Effect of Ghrelin on Decision-Making

Obesity Clinical Trial

Official title:

Effect of Ghrelin on Nutritional and Financial Decision-Making

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03198143
• Other study ID #: Pro00077515
• Status: Withdrawn
• Phase: Phase 1
• Start date: October 2019
• Est. completion date: February 2022

Study information

• Verified date: January 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2022
• Est. primary completion date: February 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers
• Obesity

Intervention

Drug:
• Ghrelin
Subjects will receive a subcutaneous injection of synthetic acyl ghrelin (12 µg/kg) at the start of the study.
• Saline
Subjects will receive a subcutaneous injection of saline (0.9%) at the start of the study.

Locations

Country	Name	City	State
United States	Duke Sociology-Psychology Building 417 Chapel Drive	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Jenny Tong, MD, MPH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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