Effect of Ghrelin on Decision-Making

Effect of Ghrelin on Nutritional and Financial Decision-Making

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.

Study Overview

• Status: Withdrawn
• Conditions: Obesity; Healthy Volunteers
• Intervention / Treatment: Drug: Ghrelin; Drug: Saline

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 Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Duke Sociology-Psychology Building 417 Chapel Drive

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Ghrelin; Subjects will receive a subcutaneous injection of synthetic acyl ghrelin (12 µg/kg) at the start of the study.; Other Names: Acylated Ghrelin; Octanoyl Ghrelin
Placebo Comparator: 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.	Drug: Saline; Subjects will receive a subcutaneous injection of saline (0.9%) at the start of the study.
Experimental: 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.	Drug: Ghrelin; Subjects will receive a subcutaneous injection of synthetic acyl ghrelin (12 µg/kg) at the start of the study.; Other Names: Acylated Ghrelin; Octanoyl Ghrelin
Placebo Comparator: 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.	Drug: Saline; Subjects will receive a subcutaneous injection of saline (0.9%) at the start of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Approximately 25 minutes
Effect of Ghrelin on temporal choices in Task 2	The difference in the proportion of smaller sooner and larger later choices in the Saline and Ghrelin conditions	Approximately 25 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jenny Tong, MD, MPH
• Investigators: Principal Investigator: Jenny Tong, MD, MPH, Duke Molecular Physiology Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: May 25, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (Actual): June 26, 2017

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 23, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Obese; Healthy Volunteers; Decision-making; Ghrelin
• Other Study ID Numbers: Pro00077515

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No