Pexacerfont for Reduction of Stress-Induced Food Craving and Eating in Humans
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 2
研究概览
简要总结
Background:
- Stress can cause people to give in to temptations to eat less healthily. People who are on weight loss diets often have problems sticking to their diets when they are stressed. Some tests have shown that the drug pexacerfont can help reduce stress-related seeking of high-calorie foods. However, it has not been tested on reducing food craving. Researchers want to test pexacerfont on people who are on diets to see if it can reduce stress-related food cravings.
Objectives:
- To see if pexacerfont can help reduce stress-induced food cravings.
Eligibility:
- Individuals between 21 and 65 years of age who are on a diet to control their weight.
Design:
- Participants will be screened with a physical exam and medical history. This study requires seven visits over about 35 days.
- Participants will take either pexacerfont or placebo pills during the study. They will have three pills every morning. They will record video of themselves taking the pills every day.
- Every evening, participants will fill out a questionnaire. It will ask questions about feelings and behaviors related to eating and food craving.
- Participants will have regular study visits while taking the pills. The visits will involve questions about stressful situations and food cravings. One visit will involve a mildly stressful math test, followed by tasting of different foods. This test will look at whether pexacerfont can affect food preferences. Participants will provide blood and saliva samples as directed at these study visits.
- Participants will have follow-up phone calls 1, 3, and 6 months after the end of the study.
详细描述
Objective: To evaluate pexacerfont, an orally available, brain-penetrant selective CRF1 antagonist, for its ability to modulate food craving and consumption in chronic unsuccessful dieters.
Study population: We will collect evaluable data from up to 90 restrained eaters (individuals who indicate a history of chronic yo-yo dieting by scoring 15 or higher on the Dietary Restraint Scale). To ensure that all participants have some degree of preoccupation with food, an additional inclusion criterion will be endorsement of the Restraint Scale item Do you give too much time and thought to food? Apart from their preoccupation with food, participants will be healthy. They can be either normal-weight or overweight (Body Mass Index (BMI) > 22kg/m2); this will be stratified across dose groups.
Frank eating disorders will be exclusionary.
Design: This will be a randomized, double-blind, between-groups study with two groups.
Participants will be stabilized on either pexacerfont or placebo for 28 days (300 mg/day loading dose for 7 days, followed by 100 mg/day maintenance dose for 21 days). On day 15, they will undergo a math-test stressor and have stress-induced food consumption and craving assessed in a bogus taste test and on visual-analog scales. During three subsequent visits between days 16 and 28, they will be exposed to three personalized imagery-induction scripts-one stress-related, one food-related, and one neutral/relaxing. Food craving and food consumption will be assessed on those visits as well.
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
- Double
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供