Effect of Ghrelin on Decision-Making

Phase 1

Withdrawn

• Conditions: Healthy Volunteers; Obesity
• Interventions: Drug: Saline; Drug: Ghrelin

• Registration Number: NCT03198143
• Lead Sponsor: Jenny Tong, MD, MPH

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-05-25
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-26
• Study Start: 2019-10
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27
• Primary Completion: 2021-02
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Healthy Subjects - Saline	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 - Saline	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.
Healthy Subjects - Ghrelin	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.
Obese Subjects - Ghrelin	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.

Primary Outcome Measures

Name	Time	Method
Effect of Ghrelin on food choices in Task 1.	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	Approximately 25 minutes	The difference in the proportion of smaller sooner and larger later choices in the Saline and Ghrelin conditions

Secondary Outcome Measures

Name	Time	Method
Dwell time on each choice during Task 1	Approximately 25 minutes	For eye-tracking, total dwell time (in ms) on each item in a food choice will be compared in both experimental conditions.
Number of fixations on foods during Task 1	Approximately 25 minutes	The total number of fixations on each food option will be compared in both experimental conditions.
Dwell time on each choice during Task 2	Approximately 25 minutes	For eye-tracking, total dwell time (in ms) on each item in the monetary choice will be compared in both experimental conditions.
Number of fixations on foods during Task 2	Approximately 25 minutes	The total number of fixations on each monetary option will be compared in both experimental conditions.

Trial Locations

Locations (1)

Duke Sociology-Psychology Building 417 Chapel Drive; 🇺🇸 Durham, North Carolina, United States