The Safety and Effectiveness of Low and High Carbohydrate Diets
The Safety and Efficacy of Low and High Carbohydrate Diets
研究概览
详细说明
Despite the considerable mass appeal of popular diet books, such diet approaches lack data to support their efficacy and safety. Despite its widespread use for more than 30 years, the Atkins diet has never been evaluated in a large, randomized, controlled trial. This study will assess the short-term and long-term clinical effects of a low-carbohydrate diet and a high-carbohydrate diet in overweight and obese men and women.
Participants in this study will be randomly assigned to the Atkins diet (low-carbohydrate, unlimited fat and protein) or a conventional USDA diet (high-carbohydrate, low-fat). The study will evaluate the effects of each dietary approach on changes in: 1) weight and body composition; 2) metabolic and organ function; and 3) exercise tolerance. Each participant will be enrolled in the study for 2 years.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Colorado
-
Denver、Colorado、美国、80262
- University of Colorado
-
-
Missouri
-
St. Louis、Missouri、美国、63110
- Washington University
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
- Body mass index between 30 and 40
- Live and work within 1 hour of the study site
- Stable psychological status
Exclusion criteria
- History of heart disease, heart attack, or stroke
- Blood pressure >140/90 mmHg
- Abnormal cholesterol levels
- Significant psychiatric illness
- Any medication that affects weight or metabolic rate
- Presence or history of a chronic disease that is known to affect appetite, food intake, or metabolism (i.e., diabetes, thyroid disease, or cancer)
- Currently using antidepressants, steroids, tobacco, or illegal drugs
- Pregnant, breastfeeding, or planning pregnancy
- 10 lb change in weight within 6 months of study entry
- History of malignant arrhythmias or cerebrovascular, renal, or hepatic disease
- History of protein wasting diseases or gout
- Severe arthritis
- Osteoporosis
- Certain types of hormone replacement therapy
- Currently following a vegetarian diet
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：1
Low-calorie diet
|
low-calorie diet
|
|
实验性的：2
Low-carbohydrate diet
|
low-carbohydrate diet
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
weight change
大体时间：2 years
|
2 years
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
change in lipids
大体时间：2 years
|
2 years
|
|
blood pressure change
大体时间：2 years
|
2 years
|
|
Ketones
大体时间：2 years
|
2 years
|
|
Endothelial Function
大体时间：2
|
2
|
|
change in exercise endurance
大体时间：2 years
|
2 years
|
|
change in renal function
大体时间：2 years
|
2 years
|
|
change in bone density
大体时间：2 years
|
2 years
|
|
change in body composition
大体时间：2 years
|
2 years
|
合作者和调查者
合作者
调查人员
- 首席研究员：James Hill, PhD、University of Colorado, Denver
- 首席研究员：Holly Wyatt, MD、University of Colorado, Denver
- 首席研究员：Gary D Foster, PhD、University of Pennsylvania
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- R01AT001103-01 (美国 NIH 拨款/合同)
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