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临床试验/NCT01103921
NCT01103921已完成不适用

Effects of 2-weeks Fructose & HFCS Consumption on Dyslipidemia & Insulin Resistance

University of California, Davis2 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
214
试验地点
2
主要终点
24-hour triglyceride area under the curve

研究概览

简要总结

The purpose of this study is to examine the effects of consumption of sugar-sweetened beverages on blood triglycerides and cholesterol, cholesterol concentrations, and the body's sensitivity to insulin.

详细描述

The study is designed as a prospective, blinded diet intervention study during which the participants consume either fructose- or HFCS-sweetened beverages (providing 10%, 17.5% or 25% of energy) with meals. In addition, there will be two control groups, with one group consuming 0% sugar beverages sweetened with sucralose and the other consuming glucose-sweetened beverages at 25% of energy requirement. Experimental procedures, including 24-hour serial blood sampling, post-heparin infusions, gluteal biopsies, Magnetic Resonance Imaging of the liver and the abdomen, and Oral Glucose Tolerance and Disposal Tests, are performed during baseline and at the end of a 2-week intervention period at the UC Davis Clinical and Translational Science Center (CTSC) Clinical Research Center (CCRC). During the inpatient periods, subjects are served energy balanced diets. The diets provide 15% of energy as protein, 30% as fat, and 55% as carbohydrate. During baseline testing, the carbohydrate content consists primarily of complex carbohydrate (>97%). During intervention the 55% carbohydrate will consist of 10% sugar/45% complex, 17.5% sugar/37.5% complex, or 25% sugar/30% complex depending on the diet group to which the subject is assigned. During the outpatient intervention periods, the subjects reside at home and are provided with fructose- or HFCS -sweetened beverages that are consumed with each meal along with a self-selected ad libitum (usual) diet.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Care Provider)

入排标准

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

入选标准

  • Body mass index between 18-35
  • Self report of stable body weight during the past six months

排除标准

  • Diabetes Mellitus
  • Evidence of liver disorder
  • Evidence of kidney disorder
  • Evidence of thyroid disorder
  • Systolic blood pressure consistently over 160mmHg or diastolic blood pressure over 900mmHg
  • Triglycerides > 400mg/dl
  • LDL-C > 240mg/dl
  • Hemoglobin < 8.5 g/dl
  • Current, prior (within 2 months), or anticipated use of any hypolipidemic or anti-diabetic agents
  • Use of Selective Serotonin Reuptake Inhibitors and anti-hypertensive medications
  • Any other condition that, in the opinion of the investigators, would put subject at risk
  • Strenuous exerciser
  • Pregnant or lactating women
  • Diet exclusions: food allergies, special dietary restrictions, habitual ingest of >2 alcoholic beverages/day

结局指标

主要结局

24-hour triglyceride area under the curve

时间窗: Baseline and 2-week intervention

32 serial blood samples are collected over a 24 hour period.

次要结局

  • Insulin sensitivity index(Baseline and 2-week intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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