NCT03198143

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2019

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
2.3 years until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1.3 years

First QC Date

May 25, 2017

Last Update Submit

January 23, 2020

Conditions

Healthy VolunteersObesity

Keywords

Decision-makingGhrelinHealthy VolunteersObese

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Dwell time on each choice during Task 1

    Approximately 25 minutes

  • Number of fixations on foods during Task 1

    Approximately 25 minutes

  • Dwell time on each choice during Task 2

    Approximately 25 minutes

  • Number of fixations on foods during Task 2

    Approximately 25 minutes

Study Arms (4)

Healthy Subjects - Ghrelin

EXPERIMENTAL

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

Healthy Subjects - Saline

PLACEBO COMPARATOR

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

Obese Subjects - Ghrelin

EXPERIMENTAL

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

Obese Subjects - Saline

PLACEBO COMPARATOR

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

Interventions

GhrelinDRUG

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

Also known as: Acylated Ghrelin, Octanoyl Ghrelin
Healthy Subjects - GhrelinObese Subjects - Ghrelin
SalineDRUG

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

Healthy Subjects - SalineObese Subjects - Saline

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ability to speak and understand English
  • BMI of 18.0 - 24.9 kg/m2 or 30.0 - 50.0 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Sociology-Psychology Building 417 Chapel Drive

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

GhrelinSodium Chloride

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jenny Tong, MD, MPH

    Duke Molecular Physiology Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 25, 2017

First Posted

June 26, 2017

Study Start

October 1, 2019

Primary Completion

February 1, 2021

Study Completion

February 1, 2022

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)