Effect of Ghrelin on Decision-Making

What Was Tested

The trial (phase 1) is built around Ghrelin.

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.

It had four arms (groups): Healthy Subjects - Ghrelin (experimental), Healthy Subjects - Saline (placebo comparator), Obese Subjects - Ghrelin (experimental) and Obese 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 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 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.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

It was open to people of any sex aged from 18 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Ability to speak and understand English. BMI of 18.0 - 24.9 kg/m2 or 30.0 - 50.0 kg/m2.

The full record lists 2 inclusion and 15 exclusion criteria; among the exclusions: diagnosis of diabetes mellitus (including gestational diabetes); active infections; history of malignant or inflammatory conditions, such as rheumatoid arthritis and inflammatory bowel disease.

How the Study Was Run

The set-up was randomized, crossover and single-blind.

The participants were allocated by chance, so the Ghrelin group and the comparison group should start out alike.

Each person switched between Ghrelin and the comparison at some point, usually with a gap in between.

Only one side, usually the participants, was kept unaware of whether Ghrelin was given.

Those kept unaware of assignments: participant.

It started in 2019-10 with completion listed for 2021-02.

It ran at 1 site in United States.

Its stated primary purpose is health services research.

What Was Measured

Primary outcome: Effect of Ghrelin on food choices in Task 1 (time frame: Approximately 25 minutes). Effect of Ghrelin on temporal choices in Task 2 (time frame: Approximately 25 minutes).

It also tracked 4 secondary outcomes, for example Dwell time on each choice during Task 1, Number of fixations on foods during Task 1, Dwell time on each choice during Task 2 and Number of fixations on foods during Task 2.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Ghrelin in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Ghrelin compound page, all human trials.