Response of Energy Peak Levels After Carbohydrates Are Eaten Glycemic Load and Satiety Study - Phase 1
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Blood Glucose over time
研究概览
简要总结
The study is to examine the effect of four diets differing in glycemic index and amount of carbohydrate on blood sugar and insulin and in hunger, satiety, and vigor.
详细描述
The extent to which a food raises blood sugar after its consumption is ranked using the Glycemic Index (GI). Foods with a high GI are those taht cause a large and rapid rise in blood sugar while those with a low GI produce small fluctuations in blood sugar. It is believed that low GI foods are advantageous for health since the swings in blood sugar and insulin resistant or diabetic. Interestingly, some studies suggest that low GI food make you less hungry and that this may play an important role in body weight regulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass index between 25-35 kg/m2
- •Fasting serum glucose
- •Fasting serum glucose < 125 mg/dl
- •Free of chronic disease
- •Willing to eat only the foods that are provided by the Center during the diet periods
- •Willing to abstain from the consumption of alcohol during the diet periods
- •Regularly cycling and willing not to become pregnant using birth control (abstinence, barrier methods, partner surgically sterile
- •Monophasic birth control (same dose each day)
- •Hormone replacement therapy
- •Post-menopausal (over 1 year without bleeding)
- •Have had partial hysterectomy over the age of 55
- •complete hysterectomy at any age
排除标准
- •Documented presence of atherosclerotic disease
- •Diabetes mellitus
- •Renal, hepatic, endocrine, gastrointestinal, hematological or other systemic disease
- •Body Mass Index <25 or > 35
- •History of drug or alcohol abuse in the last year
- •For women, pregnancy, breast feeding or postpartum < 6 months
- •History of depression or mental illness requiring treatment or medication within that last 6 months
- •Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence
- •Lifestyle or schedule incompatible with the study protocol
- •Planned continued use of dietary supplements through the study trial
- •Smoking or tobacco use
结局指标
主要结局
Blood Glucose over time
时间窗: 1 month
Blood glucose demonstrates that diets of different glycemic load result in measurable differences in serum glucose and insulin.
次要结局
- Visual Analog scores (VAS)(1 month)
研究者
Frank Greenway
Medial Principal Investigator
Pennington Biomedical Research Center