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