Paleolithic Diet in the Treatment of Glucose Intolerance
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- change in weight and waist circumference
研究概览
简要总结
The purpose of this study is to determine whether a paleolithic diet improves glucose tolerance and insulin sensitivity in people with coronary heart disease and impaired glucose tolerance.
详细描述
There is uncertainty about the optimal diet in the prevention and treatment of glucose intolerance and diabetes type 2, disorders which are very common in patients with coronary heart disease (CHD). Earlier studies have generally focused on intakes of fat, carbohydrate, fiber, fruit and vegetables. Another approach compares foods that were available during human evolution with more recently introduced ones. Twenty-nine CHD patients with glucose intolerance or diabetes have been randomized to 1) a Paleolithic ("Old Stone Age") diet (n=14) based on lean meat, fish, fruit, vegetables, root vegetables, eggs, and nuts, or 2) a Consensus (Mediterranean-like) diet (n=15) based on whole grains, low-fat dairy products, vegetables, fruit, fish, and oils and margarines generally assumed to be healthy. Primary outcome variables are changes during 12 weeks in weight, waist circumference, and area under the curve for glucose (AUC Glucose0-120) and insulin (AUC Insulin0-120) at the oral glucose tolerance test.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Hyperglycemia
- •Coronary Heart Disease
- •Increased waist circumference
排除标准
- •Body mass index <20 kg/m2
- •Serum creatinine >130 µmol/L
- •Poor general condition
- •Unwillingness/inability to prepare food at home (by study participant or partner)
- •Participation in another medical trial
- •Chronic inflammatory bowel disease
- •Drug treatment with hypoglycemic agents
- •Drug treatment with warfarin
- •Drug treatment with oral steroid
结局指标
主要结局
change in weight and waist circumference
时间窗: 12 weeks
area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test
时间窗: 12 weeks
area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test
时间窗: 12 weeks
次要结局
- fasting plasma insulin(12 weeks)
- 120-min plasma glucose(12 weeks)
- fasting plasma glucose(12 weeks)
- 30-min plasma glucose(12 weeks)
- 30-min plasma insulin(12 weeks)
- 120-min plasma insulin(12 weeks)
研究者
Staffan Lindeberg
Ass prof
Lund University Hospital
