Healthy VolunteersPhase 1NCT03198143
Effect of Ghrelin on Decision-Making
A Phase 1 study testing Ghrelin and Saline in people with Healthy Volunteers and Obesity, run by Jenny Tong, MD, MPH at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Obesity
- What is being tested?
- Ghrelin and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2019to Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to speak and understand English
- BMI of 18.0 - 24.9 kg/m2 or 30.0 - 50.0 kg/m2
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Sociology-Psychology Building 417 Chapel Drive
Durham, North Carolina, 27708
About this study
Official title: Effect of Ghrelin on Nutritional and Financial Decision-Making
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.
Read the 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
- Being tested
- Ghrelin, Saline
- Keywords
- Decision-making, Ghrelin, Healthy Volunteers, Obese
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GhrelinDrug
Also called Acylated Ghrelin, Octanoyl Ghrelin
Subjects will receive a subcutaneous injection of synthetic acyl ghrelin (12 µg/kg) at the start of the study.
SalineDrug
Subjects will receive a subcutaneous injection of saline (0.9%) at the start of the study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Approximately 25 minutes
Secondary outcomes (4)
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.
Measured: Approximately 25 minutes
Number of fixations on foods during Task 1
The total number of fixations on each food option will be compared in both experimental conditions.
Measured: Approximately 25 minutes
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.
Measured: Approximately 25 minutes
Number of fixations on foods during Task 2
The total number of fixations on each monetary option will be compared in both experimental conditions.
Measured: Approximately 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study startOct 2019 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2022 (estimated)
Why it stopped: PI leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jenny Tong, MD, MPH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jenny Tong, MD, MPH, Duke University
- Investigators
- Jenny Tong, MD, MPH, Principal investigator, Duke Molecular Physiology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198143
- Sponsor's protocol ID
- Pro00077515
- Status last verified
- Jan 2020
- First submitted
- 25 May 2017
- Last updated
- 27 Jan 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ghrelin on Nutritional and Financial Decision-Making
- ClinicalTrials.gov ID
- NCT03198143
- Acronym / sponsor ID
- Pro00077515
- Conditions
- Healthy Volunteers, Obesity
- Keywords
- Decision-making, Ghrelin, Healthy Volunteers, Obese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI leaving institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jenny Tong, MD, MPHUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects - Ghrelin | Experimental | Drug: GhrelinHealthy 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. |
| Healthy Subjects - Saline | Placebo comparator | Drug: SalineHealthy 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. |
| Obese Subjects - Ghrelin | Experimental | Drug: GhrelinObese 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. |
| Obese Subjects - Saline | Placebo comparator | Drug: SalineObese 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ability to speak and understand English
- BMI of 18.0 - 24.9 kg/m2 or 30.0 - 50.0 kg/m2
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GhrelinAlso: Acylated Ghrelin, Octanoyl GhrelinSubjects will receive a subcutaneous injection of synthetic acyl ghrelin (12 µg/kg) at the start of the study. | Drug | Healthy Subjects - Ghrelin, Obese Subjects - Ghrelin |
| SalineSubjects will receive a subcutaneous injection of saline (0.9%) at the start of the study. | Drug | Healthy Subjects - Saline, Obese Subjects - Saline |
Primary outcome
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.
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
4 secondary outcomes
Dwell time on each choice during Task 1
Time frame: Approximately 25 minutes
Number of fixations on foods during Task 1
Time frame: Approximately 25 minutes
Dwell time on each choice during Task 2
Time frame: Approximately 25 minutes
Number of fixations on foods during Task 2
Time frame: Approximately 25 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny Tong, MD, MPH principal investigator
Duke Molecular Physiology Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ghrelin and Saline in people with Healthy Volunteers and Obesity, run by Jenny Tong, MD, MPH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Ghrelin on food choices in Task 1. (time frame: Approximately 25 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.