Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Men and Women

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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-01-31

Brief Summary

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Exciting advances have led to the concept that hormones can modulate appetite and food intake. Oxytocin is a peptide hormone that is released in regions throughout the brain, including areas involved in food motivation. Animal studies suggest that oxytocin may reduce food intake. The effects of oxytocin administration on eating behavior in humans, which could have important implications in eating-related disorders ranging from obesity to anorexia nervosa, have not been investigated. This double-blind placebo-controlled cross-over study of single-dose oxytocin administration investigates whether:

1. Caloric intake will decrease following administration of oxytocin versus placebo
2. Appetite will decrease following administration of oxytocin versus placebo
3. Resting energy expenditure will increase following administration of oxytocin versus placebo

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Detailed Description

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Conditions

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Eating Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Oxytocin

Intranasal oxytocin

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Intranasal oxytocin 24 IU single-dose administration

Placebo

Intranasal placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intranasal Placebo single-dose administration

Interventions

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Oxytocin

Intranasal oxytocin 24 IU single-dose administration

Intervention Type DRUG

Placebo

Intranasal Placebo single-dose administration

Intervention Type DRUG

Other Intervention Names

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Syntocinon (Novartis)

Eligibility Criteria

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Inclusion Criteria

* 18-45 years old
* BMI 18.5-24.9, 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
* History of diabetes mellitus
* Active substance abuse
* Hematocrit below 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes