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Oxytocin for Weight Loss in Adolescents

Plain-language guide to NCT04551482: phase 2 randomized trial of Oxytocin, fat loss, obesity & body recomposition, 55 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04551482
Phase
phase 2
Status
recruiting participants
Start
2021-07-28
Completion (planned or actual)
2026-12-31
Participants
55 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
Obesity, Adolescent; Oxytocin
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin for fat loss, obesity & body recomposition.

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in youths with obesity, ages 10-18 years old.

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

The registry classes the interventions as drug.

More on the Plan

Data are currently lacking regarding effects of OXT administration in adolescents with obesity.

The current study is a 12-week randomized controlled trial (RCT) of OXT vs. placebo in 10-18-year old adolescents with obesity.

Who Took Part

The registry lists 55 planned participants were the target.

It was open to people of any sex aged from 10 years up to 18 years.

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

Examples of who could join: Males and Females, 10-18 years. Obesity (BMI ≥95th percentile for age and gender). Willingness to maintain current diet and lifestyle for the duration of study participation.

The full record lists 3 inclusion and 17 exclusion criteria; among the exclusions: current substance abuse; greater than 5kg weight loss over 3 months;; follows a nonstandard diet (e.g., paleo, atkins, raw diet, macrobiotic diet).

How the Study Was Run

Design: randomized, parallel-group and double-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 fat loss, obesity & body recomposition participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant and investigator.

It started in 2021-07-28 with completion listed for 2026-12-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Body mass index (BMI) (time frame: 12 weeks).

It also tracked 2 secondary outcomes, for example Lean mass and Fat mass and Fasting Resting Energy Expenditure (kCal).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 55 people with fat loss, obesity & body recomposition.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, Fat loss, obesity & body recomposition research.

Our Notes on the Compound

Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.