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Postprandial IHL and IMCL Measured With Proton Magnetic Resonance Spectroscopy

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ClinicalTrials.gov Identifier: NCT01709643
Recruitment Status : Completed
First Posted : October 18, 2012
Last Update Posted : September 20, 2016
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Postprandial IHL and IMCL Dynamics Dietary Supplement: High fat breakfast Dietary Supplement: HF breakfast with protein Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Postprandial Intrahepactic Lipid (IHL) and Intramyocellular Lipid (IMCL) Levels Measured With Proton Magnetic Resonance Spectroscopy (1H-MRS)
Study Start Date : September 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
High fat breakfast lean subjects
Subjects will consume a high fat breakfast, containing of sausage rolls. Energy content of the breakfast will be set to 50 % of the recommended daily calorie intake (BMR times 1.3).
Dietary Supplement: High fat breakfast
The HF breakfast will consist of sausage rolls ("saucijzenbroodjes"), available at the local Albert Heijn (Albert Heijn B.V., Zaandam, The Netherlands).
High fat breakfast,obese subjects
Subjects will consume a high fat breakfast, containing of sausage rolls. Energy content of the breakfast will be set to 50 % of the recommended daily calorie intake (BMR times 1.3).
Dietary Supplement: High fat breakfast
The HF breakfast will consist of sausage rolls ("saucijzenbroodjes"), available at the local Albert Heijn (Albert Heijn B.V., Zaandam, The Netherlands).
HF breakfast with protein,lean subjects
For the HFP breakfast, the subjects will consume 'Protifar' (Nutricia, Cuijk, The Netherlands) in addition to the sausage rolls. The amount of added proteins will be calculated to assure that the total energy content from proteins in the breakfast equals 20 %,
Dietary Supplement: HF breakfast with protein
For the HFP breakfast, the subjects will consume 'Protifar' (Nutricia, Cuijk, The Netherlands) in addition to the sausage rolls.
HF breakfast with protein,obese subjects
For the HFP breakfast, the subjects will consume 'Protifar' (Nutricia, Cuijk, The Netherlands) in addition to the sausage rolls. The amount of added proteins will be calculated to assure that the total energy content from proteins in the breakfast equals 20 %,
Dietary Supplement: HF breakfast with protein
For the HFP breakfast, the subjects will consume 'Protifar' (Nutricia, Cuijk, The Netherlands) in addition to the sausage rolls.



Primary Outcome Measures :
  1. Difference between pre- and postprandial IHL and IMCL [ Time Frame: 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 :
  1. Difference between postprandial IHL and IMCL in high fat and high fat with extra protein breakfast [ Time Frame: 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.


Other Outcome Measures:
  1. Fat and fat free mass of subjects [ Time Frame: One week before the first MR measurements ]
    Body composition of the subjects is measured with underwaterweighing method

  2. Blood plasma insulin levels [ Time Frame: Ten minutes prior to high fat breakfast and 0.5, 1,2,3.5,4.5,5.5 hours after the high fat breakfast ]
  3. Blood plasma glucose levels [ Time Frame: Ten minutes prior to high fat breakfast and 0.5, 1,2,3.5,4.5,5.5 hours after the high fat breakfast ]
  4. Blood plasma free fatty acid level [ Time Frame: Ten minutes prior to high fat breakfast and 0.5, 1,2,3.5,4.5,5.5 hours after the high fat breakfast ]
  5. Blood plasma triglyceride level [ Time Frame: Ten minutes prior to high fat breakfast and 0.5, 1,2,3.5,4.5,5.5 hours after the high fat breakfast ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709643


Locations
Netherlands
Maastricht University Medical Center +
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Top Institute Food and Nutrition

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01709643     History of Changes
Other Study ID Numbers: METC 12-3-025
First Posted: October 18, 2012    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: October 2012