Oxytocin Effects on Food Motivation Pathways

NCT ID: NCT02276677

Last Updated: 2019-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Oxytocin

Oxytocin 24 IU x 1

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Single dose, intranasal

Placebo

Placebo 24 IU x 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single dose, intranasal

Interventions

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Oxytocin

Single dose, intranasal

Intervention Type DRUG

Placebo

Single dose, intranasal

Intervention Type DRUG

Other Intervention Names

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Syntocinon

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Austen Lawson

Assistant Professor of Medicine, Harvard Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth A Lawson, MD, MMSc

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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SPID 1127

Identifier Type: -

Identifier Source: org_study_id

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