Effect of Ghrelin on Nutritional and Financial Decision-Making
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Effect of Ghrelin on food choices in Task 1.
研究概览
简要总结
This study evaluates the effect of the "hunger hormone" ghrelin on human decision-making. Participants will be given an injection of ghrelin or saline on different study days and will then be asked to make a series of computer-based decisions. The investigators hypothesize that ghrelin will increase participant's preference for energy-dense foods and will also increase impulsiveness in decision making.
详细描述
Ghrelin is a hormone made by the stomach that stimulates hunger and feeding behavior. How ghrelin affects human decision-making is poorly understood. This study will investigate the effect of ghrelin on nutrition-related and time-based decisions in humans. Participants eye movements will be tracked by a computer during the decision-making process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to speak and understand English
- •BMI of 18.0 - 24.9 kg/m2 or 30.0 - 50.0 kg/m2
排除标准
- •Diagnosis of diabetes mellitus (including gestational diabetes)
- •Active infections
- •History of malignant or inflammatory conditions, such as rheumatoid arthritis and inflammatory bowel disease
- •History of myocardial infarction or congestive heart failure
- •Active liver or kidney disease
- •Uncontrolled hypertension
- •Pituitary or adrenal disorders or neuroendocrine tumors
- •History of anorexia nervosa, bulimia, or eating disorders not otherwise specified (NOS); Score of "at risk" on the EAT-26 eating disorder screening tool
- •Diagnosis of attention-deficient/hyperactivity disorder (ADHD)
- •Malabsorptive gastrointestinal disease, gastroparesis, or history of gastrointestinal surgery
- •Pregnancy or lactation
- •Requirement of daily medications that alter gastrointestinal function (including, but not limited to, glucocorticoids, psychotropics, narcotics, and metoclopramide).
- •Requirement of glasses for impaired vision (including reading glasses). Subjects who wear contact lenses for vision correction will not be excluded.
- •Insufficient visual acuity to read and interpret the decision stimuli
- •Insufficient motor capabilities to press a button, move the joystick, or move their eyes to indicate a response
研究组 & 干预措施
Healthy Subjects - Ghrelin
Healthy subjects will arrive after consuming a standard meal 60 minutes prior to study onset. They will receive a single subcutaneous injection of human synthetic Acyl Ghrelin at the start of the study. 5 minutes post-injection, the subjects will receive written instructions and begin their first decision-making task on a computer.
干预措施: Ghrelin (Drug)
Healthy Subjects - Saline
Healthy subjects will arrive after consuming a standard meal 60 minutes prior to study onset. They will receive a single subcutaneous injection of 0.9% saline at the start of the study. 5 minutes post-injection, the subjects will receive written instructions and begin their first decision-making task on a computer.
干预措施: Saline (Drug)
Obese Subjects - Ghrelin
Obese subjects will arrive after consuming a standard meal 60 minutes prior to study onset. They will receive a single subcutaneous injection of human synthetic Acyl Ghrelin at the start of the study. 5 minutes post-injection, the subjects will receive written instructions and begin their first decision-making task on a computer.
干预措施: Ghrelin (Drug)
Obese Subjects - Saline
Obese subjects will arrive after consuming a standard meal 60 minutes prior to study onset. They will receive a single subcutaneous injection of 0.9% saline at the start of the study. 5 minutes post-injection, the subjects will receive written instructions and begin their first decision-making task on a computer.
干预措施: Saline (Drug)
结局指标
主要结局
Effect of Ghrelin on food choices in Task 1.
时间窗: Approximately 25 minutes
The difference in the proportion of healthy and unhealthy choices in the Saline and Ghrelin conditions.
Effect of Ghrelin on temporal choices in Task 2
时间窗: Approximately 25 minutes
The difference in the proportion of smaller sooner and larger later choices in the Saline and Ghrelin conditions
次要结局
- Dwell time on each choice during Task 1(Approximately 25 minutes)
- Number of fixations on foods during Task 1(Approximately 25 minutes)
- Dwell time on each choice during Task 2(Approximately 25 minutes)
- Number of fixations on foods during Task 2(Approximately 25 minutes)
研究者
Jenny Tong, MD, MPH
Associate Professor
Duke University