Postprandial IHL and IMCL Measured With Proton Magnetic Resonance Spectroscopy

NCT01709643 | Completed

• 1 other identifier: METC 12-3-025
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Postprandial IHL and IMCL Dynamics

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Difference between postprandial IHL and IMCL in high fat and high fat with extra protein breakfast

  3 and 5 hours after high fat breakfast

Other Outcomes (5)

• Fat and fat free mass of subjects

  One week before the first MR measurements

• 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

• 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

Study Arms (4)

High fat breakfast lean subjects

OTHER

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

High fat breakfast,obese subjects

OTHER

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

HF breakfast with protein,lean subjects

OTHER

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

HF breakfast with protein,obese subjects

OTHER

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

Interventions

High fat breakfast DIETARY_SUPPLEMENT

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 lean subjects; High fat breakfast,obese subjects

HF breakfast with protein DIETARY_SUPPLEMENT

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

HF breakfast with protein,lean subjects; HF breakfast with protein,obese subjects

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Top Institute Food and Nutrition: collaborator

Study Sites (1)

Maastricht University Medical Center +

Maastricht, Netherlands

Location

Related Publications (1)

• Lindeboom L, Nabuurs CI, Hesselink MK, Wildberger JE, Schrauwen P, Schrauwen-Hinderling VB. Proton magnetic resonance spectroscopy reveals increased hepatic lipid content after a single high-fat meal with no additional modulation by added protein. Am J Clin Nutr. 2015 Jan;101(1):65-71. doi: 10.3945/ajcn.114.094730. Epub 2014 Nov 5.

  PMID: 25527751 DERIVED

MeSH Terms

Interventions

Proteins

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 18, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 20, 2016

Record last verified: 2012-10

Locations

NL (1)