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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02276677
Other study ID # SPID 1127
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date October 2014
Est. completion date May 2015

Study information

Verified date April 2019
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Oxytocin
Single dose, intranasal
Placebo
Single dose, intranasal

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in functional magnetic resonance imaging activation of food motivation brain regions Functional magnetic resonance imaging at T60 min after oxytocin/placebo
Secondary Change in hormone levels (cholecystokinin, glucagon-like peptide-1) Blood draws at T0, T30, T60, T120 min after oxytocin/placebo
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