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Oxytocin Effects on Food Motivation Pathways

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02276677
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
7
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
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 :
Oct 1, 2014
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Oxytocin

Oxytocin 24 IU x 1

Drug: Oxytocin
Single dose, intranasal
Other Names:
  • Syntocinon

    		•
    Placebo Comparator: Placebo

    Placebo 24 IU x 1

    Drug: Placebo
    Single dose, intranasal

    Outcome Measures

    Primary Outcome Measures

    1. Change in functional magnetic resonance imaging activation of food motivation brain regions [Functional magnetic resonance imaging at T60 min after oxytocin/placebo]

    Secondary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

    • Principal Investigator: Elizabeth A Lawson, MD, MMSc, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Oct 28, 2014
    Last Update Posted:
    Apr 8, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Overweight
    Oxytocin

    Study Results

    No Results Posted as of Apr 8, 2019