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Oxytocin Effects on Food Motivation Pathways

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02276677
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Elizabeth Austen Lawson, Massachusetts General Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Overweight and Obesity Drug: Oxytocin Drug: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Oxytocin Effects on Food Motivation Pathways
Study Start Date : October 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Oxytocin
Oxytocin 24 IU x 1
Drug: Oxytocin
Single dose, intranasal
Other Name: Syntocinon

Placebo Comparator: Placebo
Placebo 24 IU x 1
Drug: Placebo
Single dose, intranasal




Primary Outcome Measures :
  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 Outcome Measures :
  1. Change in hormone levels (cholecystokinin, glucagon-like peptide-1) [ Time Frame: Blood draws at T0, T30, T60, T120 min after oxytocin/placebo ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276677


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Elizabeth A Lawson, MD, MMSc Massachusetts General Hospital
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Responsible Party: Elizabeth Austen Lawson, Assistant Professor of Medicine, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02276677    
Other Study ID Numbers: SPID 1127
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Overweight
Body Weight
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs