Metabolic Consequences of High and Low Carbohydrate Diets
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
This study will examine the effects of a low carbohydrate diet versus a high carbohydrate diet on weight loss.
详细描述
The number of overweight and obese Americans has increased significantly in recent years. There are now many different diet plans being promoted by doctors and the media. The Atkins diet, a low carbohydrate nutritional plan, is especially popular; its advocates claim that following the diet will result in long-term weight loss with no negative effects. Another diet, called the Dietary Approaches to Stop Hypertension (DASH) diet, is a high carbohydrate diet designed to help treat and prevent high blood pressure. However, more thorough investigation of these claims is needed. This study will compare the short- and long-term effects of the Atkins diet to the (DASH) diet. This trial will enroll overweight and obese participants.
This study will last 30 months and will comprise two phases. Participants will be randomly assigned to either the Atkins or DASH diet for 30 months. During Phase 1, all participants will undergo 6 months of weekly group therapy to encourage weight loss. Phase 2 is a weight loss maintenance phase. During Phase 2, participants will have monthly meetings with a therapist for weight loss support. Study visits will occur at study entry and at Months 3 and 30. At each study visit, weight measurements, blood and urine collection, and x-rays will occur to determine participants' weight loss, cardiovascular health, kidney function, and bone density.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) of 27 to 50
- •Fasting glucose less than 126 mg/dl
- •Total fasting cholesterol less than 260 mg/dl
- •Total fasting triglycerides less than 400 mg/dl
- •Permission of primary care provider to participate in the study
- •Normal liver and kidney function
- •Willing to modify diet and other health behaviors
- •Willing to use an acceptable method of contraception for the duration of the study
排除标准
- •Any medical condition that may make weight loss medically inadvisable
- •Weigh more than 400 lbs
- •History of kidney failure
- •Current use of more than 3 blood pressure medications
- •Change in blood pressure medications within 3 months prior to study entry
- •Diagnosis of cardiovascular disease within 6 months prior to study entry
- •Cancer diagnosis within 2 years of study entry. Participants with basal cell skin cancer are not excluded.
- •History of psychiatric hospitalization within 2 years prior to study entry
- •Consumption of more than three alcoholic drinks a day
- •Type I or II diabetes
- •Current use of hypolipidemics, antipsychotics, hypoglycemics, glucocorticoids, or thyroid medication
- •Plan to move during study
- •Current participation in another clinical trial
- •Pregnancy or breastfeeding
结局指标
主要结局
Weight loss
时间窗: monthly
Excess weight loss (greater than 5 pounds a week)would trigger patient assessment.
次要结局
- Risk of cardiovascular disease(Every six months)
- bone health(end of study)
- kidney function(every six months)
- neuroendocrine mechanisms of hunger and satiety(end of study)