跳至主要内容
临床试验/NCT00498394
NCT00498394已完成1 期

Effects of a Ketogenic Diet on Body Weight and Cardiovascular Risk Factors

University of Cincinnati2 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2000年6月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
103
试验地点
2
主要终点
Body weight

研究概览

简要总结

This pilot study is a randomized, controlled clinical trial to compare anthropometric and metabolic changes associated with six months of weight management by means of a very low carbohydrate diet or a calorically-restricted low fat diet. We hypothesized that the low fat diet would be associated with more weight loss and improvement of cardiovascular risk factors than the low carbohydrate diet.

详细描述

Low carbohydrate diets, including high-fat, 'ketogenic' diets, have moved to the forefront of popular diets promoted for weight loss in the United States. These diet plans have been aggressively marketed to millions of Americans every year. However, there has been virtually no rigorous study of low carbohydrate, high fat diets either with regard to efficacy in promoting weight loss or effects on cardiovascular risk factors. Because very low carbohydrate diets (i.e., the ketogenic diets) recommend increased intake of fat, and saturated fat, we hypothesized that following one of these diet plans could actually worsen important risk factors for cardiovascular disease. This is an issue of great importance because large numbers of people experiment with low carbohydrate diets despite not knowing their effects on blood pressure, plasma lipid levels, and glucose tolerance. Therefore, we have proposed a clinical trial to test our hypothesis. In this study, we will compare the effects of three months of a ketogenic diet (as promoted by Dr. Robert Atkins) with three months of a weight loss diet that conforms to the American Heart Association dietary guidelines in a group of 100 otherwise healthy obese subjects. During the course of the study, we will determine the effects of diet on 1) body weight, percent fat, and resting metabolic rate, 2) blood pressure, 3) plasma lipids, 4) measures of glucose tolerance, and 5) measures of psychological health and eating behaviors. This pilot study will provide the preliminary data needed to demonstrate the efficacy (or lack thereof) of a popular weight loss technique (i.e., the ketogenic diet) that is currently being criticized by professional organizations. Armed with preliminary data, the investigators plan to further investigate the long-term anthropometric and metabolic effects of ketogenic diets with a larger sample.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Obese men and women with a BMI of 30-34 kg/m2, at least 18 years of age, who have had stable body weight (i.e., no gain or loss of >5% of body weight) for the preceding six months, who have normal oral glucose tolerance, and who are able to commit to a six month study.

排除标准

  • Pregnancy, lactation, active medical or mental illness requiring treatment, recent (within 1 year) use of appetite suppressing compounds, previous use of the ketogenic diet.

结局指标

主要结局

Body weight

时间窗: 6 months

次要结局

  • Body fat via dual energy x-ray absorptiometry (DXA)(6 months)
  • Resting metabolic rate via indirect calorimetry(6 months)
  • Blood pressure(6 months)
  • Fasting plasma total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides(6 months)
  • Fasting insulin and glucose(6 months)
  • Psychological health and eating behaviors via surveys(6 months)

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验