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

Early Phase 1

Completed

• Conditions: Eating Behavior
• Interventions: Drug: Placebo; Drug: Oxytocin

• Registration Number: NCT01513499
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-11
• Study First Submitted QC: 2012-01-19
• Study First Posted: 2012-01-20
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Intranasal placebo
Oxytocin	Oxytocin	Intranasal oxytocin

Primary Outcome Measures

Name	Time	Method
Caloric intake	+60 minutes after drug/placebo

Secondary Outcome Measures

Name	Time	Method
Appetite	+55 (fasting) and +90 minutes (post-prandial) after drug/placebo	Assessed using a Visual Analogue Scale
Resting energy expenditure	+30 minutes after drug/placebo	Assessed using metabolic cart

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States