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临床试验/NCT01709643
NCT01709643已完成不适用

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

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2012年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
1
主要终点
Difference between pre- and postprandial IHL and IMCL

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 18-40 years
  • •Stable dietary habits
  • •No use of medication
  • •Lean subjects: BMI 18-25 kg/m2
  • •Obese subjects: BMI 30-35 kg/m2

排除标准

  • •Any medical condition requiring treatment and/or medication use
  • •Alcohol consumption of more than 20 g per day (± 2 units)
  • •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

研究组 & 干预措施

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).

干预措施: High fat breakfast (Dietary Supplement)

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).

干预措施: High fat breakfast (Dietary Supplement)

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 %,

干预措施: HF breakfast with protein (Dietary Supplement)

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 %,

干预措施: HF breakfast with protein (Dietary Supplement)

结局指标

主要结局

Difference between pre- and postprandial IHL and IMCL

时间窗: 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.

次要结局

  • Difference between postprandial IHL and IMCL in high fat and high fat with extra protein breakfast(3 and 5 hours after high fat breakfast)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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