The Effects of Oxytocin in Obese Adults

What Was Tested

The trial (phase 2) is built around Oxytocin.

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in obese adults, ages 18-45 years old.

It had two arms (groups): oxytocin (experimental) and placebo (placebo comparator).

Placebo nasal spray (4 times per day for 8 weeks).

The registry classes the interventions as drug.

Who Took Part

61 actual participants took part.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 18-45 years old;. BMI greater than or equal to 30 kg/m2.

The full record lists 2 inclusion and 12 exclusion criteria; among the exclusions: history of medication changes within 4 weeks of enrollment;; active substance use;; history of cardiovascular disease, gastrointestinal disorders, bariatric surgery, epilepsy, untreated thyroid disease;.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

The Oxytocin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

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

It started in 2017-07-01 with completion listed for 2022-05-20.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean Difference in Weight Loss Between Oxytocin and Placebo 8 Weeks After Baseline (time frame: Baseline to 8 weeks).

It also tracked 3 secondary outcomes, for example Change in Resting Energy Expenditure After 8 Weeks of Oxytocin Versus Placebo, Change in Fat Depots After 8 Weeks of Oxytocin Versus Placebo and Difference in Caloric Intake After 6 Weeks of Oxytocin Versus Placebo.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 61 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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