Intranasal Oxytocin and Food Intake in Obese Adolescents

What Was Tested

This registered phase 2 trial tested Oxytocin.

The purpose of the study is to determine the effect of intranasal OXT caloric intake and eating behaviors in otherwise healthy obese adolescents.

The primary objective of this study is to determine the effects of intranasal administration of oxytocin on food intake in obese, pubertal or post-pubertal adolescents (13 to \<18 years in girls, and 15 to \<20 years in boys).

It had two arms (groups): Syntocinon (=Oxytocin), then Placebo (experimental) and Placebo, then Syntocinon (=Oxytocin) (experimental).

The registry classes the interventions as drug.

More on the Plan

Participants will undergo a telephone screening and then, within 4 weeks, complete an in-person screening visit to determine eligibility.

Then, within 4 weeks they will be randomized to either OXT or placebo.

After a minimum 1-week (7-28 days) "washout," participants will cross-over to treatment with the other condition (i.e., placebo or OXT).

Who Took Part

It was open to people of any sex aged from 13 years up to 19 years.

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

Examples of who could join: Proficient in English. Pubertal or Post-Pubertal Females: 13 to \<18 years. Pubertal or Post-Pubertal Males: 15 to \<20 years. Parental/guardian permission (informed consent) and if appropriate, child assent.

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: laboratory abnormalities that indicate abnormal sodium level, liver or renal disease, or anemia:; seizure in the past 12 mos; history of gastrectomy, gastric bypass, small or large bowel resection.

How the Study Was Run

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

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

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, care provider, investigator and outcomes assessor.

It started in 2018-09 with completion listed for 2020-06.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Effect on Food Intake (time frame: 28 Days).

It also tracked 3 secondary outcomes, for example Adverse Events, Effect of OXT on Eating Behaviors at Mealtime (appetite) and Effect of OXT on Eating Behaviors at Mealtime (impulsivity).

What This Means in Plain Language

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

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

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