The major research objective is to assess the potential of 1H-MRS to follow IHL and IMCL dynamics after a single meal.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change of IHL and IMCL concentrations in the late postprandial phase,
compared to baseline measurement after an overnight fast.
Secondary outcome
We also aim to investigate whether the addition of protein to a high fat
breakfast (HFP) results in a reduced postprandial accumulation of lipids when
compared to a high fat breakfast (HF) alone.
Background summary
Fat accumulation in non-adipose tissue, such as liver and muscle, is associated
with reduced insulin sensitivity and cardiovascular disease. Little is known
about the dietary determinants and the time course of ectopic fat accumulation
and therefore the general aim of this project is to develop and validate
methodology to follow postprandial hepatic and muscular lipid retention. Proton
Magnetic Resonance Spectroscopy (1H-MRS) is a well-established tool for
noninvasive quantification of intrahepatic lipids (IHL) and intramyocellular
lipids (IMCL). Previous studies have suggested a relatively rapid regulation of
IHL and IMCL levels, indicated by changes in these total lipid pools after high
fat diets of 3 or 4 days. Although IHL and IMCL levels seem to change rapidly,
data on IHL and IMCL levels after a single meal are lacking.
Study objective
The major research objective is to assess the potential of 1H-MRS to follow IHL
and IMCL dynamics after a single meal.
Study design
In a randomized crossover study, IHL and IMCL concentrations will be determined
after a high-energy HF breakfast and after a high-energy HFP breakfast, using
1H-MRS at various time points in a postprandial period of 6 hours.
Intervention
Subjects will report to the university at 7.00 h, after a 9 hours (overnight)
fasting period. They will undergo a 1H-MRS scan to determine baseline IHL and
IMCL levels. Subsequently the subjects will consume either a high-energy HF
breakfast or a high-energy HFP breakfast, and during the late postprandial
phase (3h and 5h) IHCL and IMCL levels will be measured again. In addition to
the MRS measurements, seven blood samples will be collected at different time
points.
Study burden and risks
Subjects will have to come to the university three times. The first time the
subjects will be screened to access eligibility, which will include filling in
of a medical history questionnaire and a physical activity questionnaire and
measurement of height and body weight. Body composition will also be accurately
determined by hydrostatic weighing.
During the second and third visit the MRS measurements will be performed.
Subjects are asked to report to the university at 7.00 AM. A first MRS scan of
liver and muscle is performed prior to the breakfast. At 8.15 AM the subject
will have either a high-energy HF breakfast or a high-energy HFP breakfast. The
breakfast will consist of sausage rolls. The added proteins will be consumed
as a protein powder dissolved in water. Three and five hours after the
breakfast, again IHCL and IMCL levels will de determined. Blood samples will
also be taken, at different timepoints in between the MR measurements. This
means a total of 3 MRS scans and 7 blood samples.
The experimental procedures are without significant risks. MRS is a safe
procedure (no ionizing radiation), with no known health risk as long as none of
the exclusion criteria is met. There is a chance that MRI reveals an unexpected
medical condition, of which the subject will be informed. His physician will
also be informed.
P.O. Box 5800 -
Maastricht 6202 AZ
NL
P.O. Box 5800 -
Maastricht 6202 AZ
NL
Listed location countries
Age
Inclusion criteria
- Age 18-65 years
- Healthy
- Stable dietary habits
- No use of medication
- Lean subjects: BMI 18-25 kg/m2
- Obese subjects: BMI 30-35 kg/m2
Exclusion criteria
- Any medical condition requiring treatment and/or medication use
- Alcohol consumption of more than 20 g per day (± 2 units)
- Smoking
- Unstable body weight (weight gain or loss > 3 kg in the past three months)
- Participation in another biomedical study within 1 month prior to the screening visit
- Contraindications for MRI scan (cochlear implant, pacemaker, claustrophobia)
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 | NL40593.068.12 |