Effect of Dietary Fat When Eaten With Fructose vs. Glucose on Insulin Resistance and Liver Fat
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Evidence to determine whether intake in beverages that provide 20% fructose or a similar beverage made with glucose given with a higher fat diet has an effect on your body weight, blood pressure, fats in your liver or your blood sugar.
研究概览
简要总结
This study is designed to test the effects on liver fat of varying fat intake in the presence of fructose or glucose. We hypothesize that higher dietary fat when eaten with fructose as compared to glucose will increase the amount of hepatic lipid as measured by magnetic resonance spectroscopy.
详细描述
After 2 screening visits including an exercise test, DEXA and CT scan, qualifiers begin a 7 day diet with 20% fat, 65% carbohydrate (with 20% glucose) and 15 % protein. Participants consume 2 meals per day at PBRC with lunch and weekend meals packed to go. Following a test day, participants are randomized to one of 3 diet assignments and then test again:
1)20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein 2)40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein 3)40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein On Day 7 and again 14 days later participants have labs, an oral Glucose tolerance test, hepatic and intramuscular lipid measures by MRS, vital signs and waist measurement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 28 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 25 and 35 kg/m2 inclusive
- •At least one of the following:
- •Impaired fasting glucose between 100-125 mg/dl inclusive
- •HDL below 40 mg/dl for men or below 50 mg/dl for females
- •Triglycerides between 150 mg/dl and 400 mg/dl inclusive
- •Blood pressure above or equal to 135 / 85 mm Hg
- •Waist circumference >94cm (37 inches) for men or >80cm for women
- •Mainly Healthy
排除标准
- •Unable or unlikely to eat study foods and only foods provided by PRBC
- •Taking routine medications except birth control pills
- •Smoke, Abuse drugs,or Alcohol
- •Pregnant or breastfeeding, irregular menstrual cycles, Post-menopausal,or PCOS
- •Diabetes, heart, lung, liver, blood, or Kidney disease
结局指标
主要结局
Evidence to determine whether intake in beverages that provide 20% fructose or a similar beverage made with glucose given with a higher fat diet has an effect on your body weight, blood pressure, fats in your liver or your blood sugar.
时间窗: One Month
次要结局
未报告次要终点
研究者
George A. Bray
Principal Investigator
Pennington Biomedical Research Center