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Effect of Ghrelin on Decision-Making

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ClinicalTrials.gov Identifier: NCT03198143
Recruitment Status : Not yet recruiting
First Posted : June 26, 2017
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Jenny Tong, MD, MPH, Duke University

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Obesity Drug: Ghrelin Drug: Saline Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Effect of Ghrelin on Nutritional and Financial Decision-Making
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2022

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.




Primary Outcome Measures :
  1. Effect of Ghrelin on food choices in Task 1. [ Time Frame: Approximately 25 minutes ]
    The difference in the proportion of healthy and unhealthy choices in the Saline and Ghrelin conditions.

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


Secondary Outcome Measures :
  1. Dwell time on each choice during Task 1 [ Time Frame: 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.

  2. Number of fixations on foods during Task 1 [ Time Frame: Approximately 25 minutes ]
    The total number of fixations on each food option will be compared in both experimental conditions.

  3. Dwell time on each choice during Task 2 [ Time Frame: 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.

  4. Number of fixations on foods during Task 2 [ Time Frame: Approximately 25 minutes ]
    The total number of fixations on each monetary option will be compared in both experimental conditions.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198143


Contacts
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Contact: Laura Page, MD 919-684-5091 laura.page@duke.edu

Locations
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United States, North Carolina
Duke Sociology-Psychology Building 417 Chapel Drive Not yet recruiting
Durham, North Carolina, United States, 27708
Contact: Laura Page, MD    919-684-5091    laura.page@duke.edu   
Contact: Samyukta Dore    919-668-3635    ssd31@duke.edu   
Principal Investigator: Jenny Tong, MD, MPH         
Sponsors and Collaborators
Jenny Tong, MD, MPH
Investigators
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Principal Investigator: Jenny Tong, MD, MPH Duke Molecular Physiology Institute

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Responsible Party: Jenny Tong, MD, MPH, Associate Professor, Duke University
ClinicalTrials.gov Identifier: NCT03198143     History of Changes
Other Study ID Numbers: Pro00077515
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jenny Tong, MD, MPH, Duke University:
Decision-making
Ghrelin
Healthy Volunteers
Obese