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Postprandial IHL and IMCL Measured With Proton Magnetic Resonance Spectroscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Maastricht University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01709643
First received: October 11, 2012
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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 Intervention
Postprandial IHL and IMCL Dynamics
Dietary Supplement: High fat breakfast
Dietary Supplement: HF breakfast with protein

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (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)

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Difference between pre- and postprandial IHL and IMCL [ Time Frame: 3 and 5 hours after high fat breakfast ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Fat and fat free mass of subjects [ Time Frame: One week before the first MR measurements ] [ Designated as safety issue: No ]
    Body composition of the subjects is measured with underwaterweighing method

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: September 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709643

Contacts
Contact: Lucas Lindeboom, MSc +31433882937 lucas.lindeboom@maastrichtuniversity.nl
Contact: Christine Nabuurs, PhD +31433874951 christine.nabuurs@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University Medical Center + Recruiting
Maastricht, Netherlands
Contact: Lucas Lindeboom, MSc    +31433882937    lucas.lindeboom@maastrichtuniversity.nl   
Principal Investigator: Patrick Schrauwen, PhD         
Sponsors and Collaborators
Maastricht University Medical Center
Top Institute Food and Nutrition
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01709643     History of Changes
Other Study ID Numbers: METC 12-3-025
Study First Received: October 11, 2012
Last Updated: October 16, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

ClinicalTrials.gov processed this record on November 25, 2014