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临床试验/NCT02018237
NCT02018237已完成不适用

The Effect of High Fructose Corn Syrup Feeding in Nonalcoholic Fatty Liver Disease

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2012年3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
47
试验地点
1
主要终点
Change in intrahepatic triglyceride (IHTG) content

研究概览

简要总结

The purpose of this research study is to learn more about how high fructose corn syrup, a sugar used to sweeten drinks and foods, affects metabolism in obese persons with and without nonalcoholic fatty liver disease. Eligible participants will be studied before and after eating a diet high in high fructose corn syrup or a standard diet (low in high fructose corn syrup) for four weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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
是

入选标准

  • •IHTG >6.5% or <5%
  • •BMI 30.0-45.0 kg/m²
  • •Sedentary
  • •Consume <10% calories from high fructose corn syrup
  • •Weight stable for previous 3 months

排除标准

  • •IHTG 5.1-7.9%
  • •Adults over 65 years
  • •Lactating
  • •Exercise >1.5 hours/week
  • •Hepatitis B or C
  • •History of liver disease
  • •History of alcohol abuse
  • •Severe hypertriglyceridemia (>300 mg/dl)
  • •Anemia (Hemoglobin <10mg/dl)
  • •Not weight stable

研究组 & 干预措施

NAFLD

Active Comparator

Subjects with nonalcoholic fatty liver disease (NAFLD) will complete baseline testing and then be assigned to either the high fructose corn syrup diet or the standard diet (low in high fructose corn syrup) for 4 weeks. Post intervention testing will be completed after the subjects have completed the 4 week diet intervention.

干预措施: High fructose corn syrup diet (Behavioral)

NAFLD

Active Comparator

Subjects with nonalcoholic fatty liver disease (NAFLD) will complete baseline testing and then be assigned to either the high fructose corn syrup diet or the standard diet (low in high fructose corn syrup) for 4 weeks. Post intervention testing will be completed after the subjects have completed the 4 week diet intervention.

干预措施: Standard diet (low in high fructose corn syrup) (Behavioral)

Non-NAFLD

Active Comparator

Subjects without nonalcoholic fatty liver disease (Non-NAFLD) will complete baseline testing and then be fed a high fructose corn syrup diet for 4 weeks. Post intervention testing will be completed after the subjects have completed the 4 week diet intervention.

干预措施: High fructose corn syrup diet (Behavioral)

结局指标

主要结局

Change in intrahepatic triglyceride (IHTG) content

时间窗: 4 weeks

Determine the effect of 4-week isocaloric diet high in high fructose corn syrup (HFCS) on IHTG content measured by magnetic resonance spectroscopy (MRS).

Uric acid metabolism

时间窗: 4 weeks

Determine the effect of 4-week isocaloric diet high in HFCS on uric acid metabolism by measuring post-prandial serum uric acid concentrations and using stable isotope tracer method.

Hepatic lipid metabolism

时间窗: 4 weeks

Determine the effect of 4-week isocaloric diet high in HFCS on hepatic lipid metabolism \[de novo lipogenesis, very low density lipoprotein-triglyceride (VLDL-TG) and very low density lipoprotein-Apolipoprotein B100 (VLDL-ApoB) secretion rates\] by using stable isotope tracer methods.

Multi-organ insulin sensitivity

时间窗: 4 weeks

Determine the effect of 4-week isocaloric diet high in HFCS on multi-organ insulin sensitivity by using a one stage hyperinsulinemic euglycemic clamp procedure in conjunction with muscle and adipose tissue biopsies.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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