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van CCT (UK)

van CCT (UK)

Study on dietary fat retention in liver using MRI

- candidate number23334
- NTR NumberNTR5557
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-okt-2015
- Secondary IDsABR38120 METC 12-2-034
- Public TitleStudy on dietary fat retention in liver using MRI
- Scientific TitleTracking of dietary fatty acids in liver by 1H-[13C]- magnetic resonance spectroscopy
- ACRONYMTracking 13C fatty acids in vivo
- hypothesisUsing non-invasive imaging techniques, fat accumulation and metabolism can be studied in ectopic fat stores. Particularly interesting in the field of food and nutrition is the application of 13C magnetic resonance spectroscopy (MRS) to follow the time-course of retention of dietary fat in human tissues in ‘real-time’. The objective is to develop and validate an in vivo magnetic resonance method to track 13C-labeled fatty acids to the liver in healthy subjects.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Non-Alcoholic Fatty Liver Disease (NAFLD)
- Inclusion criteriaInclusion criteria:
Lean subjects (study 1):
- Age 18-65 years
- Normal BMI 18-25 kg/m2
- Stable dietary habits
- Generally healthy, no medication use

Obese subjects (study 2):
- Age 18-65 years,
- Obese, BMI 30-35 kg/m2
- Stable dietary habits (no weight-reducing diet last year)
- Generally healthy, no medication use
- Exclusion criteriaPersons that have any of the following will be excluded from the study:
- Any medical condition requiring treatment and/or medication use
- Alcohol consumption of more than 20 g per day (± 2 units) or other drug abuse
- Unstable body weight (weight gain or loss > 3 kg in the past three months)
- Contraindications for MRI scan:
• Aneurysm clips
• Implanted neural stimulator
• Implanted cardiac pacemaker of defibrillator
• Cochlear implant
• Iron- containing corpora aliena in the eye or brain
• Artificial (heart) valves which is contraindicated for MRS
• Claustrophobia
- Subjects, who do not want to be informed about unexpected medical findings, or do not wish that their treating physician is informed, cannot participate in the study. Possible unexpected findings could include: dark or highlighted spots in the liver or contrast differences between different muscle groups. In case one of those unexpected findings are recognised by the performing researcher, a radiologist will be contacted first for advice. On his/her advice further investigations will be performed and/or the physician will be contacted.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-aug-2012
- planned closingdate30-sep-2017
- Target number of participants20
- InterventionsHigh fat meal with 13C labeled fatty acids
- Primary outcomeThe main study parameters per study-group are:
Studie 1 (lean subjects)
- Determination of the lowest dose that allows for sufficient signal to noise ratio and to determine time of maximal 13C accumulation in liver. Time point of maximal increase.
Studie 2 (obese subjects)
- Minimal dose for significant postprandial increase of enrichment in liver.
- Time point of maximal increase.
- Difference in dose compared to lean subjects.
- Secondary outcome• Total- and 13C-enriched blood plasma levels of FFA, triglycerides, glucose.
- Timepoints0h, 1.5h, 3h, 4.5h and 6h after the meal
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Top Institute Food & Nutrition
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD30-okt-2015 - 4-feb-2016

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