Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Men and Women

What Was Tested

In this early phase 1 trial, researchers set out to test Oxytocin.

Exciting advances have led to the concept that hormones can modulate appetite and food intake.

Oxytocin is a peptide hormone that is released in regions throughout the brain, including areas involved in food motivation.

It had two arms (groups): Oxytocin (active comparator) and Placebo (placebo comparator).

Intranasal oxytocin.

Intranasal placebo.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 25 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: 18-45 years old. BMI 18.5-24.9, 25-40. Regular breakfast eater (at least 4 times per week). Stable weight within the past three months.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: psychiatric disease; use of psychotropic medications; history of eating disorder.

How the Study Was Run

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

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

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2012-01 with completion listed for 2014-01.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Caloric intake (time frame: +60 minutes after drug/placebo).

It also tracked 2 secondary outcomes, for example Appetite and Resting energy expenditure.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 25 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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