Clinical trial NCT03198143: Effect of Ghrelin on Decision-Making
Official title: Effect of Ghrelin on Nutritional and Financial Decision-Making
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Volunteers
Obesity
Keywords: Decision-making
Ghrelin
Healthy Volunteers
Obese
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-06-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of Ghrelin on food choices in Task 1.
timeFrame: Approximately 25 minutes
measure: Effect of Ghrelin on temporal choices in Task 2
timeFrame: Approximately 25 minutes
Secondary outcomes:
measure: Dwell time on each choice during Task 1
timeFrame: Approximately 25 minutes
measure: Number of fixations on foods during Task 1
timeFrame: Approximately 25 minutes
measure: Dwell time on each choice during Task 2
timeFrame: Approximately 25 minutes
measure: Number of fixations on foods during Task 2
timeFrame: Approximately 25 minutes
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Sociology-Psychology Building 417 Chapel Drive
state: North Carolina
Study officials:
affiliation: Duke Molecular Physiology Institute
name: Jenny Tong, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: