Effect of Ghrelin on Decision-Making

Phase 1WithdrawnNCT03198143

Jenny Tong, MD, MPH

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Conditions

Healthy Volunteers Obesity

Interventions

GhrelinDRUG

Subjects will receive a subcutaneous injection of synthetic acyl ghrelin (12 µg/kg) at the start of the study.

SalineDRUG

Subjects will receive a subcutaneous injection of saline (0.9%) at the start of the study.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Duke Sociology-Psychology Building 417 Chapel Drive

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Effect of Ghrelin on food choices in Task 1.

The difference in the proportion of healthy and unhealthy choices in the Saline and Ghrelin conditions.