Postprandial IHL and IMCL Measured With Proton Magnetic Resonance Spectroscopy

Postprandial IHL and IMCL Dynamics Clinical Trial

Official title:

Postprandial Intrahepactic Lipid (IHL) and Intramyocellular Lipid (IMCL) Levels Measured With Proton Magnetic Resonance Spectroscopy (1H-MRS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01709643
• Other study ID #: METC 12-3-025
• Status: Completed
• Phase: N/A
• First received: October 11, 2012
• Last updated: September 19, 2016
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: October 2012
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Postprandial IHL and IMCL Dynamics

Intervention

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
For the HFP breakfast, the subjects will consume 'Protifar' (Nutricia, Cuijk, The Netherlands) in addition to the sausage rolls.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center +	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fat and fat free mass of subjects	Body composition of the subjects is measured with underwaterweighing method	One week before the first MR measurements	No
Other	Blood plasma insulin levels		Ten minutes prior to high fat breakfast and 0.5, 1,2,3.5,4.5,5.5 hours after the high fat breakfast	No
Other	Blood plasma glucose levels		Ten minutes prior to high fat breakfast and 0.5, 1,2,3.5,4.5,5.5 hours after the high fat breakfast	No
Other	Blood plasma free fatty acid level		Ten minutes prior to high fat breakfast and 0.5, 1,2,3.5,4.5,5.5 hours after the high fat breakfast	No
Other	Blood plasma triglyceride level		Ten minutes prior to high fat breakfast and 0.5, 1,2,3.5,4.5,5.5 hours after the high fat breakfast	No
Primary	Difference between pre- and postprandial IHL and IMCL	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.	3 and 5 hours after high fat breakfast	No
Secondary	Difference between postprandial IHL and IMCL in high fat and high fat with extra protein 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	No