Clinical trial NCT01709643: Postprandial IHL and IMCL Measured With Proton Magnetic Resonance Spectroscopy
Official title: Postprandial Intrahepactic Lipid (IHL) and Intramyocellular Lipid (IMCL) Levels Measured With Proton Magnetic Resonance Spectroscopy (1H-MRS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial IHL and IMCL Dynamics
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Top Institute Food and Nutrition
First posted: 2012-10-18
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The major research objective is to assess the potential of Proton Magnetic Resonance Spectroscopy to follow Intrahepatic lipid and Intramyocellular lipid dynamics after a single meal. Furthermore we aim to investigate whether the addition of protein to a high fat breakfast results in a reduced postprandial accumulation of lipids when compared to a high fat breakfast alone.

Detailed description: 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 this ectopic fat accumulation. 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.

Eligibility criteria: Inclusion Criteria:

* Age 18-40 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:

  * Central nervous system aneurysm clips
  * Implanted neural stimulator
  * Implanted cardiac pacemaker of defibrillator
  * Cochlear implant
  * Iron- containing corpora aliena in the eye or brain
  * Hearing aids and artificial (heart) valves which is contraindicated for MRS
  * Claustrophobia

Primary outcomes:
measure: Difference between pre- and postprandial IHL and IMCL
timeFrame: 3 and 5 hours after high fat breakfast
Secondary outcomes:
measure: Difference between postprandial IHL and IMCL in high fat and high fat with extra protein breakfast
timeFrame: 3 and 5 hours after high fat breakfast
Other outcomes:
measure: Fat and fat free mass of subjects
timeFrame: One week before the first MR measurements
measure: Blood plasma insulin levels
timeFrame: Ten minutes prior to high fat breakfast and 0.5, 1,2,3.5,4.5,5.5 hours after the high fat breakfast
measure: Blood plasma glucose levels
timeFrame: Ten minutes prior to high fat breakfast and 0.5, 1,2,3.5,4.5,5.5 hours after the high fat breakfast
measure: Blood plasma free fatty acid level
timeFrame: Ten minutes prior to high fat breakfast and 0.5, 1,2,3.5,4.5,5.5 hours after the high fat breakfast
measure: Blood plasma triglyceride level
timeFrame: Ten minutes prior to high fat breakfast and 0.5, 1,2,3.5,4.5,5.5 hours after the high fat breakfast
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center +
Study officials:
References:
citation: Lindeboom L, Nabuurs CI, Hesselink MK, Wildberger JE, Schrauwen P, Schrauwen-Hinderling VB. Proton magnetic resonance spectroscopy reveals increased hepatic lipid content after a single high-fat meal with no additional modulation by added protein. Am J Clin Nutr. 2015 Jan;101(1):65-71. doi: 10.3945/ajcn.114.094730. Epub 2014 Nov 5.