Postprandial IHL and IMCL Measured With Proton Magnetic Resonance Spectroscopy

Not Applicable

Completed

• Conditions: Postprandial IHL and IMCL Dynamics

• Registration Number: NCT01709643
• Lead Sponsor: Maastricht University Medical Center

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.

Study Timeline

• Study Start: 2012-09
• Status Verified: 2012-10
• Study First Submitted: 2012-10-11
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-18
• Primary Completion: 2014-06
• Study Completion: 2014-09
• Last Update Submitted: 2016-09-19
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Difference between pre- and postprandial IHL and IMCL	3 and 5 hours after high fat breakfast	The primary research objective is to assess the potential of 1H-MRS to follow IHL and IMCL dynamics after a single meal in lean and obese subjects.

Secondary Outcome Measures

Name	Time	Method
Difference between postprandial IHL and IMCL in high fat and high fat with extra protein breakfast	3 and 5 hours after high fat breakfast	We 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.

Trial Locations

Locations (1)

Maastricht University Medical Center +; 🇳🇱 Maastricht, Netherlands