Effect of Ghrelin on Nutritional and Financial Decision-Making
| Registry | NCT03198143 |
|---|---|
| Status | Withdrawn - PI leaving institution |
| Phase | Phase 1 |
| Study type | Interventional; randomized, crossover, masking: single, health services research |
| Sponsor | Jenny Tong, MD, MPH (Other) |
| Conditions | Healthy Volunteers, Obesity |
| Interventions | Ghrelin, Saline (Drug) |
| Dates | start 2019-10-01 (estimated), primary completion 2021-02-01 (estimated), completion 2022-02-01 (estimated), first posted 2017-06-26, last updated 2020-01-27 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Healthy Volunteers All trials for Obesity All trials of Ghrelin All trials of Saline
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Healthy Subjects - Ghrelin | Experimental | Drug: 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. |
| Healthy Subjects - Saline | Placebo comparator | Drug: 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. |
| Obese Subjects - Ghrelin | Experimental | Drug: 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. |
| Obese Subjects - Saline | Placebo comparator | Drug: 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. |
Sex: All, ages: 18 Years to 40 Years, accepts healthy volunteers
Inclusion Criteria: * Ability to speak and understand English * BMI of 18.0 - 24.9 kg/m2 or 30.0 - 50.0 kg/m2 Exclusion Criteria: * 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
| Facility | City | Country | Status |
|---|---|---|---|
| Duke Sociology-Psychology Building 417 Chapel Drive | Durham, North Carolina | United States |