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Oxytocin Effects on Food Motivation Pathways
Plain-language guide to NCT02276677: early phase 1 randomized trial of Oxytocin, 10 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02276677
- Phase
- early phase 1
- Status
- completed
- Start
- 2014-10
- Completion (planned or actual)
- 2015-05
- Participants
- 10 (actual)
- Design
- randomized, triple-blind, other
- Conditions studied
- Overweight and Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (early phase 1) is built around Oxytocin.
Oxytocin is a peptide hormone produced in the brain that regulates food intake.
However, the mechanisms for this effect in humans is not yet clear.
It had two arms (groups): Oxytocin (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 10 actual participants took part.
It was open to men only aged from 18 years up to 45 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Age 18-45 years old. 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; history of diabetes mellitus.
How the Study Was Run
Design: randomized, crossover and triple-blind.
Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.
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 and investigator.
It started in 2014-10 with completion listed for 2015-05.
It ran at 1 site in United States.
Its stated primary purpose is other.
What Was Measured
The main thing measured (primary outcome): Change in functional magnetic resonance imaging activation of food motivation brain regions (time frame: Functional magnetic resonance imaging at T60 min after oxytocin/placebo).
It also tracked 1 secondary outcome, for example Change in hormone levels (cholecystokinin, glucagon-like peptide-1).
What This Means in Plain Language
Put simply, this is a early phase 1, randomized trial of Oxytocin in 10 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.
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.