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Oxytocin Effects on Food Motivation Pathways

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight and Obesity

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oxytocin

Placebo

Arm Description

Oxytocin 24 IU x 1

Placebo 24 IU x 1

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 24, 2014
Last Updated
April 4, 2019
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02276677
Brief Title
Oxytocin Effects on Food Motivation Pathways
Official Title
Oxytocin Effects on Food Motivation Pathways
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
Oxytocin 24 IU x 1
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 24 IU x 1
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Syntocinon
Intervention Description
Single dose, intranasal
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single dose, intranasal
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in hormone levels (cholecystokinin, glucagon-like peptide-1)
Time Frame
Blood draws at T0, T30, T60, T120 min after oxytocin/placebo

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Lawson, MD, MMSc
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Oxytocin Effects on Food Motivation Pathways

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