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Completed

NCT Number: NCT02276677

Oxytocin Effects on Food Motivation Pathways

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.

In this study, the investigators will therefore examine the effect of a single dose of intranasal oxytocin (compared to placebo) on levels of appetite-regulating hormones and functional magnetic resonance imaging activation of areas of the brain involved in food motivation.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-45 years old
  • BMI 25-40
  • Regular breakfast eater (at least 4 times per week)
  • Stable weight within the past three months

Exclusion criteria

  • Psychiatric disease, use of psychotropic medications
  • History of eating disorder
  • History of excessive exercise within the last three months (having run more that 25 miles in any one week or having exercised more than ten hours in any one week)
  • History of diabetes mellitus
  • Active substance abuse
  • Hematocrit lower than the normal range
  • Gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection)
  • History of cardiovascular disease (such as hypertrophic cardiomyopathy, valvular heart disease, coronary heart disease, or coronary artery spasms)
  • Untreated thyroid disease
  • Tobacco use
  • Cardiac pacemaker, surgical aneurysm clips, neurostimulator, implanted pumps, metal fragments in body/eyes, nitroglycerin patch, severe claustrophobia

Treatment and study plan

Oxytocin

Drug

Single dose, intranasal

Other names: Syntocinon

Placebo

Drug

Single dose, intranasal

Primary outcomes

  1. Change in functional magnetic resonance imaging activation of food motivation brain regions

    Time frame: Functional magnetic resonance imaging at T60 min after oxytocin/placebo

Secondary outcomes

  1. Change in hormone levels (cholecystokinin, glucagon-like peptide-1)

    Time frame: Blood draws at T0, T30, T60, T120 min after oxytocin/placebo

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 28, 2014
Registry last updated
Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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