clinical food research can be developed.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
glucagon, GLP-1, leptin, insulin, adiponectin, GIP, C-peptide, glutathione
ratio, C reactive protein, SAA, sICAM, sVCAM and metabolites.
Oxygen consumption and carbon dioxide production.
Secondary outcome
free fatty acids, immunological parameters (IL-1b, IL-6, IL-8, IL-18, TNFα,
MCP-1, E-selectin, P-selectin, PAI1, IL1Ra, CXCL9, CXCL10) and others (leptin,
cortisol, , PYY, LPS, CK18, nitrite/nitrate ratio).
Background summary
Nutritional science has had difficulty to illustrate specific health-benefit
effects related to diet. One of the reasons is that it is difficult to assess
changes in health status. The response to challenge tests may be used to
develop biomarkers for the dietary effects on physiological function. The
current clinical study aims to investigate whether a high fat challenge test
with generally available ingredients can be developed. It is expected that it
can quantify the adaptive capacities in the most relevant metabolic processes.
Study objective
To study the adaptive capacity in relevant metabolic processes after a high fat
challenge and oral glucose challenge in humans. It is expected that a test
method that is generally applicable in clinical food research can be developed.
Study design
This is an explorative randomized cross-over study of 20 healthy males and 20
males with type 2 diabetes mellitus. Both groups will be given the high fat
challenege ( OLTT) or the oral glucose tolerance challenge ( OGTT) at fasting
condition on two different study days. Wash-out between study days will be at
least 2 days.
Intervention
Two dietary challenge tests will be applied: an oral lipid tolerance test
(OLTT) and an oral glucose tolerance test (OGTT). The OLTT is a drink of about
500 mL which consists of a mixture of 75g glucose syrup, 20g Protifar
(Nutricia), 60g palm oil and 64g water. The oral lipid challenge drink should
be consumed within 5 minutes.
The OGTT is a drink consisting of 75 g glucose in 300mL water which has to be
consumed within 5 minutes.
Study burden and risks
The risks associated with participation to this study are minimal. The medical
screening may result in unexpected findings. See E9a.
Utrechtseweg 48
Zeist 3700AJ
NL
Utrechtseweg 48
Zeist 3700AJ
NL
Listed location countries
Age
Inclusion criteria
Males, aged 30 to 55 years.
20 healthy volunteers are defined based on 1) Medical history evaluation; 2) Physical examination; 3) results of the prestudy laboratory tests; 4) Body mass index (BMI): 20-25 kg/m2.
20 Type 2 Diabetes, BMI: 25.1-30 kg/m2, willing to stop antidiabetic medication.
Exclusion criteria
1)Uncontrolled bloodpresseure: systolic blood pressure >= 150 mmHg; diastolic blood pressure >= 95mmHg.
2)Use of medication that might interfere with parameters to be measured with one of the challenge tests, with the exception of oral antidiabetic drugs. ( use beta blockers, statins, antidiabetic drugs during the study).
3)Smoking
4)physical activity (more than 6 hours per week)
5)unexplained weight loss or gain of > 4 kg in the month prior to the screening
6)followed slimming or medically prescribed diet
7) food allergy or sensitivity
8) For diabetic subjects, fasting glucose < 10mmol/L after stopping metformin for one week.
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 | NL41396.058.12 |