The Purpose of This Study is to Investigate the Role of Stress in Food Craving and Food Consumption by Examining Stress Response Using Subjective, Physiological and Neurobiological Measurements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Food Craving based on the Food Craving Inventory
研究概览
简要总结
The purpose of this study is to examine the role of stress in food craving and food consumption in obesity. Using experimentally validated guided imagery procedure, the investigators propose to examine the stress response using subjective, physiological and neurobiological measurements.
详细描述
One hundred and fifty men and women will participate in three laboratory sessions to assess stress responses to personal stress imagery, food cue imagery, and to neutral-relaxing imagery. Subjects will be distributed into 3 groups stratified by BMI category. Subject recruitment, eligibility determination, baseline assessments and script development will be conducted at the Yale Stress Center. Subjects will complete a variety of diagnostic, cognitive and psychological assessments, a comprehensive physical examination and blood work and will be involved in development of imagery scripts from personal stress, food cue and neutral-relaxing situations. Subjects will then be scheduled for three laboratory sessions at the Yale Stress Center. Subjects will also participate in an imagery and relaxation training session followed by three laboratory sessions. The three laboratory sessions will be conducted within a brief interval of days, when subjects will be exposed to a personal stress, a food cue and a neutral-relaxing imagery condition, one condition per day. The order of imagery conditions will be randomly assigned and counterbalanced across subjects in order to balance any influences due to order of imagery conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between ages 18-45 years
- •Able to read and write
- •Normal/lean BMI group: BMI 18.5-24.9 as calculated based on height and weight.
- •Overweight BMI group: BMI 25.0 - 29.9 as calculated based on height and weight Obese BMI group: BMI 30-35 as calculated based on height and weight.
- •Do not meet criteria for any current Axis I DSM-IV psychiatric diagnoses and provide negative urine toxicology screens during initial appointments and at admission for laboratory sessions.
排除标准
- •Meet current criteria for dependence on any psychoactive substance, including nicotine and caffeine
- •Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or antabuse
- •Any psychotic disorder or current psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders
- •Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded
- •Women on oral contraceptives, peri and post menopausal women, and those with hysterectomies
- •Pregnant and lactating women will be excluded.
结局指标
主要结局
Food Craving based on the Food Craving Inventory
时间窗: 60 minutes
An abbreviated assessment base don the Food Craving Inventory at plus 60 minutes. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.
次要结局
- food snack intake(30 minutes)