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临床试验/NCT04088344
NCT04088344已完成不适用

The Relative Contribution of Dietary Lipids vs. of Fatty Acids to Non-adipose Tissues and the Effect of a Carbohydrate-rich Diet in Healthy Subjects

Université de Sherbrooke2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2013年4月10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
14
试验地点
2
主要终点
whole-body organ-specific Dietary Fatty Acid (DFA) partitioning

研究概览

简要总结

The present research protocol will analyze whether a short-term modification (one week) of dietary habits would have an impact on the postprandial metabolism of dietary fatty acids and on their uptake by non-adipose tissues, in healthy subjects.

Each subject will participate in two protocols randomly determined and separated by a period of one month: a 7-day isocaloric diet (Protocol A) and a 7-day carbohydrate-rich diet containing +50% of the subject's energy needs. (Protocol B).

At the end of each diet, the subject will go through a postprandial metabolic study of 8 hours where different parameters will be measured thanks to PET imaging and perfusions of stables isotopes.

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects: subjects with normal glucose tolerance determined according to an oral glucose tolerance test and with a BMI above 25 kg/m2 without first degree of familial history of type 2 diabetes (parents, siblings).

排除标准

  • overt cardiovascular disease as assessed by medical history, physical exam, and abnormal ECG
  • treatment with a fibrate, thiazolidinedione, beta-blocker or other drug known to affect lipid or carbohydrate metabolism (except statins, metformin, and other antihypertensive agents that can be safely interrupted)
  • presence of liver or renal disease, uncontrolled thyroid disorder, previous pancreatitis, bleeding disorder, or other major illness
  • smoking (>1 cigarette/day) and/or consumption of >2 alcoholic beverages per day
  • prior history or current fasting plasma cholesterol level > 7 mmol/l or fasting TG > 5 mmol/l
  • any other contraindication to temporarily interrupt current meds for lipids or hypertension
  • being pregnant
  • not be barren

研究组 & 干预措施

Isocaloric diet (7 days)

Placebo Comparator

Protocole A

干预措施: PET imaging (Radiation)

Isocaloric diet (7 days)

Placebo Comparator

Protocole A

干预措施: perfusions of stable tracers (Other)

Isocaloric diet (7 days)

Placebo Comparator

Protocole A

干预措施: isocaloric diet (Dietary Supplement)

Isocaloric diet (7 days)

Placebo Comparator

Protocole A

干预措施: Liquid meal (Other)

Isocaloric diet (7 days)

Placebo Comparator

Protocole A

干预措施: Indirect calorimetry (Device)

Hypercaloric diet enriched with carbohydrate food (7 days)

Experimental

Protocole B

干预措施: Liquid meal (Other)

Hypercaloric diet enriched with carbohydrate food (7 days)

Experimental

Protocole B

干预措施: PET imaging (Radiation)

Hypercaloric diet enriched with carbohydrate food (7 days)

Experimental

Protocole B

干预措施: perfusions of stable tracers (Other)

Hypercaloric diet enriched with carbohydrate food (7 days)

Experimental

Protocole B

干预措施: Indirect calorimetry (Device)

Hypercaloric diet enriched with carbohydrate food (7 days)

Experimental

Protocole B

干预措施: Hypercaloric diet (Dietary Supplement)

结局指标

主要结局

whole-body organ-specific Dietary Fatty Acid (DFA) partitioning

时间窗: 2 months

will be determined by whole-body CT (16 mA) followed by PET acquisition of 18FTHA

Left ventricular function by Positron Emiting Positron (PET) ventriculography

时间窗: 2 months

will be determined using 11C-acetate PET/CT. 180 MBq will be administered by bolus injection at fasting. After a transmission scan and regional CT (40mA), a 30-min dynamic list-mode PET acquisition will be performed on a 18 cm-high thoraco-abdominal segment to include the left cardiac ventricle and most of the liver on a Philips Gemini TOF PET/CT

次要结局

  • Cardiac and hepatic oxidative metabolism index(2 months)
  • metabolites appearance rate(6 months)
  • Insulin secretion rate(4 months)
  • β-cell function(4 months)
  • Anthropometric parameters(2 months)
  • energy metabolism (whole body production)(4 months)
  • Insulin sensitivity(4 months)
  • Cardiac DFA uptake(2 months)
  • Cardiac and hepatic blood flow(2 months)
  • hormonal responses(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

André Carpentier

tenured professor

Université de Sherbrooke

研究点 (2)

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