Behavioral Response to Short-term (Two-day) Positive Energy Balance Through Overfeeding (ENERGY I)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Energy Intake
研究概览
简要总结
The purpose of this trial is to examine the metabolic and behavioral effects of a positive energy balance induced by adding food to the usual level of activity.
It is hypothesized that: 1) food intake will not differ significantly after 2 days of positive energy balance induced by a high carbohydrate vs. high fat diet when both diets are low in energy density, and 2) food intake will be higher after a positive energy balance induced by a high fat/high energy dense diet vs. a high fat/low energy dense diet.
详细描述
The purpose of this trial is to examine the metabolic and behavioral effects of a positive energy balance induced by adding food to the usual level of activity. During this study, we will induce a positive energy balance for two days by increasing food intake to 140% of baseline energy requirements and keeping energy expenditure constant. The following three diets, which vary in dietary fat and energy density (kcal/g), will be used to induce the positive energy balance in a within subjects or cross over design: 1) high fat/high energy density, 2) high fat/low energy density, and 3) high carbohydrate/low energy density. Food intake and activity will be measured for 4 days after each diet to quantify the response to positive energy balance and manipulation of dietary fat and energy density.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •You are between the ages of 18 and 50, inclusive, if you are a male or between the ages of 18 and 45, inclusive, if you are a female.
- •Your body mass index (BMI) is between 20 and 40 kg/m², inclusive.
- •For females, if you have regular menstrual periods, with no less than 28 day cycles. Monophasic birth control pills, copper IUD, Ortho Evra patch, NuvaRing or complete hysterectomy are also acceptable.
排除标准
- •You have a chronic disease that affects body weight, appetite, or metabolism, such as diabetes and cardiovascular disease.
- •You have irregular menstrual cycles, had a partial hysterectomy (still maintain ovaries), or use an IUD not made of copper.
- •You use prescriptions or over-the-counter medications or herbal products that affect metabolism or body weight (e.g. weight loss medications such as sibutramine, or orlistat).
- •You use a birth control pill that isn't monophasic or you receive Depro-Provera injections.
- •You have barriers to completing the study, such as work or family commitments.
- •You have symptoms of depression or excessive dietary restraint.
- •You use tobacco products.
- •You exercise more than 1 hour per day, 5 or more days per week.
结局指标
主要结局
Energy Intake
时间窗: 4 days following the 2 day overfeeding
Food intake will be measured for 4 days after positive energy balance by directly weighing foods before and after ad libitum lunch and dinner. All food intake testes will occur while the participant resides in the inpatient unit.
次要结局
- Energy Expenditure(4 days following 2 days of overfeeding)
研究者
Corby K. Martin
Principal Investigator
Pennington Biomedical Research Center