The Role of Oxytocin-receptor Signalling in Physiological Regulation of Eating Behaviour in Individuals with Obesity

What Was Tested

This registered not phased trial tested Oxytocin.

The present study evaluates appetite, glucose metabolism, gastrointestinal motility and energy expenditure in men and women with obesity (BMI 30-40 kg/m2) under oxytocin exposure compared to placebo.

It had two arms (groups): Oxytocin (experimental) and Placebo (other).

The registry classes the interventions as drug and other.

More on the Plan

In a randomised, double-blind, placebo-controlled, crossover fashion, 24 participants will complete two experimental days (A and B) including a mixed meal test and an ad libitum meal test.

The procedures during the two experimental days are similar except for intravenous infusion of oxytocin on experimental day A and placebo (saline) on experimental day B, respectively.

On experimental days, oxytocin or placebo infusion will be started at timepoint -60 minutes.

At timepoint 0 minutes, participants will ingest a liquid mixed meal.

Who Took Part

The registry lists 25 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Age 18-65 years. BMI between 30 and 40 kg/m2 (both included). Percentage body fat (BF%) ≥25 for men and ≥32 for women (assessed by bioelectrical impedance analysis). Informed oral and written consent.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: anaemia (haemoglobin below normal range); alanine aminotransferase (alt) \>2 times normal values; history of hepatobiliary and/or gastrointestinal disorder(s).

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

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

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

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2024-01-01 with completion listed for 2024-09-04.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Ad libitum food intake (time frame: Timepoint 190-220 minutes).

It also tracked 73 secondary outcomes, for example Ad libitum food intake, Sensations of hunger, Sensations of satiety, Sensations of fullness, Sensations of prospective food intake and Sensations of nausea.

What This Means in Plain Language

Put simply, this is a not phased, 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.