Effect of Diet Composition on Weight Change and Metabolic Parameters
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Effect of Diet Composition on Weight Change and Metabolic Parameters
研究概览
简要总结
This study will assess the effect of high protein (HP) and high carbohydrate (HC) diets on weight loss and other metabolic parameters.
Rationale: The prevalence of obesity is on the rise in the US. The health hazards of obesity have been well established. The detrimental effects of obesity on cardiovascular, metabolic and psychological parameters as well as the excess cost to the national health budget are astounding. One way of treatment and prevention of obesity has been the use of diet and exercise. In the absence of well-established superiority of one diet over another, different scientifically unproven diets are in common use. A palatable diet providing satiety as well as all essential nutrients may go a long way in treating over-weight individuals. Another factor has been the long-term adherence to such weight loss regimens, which in general have been poor. Protein diets have been known to provide greater satiety and reduced energy intake than carbohydrate diets, but definite long-term studies are sparse. For this study the investigators will recruit and study 24 normal, pre-menopausal obese women (12 on HP diet and 12 on HC diet), and compare their weight loss and changes in metabolic parameters between the two diets.
详细描述
Population: Recruit and study 24 pre-menopausal women with the following inclusion criteria:
Age range 20 yrs to 50 yrs, BMI > 30 kg/m2 to < 55 kg/m2 Fasting glucose < 110 mg/dl and 120 minute OGTT < 170 mg/dl glucose Design: The study is designed to determine the follow
To compare the effects of high protein (HP) versus high carbohydrate (HC) diet during energy restriction on weight loss, body composition (lean and fat body mass) and bone mineral density in a free living out patient setting.
To assess the effects of HP versus HC diets on metabolic parameters including insulin sensitivity, protein and muscle break down, lipoprotein metabolism and basal metabolic rate.
Procedures: SCREENING VISIT 1:Individuals fulfilling the inclusion and exclusion criteria will be invited for the first screening visit (VS1). A brief study overview will be given along with a brief history and physical examination, height and weight measurements and blood drawn for chemistry profile and and Oral Glucose Tolerance Test (OGTT) to determine normal glucose handling.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age range 20 yrs to 50 yrs,
- •BMI > 30 kg/m2 to < 55 kg/m2
- •Fasting glucose < 110 mg/dl and 120 minute OGTT < 170 mg/dl glucose
排除标准
- 未提供
研究组 & 干预措施
high protein diet
12 subjects will be place on a high protein diet
干预措施: high protein diet (Dietary Supplement)
high protein diet
12 subjects will be place on a high protein diet
干预措施: high carbohydrate diet (Dietary Supplement)
high carbohydrate diet
12 subjects will be put on a high carbohydrate diet for 6 months
干预措施: high carbohydrate diet (Dietary Supplement)
结局指标
主要结局
Effect of Diet Composition on Weight Change and Metabolic Parameters
时间窗: 6 months on High Protein or High Carbohydrate diet
Outcome Measures: The effect of a high protein diet or a high carbohydrate diet provided to subjects for 6 months on metabolic parameters.
次要结局
- Effect of Diet Composition on Weight Change and Metabolic Parameters(6 months on a high protein or high carbohydrate diet)