Effect of Ghrelin on Decision-Making

NCT ID: NCT03198143

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2022-02-28

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.

Conditions

Healthy Volunteers; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ghrelin

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Ghrelin

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

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

Interventions

Ghrelin

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

Intervention Type: DRUG

Saline

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

Intervention Type: DRUG

Other Intervention Names

Acylated Ghrelin; Octanoyl Ghrelin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jenny Tong, MD, MPH

OTHER

Sponsor Role: lead

Responsible Party

Jenny Tong, MD, MPH

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jenny Tong, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Duke Molecular Physiology Institute

Locations

Duke Sociology-Psychology Building 417 Chapel Drive

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00077515

Identifier Type: -

Identifier Source: org_study_id