Effect of Ghrelin on Decision-Making

Jenny Tong, MD, MPH

Status and phase: Withdrawn; Phase 1

Conditions: Healthy Volunteers; Obesity

Treatments: Drug: Ghrelin; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03198143

Pro00077515

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18 to 40 years old

Volunteers: 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 4 patient groups, including a placebo group

Healthy Subjects - Ghrelin

Experimental group

Description:

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.

Treatment:

Drug: Ghrelin

Healthy Subjects - Saline

Placebo Comparator group

Description:

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.

Treatment:

Drug: Saline

Obese Subjects - Ghrelin

Experimental group

Description:

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.

Treatment:

Drug: Ghrelin

Obese Subjects - Saline

Placebo Comparator group

Description:

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.

Treatment:

Drug: Saline