The main objective of the present study is to investigate whether it is possible to use the VOC pattern in exhaled air as a parameter of metabolism of lipids.Primary Objective: To investigate the difference in postprandial change in volatile organic…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
metabolisme van vetten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study objective is the postprandial change in VOCs from exhaled air.
This parameter will be studied to gain insight in the the intra-subject
variation of VOC profile in exhaled air in a fasted state and after consumption
of a low- or high-fat drink.
Secondary outcome
The secondary study objectives are parameters (which will be investigated
during part II of the study) to investigate whether specific VOCs in exhaled
air after fat consumption can be linked to postprandial VOCs in blood; and to
investigate whether specific VOCs in exhaled air after fat consumption can be
linked to postprandial (metabolic) parameters.
Therefore, the secondary parameters are:
* Postprandial change in VOCs from blood samples
* Blood levels: as indication of fat absorption and metabolism
o Plasma lipid profile over 5 hours after consumption of milk drinks (level of
free fatty acids (FFA), level of LDL, HDL and VLDL, total cholesterol,
triglycerides and cholesterol in chylomicron-rich fractions and size of those
fractions)
o Apolipoprotein B48
o Apolipoprotein A-IV
o Glycated haemoglobin (only at baseline)
o Etc.
* Respiratory exchange ratio (RER) (ratio of CO2 production and O2
consumption). The CO2 produced and O2 consumed by participants will be measured
in resting condition, pre- and 5 hours postprandial with the usage of a
ventilated hood system (Max II Metabolic Cart, AEI technologies).
Background summary
Currently, the effects of nutrition or specific food components, including
those on absorption or metabolism, are mostly studied via parameters in blood
samples. To reduce the burden for participants of nutritional intervention
studies, there is a high need for non-invasive methods. Exhaled air contains
large numbers of volatile organic compounds (VOCs) that may be derived from the
body*s internal metabolism. So this seems to be an interesting, non-invasive
parameter.
Study objective
The main objective of the present study is to investigate whether it is
possible to use the VOC pattern in exhaled air as a parameter of metabolism of
lipids.
Primary Objective:
To investigate the difference in postprandial change in volatile organic
compounds (VOCs) pattern from exhaled air, between a dairy drink with 0.1% fat
and a dairy drink with 10% fat, and investigate whether this is related to
parameters of lipid metabolism.
Secondary Objectives:
* To study the intra-subject variation of VOC profile in exhaled air in a
fasted state and after consumption of a high-fat drink
* To study differences between online and offline measurements of VOC pattern
in exhaled air
* To identify VOCs that are linked to consumption of a dairy drink
* To investigate whether a VOC pattern in exhaled air after fat consumption can
be linked to postprandial VOC pattern in blood
* To investigate whether a VOC pattern in exhaled air after fat consumption can
be linked to postprandial (metabolic) parameters.
Study design
This study will be a randomized cross-over study. This study will not be
blinded, because the taste and mouthfeel of the two drinks is very different
and will be easily recognized by the participants. The study will consist of 13
study days.
Intervention
The subjects of this study will receive, at study days 1-4 and 10, a high-fat
drink, which will be a dairy drink consisting of full cow*s milk, cream, skim
milk powder and lactose (total of 10% fat). At study days 5-10 and 12-13
participants will receive either this high-fat drink or a low-fat version of
this drink. The low-fat drink will be skimmed cow*s milk (0.1% fat). A total
of 500 ml of the milk drink will be consumed.
Study burden and risks
A cannula will be installed to take blood samples. This might cause some
bruising and sore muscles.
De Elst 1
Wageningen 6708 WD
NL
De Elst 1
Wageningen 6708 WD
NL
Listed location countries
Age
Inclusion criteria
* Caucasian male
* 18-35 years old
* Body mass index (BMI) 22-25 kg/m2.
* Fat percentage between 8 * 15%
* Regular consumption of milk (products)
Exclusion criteria
* (symptoms of) cow*s milk allergy
* Lactose intolerance
* Metabolic diseases
* (known symptoms of) (auto)immune diseases, like diabetes
* (known symptoms of) intestinal diseases, like; irritable bowel syndrome
Intestinal malabsorption, diagnosed with celiac disease, Crohn*s disease, colitis ulcerosa, short bowel syndrome or surgical bowel interventions leading to malabsorption;
* Usage of medication
* Usage of hard drugs
* History of smoking
* Claustrophobia
* Unsuitable veins for blood sampling
* Blood donation during the two months before the start of the study
* Current participation in other scientific studies
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 | NL56722.081.16 |