- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01709643
Postprandial IHL and IMCL Measured With Proton Magnetic Resonance Spectroscopy
September 19, 2016 updated by: Maastricht University Medical Center
Postprandial Intrahepactic Lipid (IHL) and Intramyocellular Lipid (IMCL) Levels Measured With Proton Magnetic Resonance Spectroscopy (1H-MRS)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maastricht, Netherlands
- Maastricht University Medical Center +
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: 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).
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The HF breakfast will consist of sausage rolls ("saucijzenbroodjes"), available at the local Albert Heijn (Albert Heijn B.V., Zaandam, The Netherlands).
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OTHER: 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).
|
The HF breakfast will consist of sausage rolls ("saucijzenbroodjes"), available at the local Albert Heijn (Albert Heijn B.V., Zaandam, The Netherlands).
|
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OTHER: 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 %,
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For the HFP breakfast, the subjects will consume 'Protifar' (Nutricia, Cuijk, The Netherlands) in addition to the sausage rolls.
|
|
OTHER: 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 %,
|
For the HFP breakfast, the subjects will consume 'Protifar' (Nutricia, Cuijk, The Netherlands) in addition to the sausage rolls.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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3 and 5 hours after high fat breakfast
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 and 5 hours after high fat breakfast
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Fat and fat free mass of subjects
Time Frame: One week before the first MR measurements
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Body composition of the subjects is measured with underwaterweighing method
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One week before the first MR measurements
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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
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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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|
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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
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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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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
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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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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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Ten minutes prior to high fat breakfast and 0.5, 1,2,3.5,4.5,5.5 hours after the high fat breakfast
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (ACTUAL)
June 1, 2014
Study Completion (ACTUAL)
September 1, 2014
Study Registration Dates
First Submitted
October 11, 2012
First Submitted That Met QC Criteria
October 16, 2012
First Posted (ESTIMATE)
October 18, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
September 20, 2016
Last Update Submitted That Met QC Criteria
September 19, 2016
Last Verified
October 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- METC 12-3-025
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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